A Randomised, Controlled Trial to Investigate the Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.

Bipolar disorders affect approximately 4.5 million people across the European Union (EU) and are associated with high annual healthcare and societal costs. Bipolar disorder I and II represent disorders that cause extreme fluctuation in a person's mood, energy, and ability to function, in which symptoms of (hypo)mania and depression alternate. The depressive episodes of bipolar disorders are often referred to as bipolar depression (BD). In other words: it is a phase/state of the disorder. For many patients with BD, the depressive polarity is often more pervasive and more debilitating than manic states, with estimates that depressed mood accounts for up to two-thirds of the time spent unwell, even with treatment. The burden of not received an effective treatment for BD is high: more severe psychopathology, higher rates of unemployment, more hospitalisations, lower quality of life, lower cognitive functioning, risk of suicide, comorbidities and poorer social and occupational functioning and thus more carer burden. For BD, the treatment guidelines are very heterogeneous, amongst other reasons because the disease is heterogeneous and treatments should be tailored to the patients. There is no clear treatment algorithm and it cannot yet be predicted which treatment will be effective. Especially the place of adjunctive antidepressants is under debate. Usually, for psychiatric disorders (including bipolar disorder), a patient is considered to be treatment-resistant is two medicinal treatments have been tried (in sufficient duration and dosage) without sufficient success. For BD, there is no consensus on when to consider a patient as treatment-resistant, but the most common definition is after one prior treatment failure. This raises the research question whether adjunctive antidepressants to treat BD should be introduced earlier in the treatment. Additionally, The INTENSIFY trial is part of the larger Horizon 2021 project, with the central goal of paving the way for a shift towards a treatment decision-making process tailored for the individual at risk for treatment resistance. To that end, we aim to establish evidence-based criteria to make decisions of early intense treatment in individuals at risk for treatment resistance across the major psychiatric disorders of schizophrenia, bipolar disorder and major depression.

Start Date31 Jan 2025

Sponsor / Collaborator

University Medical Center of Utrecht

[+1]

NCT05603104

/ RecruitingPhase 3IIT

A Randomised, Controlled Trial to Investigate the Effect of an Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.

Schizophrenia, bipolar and major depressive disorders collectively affect over 10 million people across the EU and are associated with annual healthcare and societal costs in excess of 100 billion Euros. When diagnosed with one of these disorders, patients are prescribed psychotropic medication such as antidepressants, mood stabilisers or antipsychotics. It is unknown whether this first-line treatment will be successful. After this first-line treatment fails, usually a second-line treatment is initiated, and when this is not successful either a third-line treatment is initiated. Third-line treatments are quite successful, especially when compared to second-line treatments. The research question is whether the third-line treatments (early-intensified treatments) would be more efficacious than the current second-line treatments (treatment as usual) for schizophrenia, bipolar and major depressive disorders. If this is indeed the case, this could lead to the prevention of unnecessary trials of ineffective treatments and adaptations of worldwide guidelines as well as a reduction of healthcare and societal costs.

Start Date30 Jan 2025

Sponsor / Collaborator

University Medical Center of Utrecht

[+1]

NCT06433635

/ Not yet recruitingPhase 4IIT

Sequential Multiple Assignment Randomized Trial for Bipolar Depression

This is a sequential multiple assignment randomized trial for adults (ages > 18) with a bipolar disorder type 1 diagnosis currently experiencing a depressive episode. It is a randomized pragmatic trial that will compare four commonly prescribed treatments for bipolar depression, which includes three FDA-approved medications (Cariprazine, Quetiapine and Lurasidone) and one antipsychotic/antidepressant combination (Aripiprazole/Escitalopram).

Start Date01 Sep 2024

Sponsor / Collaborator

The General Hospital Corp.

[+1]

100 Clinical Results associated with Quetiapine Fumarate

100 Translational Medicine associated with Quetiapine Fumarate

100 Patents (Medical) associated with Quetiapine Fumarate

5,560

Literatures (Medical) associated with Quetiapine Fumarate

01 Feb 2025·JOURNAL OF AFFECTIVE DISORDERS

Effect of CYP3A5*3 genotype on exposure and efficacy of quetiapine: A retrospective, cohort study

Article

Author: Liu, Shuai ; Zhou, Chunhua ; Hao, Yupei ; Yu, Jing ; Zhao, Yan ; Wang, Ziyi ; Yuan, Shizhao

BACKGROUND:

The involvement of cytochrome P450 3A5 (CYP3A5) in the metabolism of quetiapine has been proposed, though conclusive evidence is lacking. This study aimed to quantitatively assess the impact of CYP3A5 genetic variability on quetiapine exposure in a Chinese patient population.

METHODS:

Patient data were retrospectively collected from the database of the Mental Health Centre at the First Hospital of Hebei Medical University, covering the period from September 1, 2019, to July 1, 2023. The study included patients genotyped for CYP3A5 who were treated with quetiapine. Inclusion criteria for the analysis of pharmacokinetic parameters, such as serum concentrations of the drug and its metabolites, included oral administration of quetiapine, availability of information on the prescribed daily dose and concomitant medications, and the determination of steady-state blood levels at the time of sampling (after at least 3 days of continuous administration at the same dose). Exclusion criteria comprised polypharmacy with known CYP3A4 inducers or inhibitors, as well as patients with hepatic or renal insufficiency. The primary endpoint was the exposure to quetiapine and N-dealkylquetiapine, measured using dose-corrected concentrations (C/D). The secondary endpoint was the metabolism of quetiapine to N-dealkylquetiapine, assessed by the ratio of metabolite to parent drug concentrations. The third endpoint is the differences in adverse reactions, QTc intervals, and biochemical parameters among patients with different CYP3A5 genotypes.

RESULT:

Based on the inclusion and exclusion criteria, clinical data from 207 patients were ultimately included in the study. Of these, 20 patients had the CYP3A5*1/*1 genotype, 78 had the CYP3A5*1/*3 genotype, and 109 had the CYP3A5*3/*3 genotype. The CYP3A5*3 variant was found to significantly impact the metabolism of quetiapine. The C/D values for both quetiapine and N-dealkyl quetiapine were notably higher in individuals with the *3/*3 genotype compared to those with the *1/*1 and *1/*3 genotypes (P₁ < 0.001 and P₂ = 0.002, respectively). A comparison of the variability in metabolic ratios among different genotype groups revealed no significant difference (P = 0.067). However, a post hoc analysis indicated that the metabolic ratio in poor metabolizers was significantly lower than that in intermediate metabolizers (P = 0.021). The analysis of adverse reaction incidence and QTc intervals among different genotypes showed no statistically significant differences (P = 0.652, P = 0.486). However, comparison of biochemical parameters across different genotype groups revealed that alanine aminotransferase, uric acid, hemoglobin, and gamma-glutamyl transferase levels were significantly higher in patients with the CYP3A5*3/*3 genotype compared to those with the CYP3A5*1/*1 and CYP3A5*1/*3 genotypes.

CONCLUSION:

The results indicated that the genetic polymorphism of CYP3A5*3 significantly influences the metabolism of quetiapine. Specifically, carriers of the CYP3A5*3/*3 genotype exhibited higher blood levels of quetiapine, with a greater likelihood of these levels exceeding the therapeutic range. This finding underscores the need for clinicians to pay special attention to the efficacy and occurrence of adverse reactions when prescribing quetiapine to patients carrying the CYP3A5*3/*3 genotype.

01 Feb 2025·JOURNAL OF AFFECTIVE DISORDERS

Brain structural connectomic topology predicts medication response in youth with bipolar disorder: A randomized clinical trial

Article

Author: Adler, Caleb M. ; Tallman, Maxwell J. ; DelBello, Melissa P ; Zhang, Jingbo ; DelBello, Melissa P. ; Patino, L. Rodrigo ; Sweeney, John A. ; Strawn, Jeffrey R ; Klein, Christina C. ; Lei, Du ; Adler, Caleb M ; Gong, Qiyong ; Pinaya, Walter H.L. ; Tallman, Maxwell J ; Fleck, David E ; Fleck, David E. ; Patino, L Rodrigo ; Qin, Kun ; Mechelli, Andrea ; Sweeney, John A ; Li, Wenbin ; Klein, Christina C ; Strawn, Jeffrey R. ; Pinaya, Walter H L

BACKGROUND:

Response to pharmacotherapy varies considerably among youths with bipolar disorder (BD) and is poorly predicted by clinical or demographic features. It can take several weeks to determine whether medication for BD is clinically effective. Although neuroimaging biomarkers are promising predictors, few studies examined the predictive value of the brain connectomic topology.

METHODS:

BD-I youth (N = 121) with no prior psychopharmacotherapy were randomized to 6-weeks of double-blind quetiapine or lithium. Structural magnetic resonance imaging (MRI) was performed before medication and at one week after medication initiation. Brain structural connectome was established from the MRI scans, and topological metrics were calculated for each patient. Deep learning-based prediction model was built using baseline and one-week connectome topology to predict medication response at week 6.

RESULTS:

Both baseline topological metrics and one-week topological changes could predict treatment response with significant accuracy (73.8 % - 86.8 %). A longitudinally joint model combining baseline and one-week topology provided the highest accuracy (91.3 %). The transferability between models for quetiapine and lithium was relatively poor. In addition, predictions for the two drugs were driven by similar baseline but distinct one-week salient topological patterns.

LIMITATIONS:

Independent replication is needed to validate our preliminary findings.

CONCLUSION:

Brain structural connectomic topology at baseline and its acute changes within the first week enable accurate BD medication response prediction. The most contributive brain regions differed between prediction models for quetiapine and lithium after one week. These findings provide preliminary evidence for the development of neuroimaging-based biomarkers for guiding therapeutic interventions in youth with BD.

01 Jan 2025·ACTA PSYCHIATRICA SCANDINAVICA

Dosing levels of antipsychotics and mood stabilizers in bipolar disorder: A Nationwide cohort study on relapse risk and treatment safety

Article

Author: Lähteenvuo, Markku ; Tanskanen, Antti ; Hamina, Aleksi ; Taipale, Heidi ; Lintunen, Jonne ; Paljärvi, Tapio ; Tiihonen, Jari

Abstract:

Background:

Finding effective treatment regimens for bipolar disorder is challenging, as many patients suffer from significant symptoms despite treatment. This study investigated the risk of relapse (psychiatric hospitalization) and treatment safety (non‐psychiatric hospitalization) associated with different doses of antipsychotics and mood stabilizers in persons with bipolar disorder.

Methods:

Individuals aged 15–65 with bipolar disorder were identified from Finnish national health registers in 1996–2018. Studied antipsychotics included olanzapine, risperidone, quetiapine, aripiprazole; mood stabilizers lithium, valproic acid, lamotrigine, and carbamazepine. Medication use was divided into three time‐varying dose categories: low, standard, and high. The studied outcomes were risk of psychiatric hospitalization (relapse) and the risk of non‐psychiatric hospitalization (treatment safety). Stratified Cox regression in within‐individual design was used.

Results:

The cohort included 60,045 individuals (mean age 41.7 years, SD 15.8; 56.4% female). Mean follow‐up was 8.3 years (SD 5.8). Of antipsychotics, olanzapine and aripiprazole were associated with a decreased risk of relapse in low and standard doses, and risperidone in low dose. The lowest adjusted hazard ratio (aHR) was observed for standard dose aripiprazole (aHR 0.68, 95% CI 0.57–0.82). Quetiapine was not associated with a decreased risk of relapse at any dose. Mood stabilizers were associated with a decreased risk of relapse in low and standard doses; lowest aHR was observed for standard dose lithium (aHR 0.61, 95% CI 0.56–0.65). Apart from lithium, high doses of antipsychotics and mood stabilizers were associated with an increased risk of non‐psychiatric hospitalization. Lithium was associated with a decreased risk of non‐psychiatric hospitalization in low (aHR 0.88, 95% CI 0.84–0.93) and standard doses (aHR 0.81, 95% CI 0.74–0.88).

Conclusions:

Standard doses of lithium and aripiprazole were associated with the lowest risk of relapse, and standard dose of lithium with the lowest risk of non‐psychiatric hospitalization. Quetiapine was not associated with decreased risk of relapse at any dose.

News (Medical) associated with Quetiapine Fumarate

03 Sep 2024

·www.echemi.com

After Trials on 703 Patients, Fruquintinib's Application is Rejected, OS Data Proves to Be a Roadblock!

On August 30, HUTCHMED officially announced that it had voluntarily withdrawn its marketing application for fuquinitinib for second-line gastric cancer. This decision was made on the basis that, after in-depth communication with the Center for Drug Evaluation (CDE) of the State Drug Administration and members of its external expert committee, the Company realized that the information submitted so far is not sufficient to meet the approval requirements of the marketing application for the new indication, and therefore further research and data support are needed. Industry observers say this is not surprising. The marketing application for the new indication for fuquintinib was based on data from FRUTIGA's Phase III study, in which only progression-free survival (PFS) achieved the desired effect, while overall survival (OS) improved but was not statistically significant among the two primary endpoints. This shows that CDE is gradually integrating with FDA and paying increasing attention to OS, a key standard. It is well known that the central goal of demonstrating the efficacy of oncology drugs in development is to extend overall survival (OS) of patients. Although multiple alternative endpoints, including PFS, have been used in the past to help bring numerous oncology drugs to market for a variety of reasons, alternative endpoints cannot replace OS as the gold standard. In the past two years, with the tightening of FDA review standards, those drugs that have greater side effects and fail to meet the OS gold standard have been gradually withdrawn from the market, and the approval of new drugs has become more stringent. The current withdrawal of Fuquinitinib appears to signal a new move by domestic regulators, a change that could have far-reaching implications for all oncology drugs. Previously, Fuquinitinib was seen as a potentially effective treatment option for patients with stomach cancer. Gastric cancer is the fifth most common cancer in the world, with a high incidence in China and a large patient population. With the continuous progress of precision medicine, PD-1 combined chemotherapy has become a new standard of first-line treatment for advanced gastric cancer. However, both nationally and globally, the treatment options available for patients with second-line and above treatment options remain limited. The world's major pharmaceutical companies have invested a lot of research resources in this field, promoting a variety of drugs, including PD-1, ADC, VEGFR inhibitors, etc., to enter clinical trials. VEGFR inhibitors play a key role in inhibiting tumor angiogenesis, and previous studies have shown that there are often high levels of VEGF expression in gastric cancer tissues, which is associated with advanced stages of the disease and poor prognosis. Lilly's VEGFR2 monoclonal antibody Ramoxiumab combined with paclitaxel has become the standard second-line chemotherapy regimen for advanced gastric cancer (AGC). Fuquinitinib has shown promising potential as a highly selective oral inhibitor of VEGFR-1, 2, and 3 in Phase III studies. In the FRUTIGA Phase III study, Fuquinitinib combined with paclitaxel was used as a second-line treatment in 703 patients with advanced gastric or gastroesophageal junction adenocarcinoma. The results showed that the median progression-free survival (PFS) was 5.6 months in patients treated with fuquintinib plus paclitaxel, compared with 2.7 months in patients treated with paclitaxel alone (HR=0.569, p < 0.0001). Overall survival (OS) also improved, at 9.6 versus 8.4 months, although the difference was not statistically significant. In terms of safety, the safety characteristics of fuquinitinib were consistent with previous studies, and no new safety problems were found. Clearly, the FRUTIGA Phase III study confirmed that the combination of fuquintinib and paclitaxel significantly prolonged PFS in patients compared to paclitaxel monotherapy. In addition, the objective response rate (ORR, 42.5% vs. 22.4%), disease control rate (DCR, 77.2% vs. 56.3%) and median duration of response (mDoR, 5.5 months vs. 3.7 months) in the combination treatment group were significantly better than those in the paclitaxel monotherapy group. At the ASCO Congress, HUTCHMED presented further analysis of key subgroups in FRUTIGA's Phase III study, showing that PFS and OS results were consistent with those of the intended treatment population. The combination of fuquinitinib and paclitaxel showed a clear PFS benefit in most subgroups, especially in the enteric subgroup and the lymph node metastasis subgroup, where the benefits of PFS and OS were particularly significant. In clinical design, PFS and OS are used as double primary endpoints, alpha resolution and circulation. Studies are considered positive when at least one endpoint reaches statistical significance. Nevertheless, HUTCHMED believes that despite not meeting the OS endpoint, the available clinical data and findings are sufficient to support the combination of fuquinitinib and paclitaxel as a new treatment option for second-line patients with gastric cancer, and had filed a marketing application last year. However, the CDE rejected the application for fuquitinib. HUTCHMED noted that although the higher and uneven proportion of patients receiving subsequent antitumor therapy (20% higher in the paclitaxel monotherapy group than in the combination group) may have influenced OS results, fuquinitinib combined with paclitaxel demonstrated meaningful clinical benefits and favorable OS trends across a range of models. However, the CDE does not agree with this understanding of the OS results, arguing that the available data are not yet sufficient to support marketing applications for new indications and that further research is needed. In other words, CDE expects to see more and more favorable OS data. The CDE's rigorous scrutiny of OS data is justified because overall survival data is critical for evaluating the clinical effectiveness of cancer treatments, and it directly reflects how long patients survive after receiving treatment. Based on international experience, the FDA has in the past allowed progression-free survival as a primary endpoint to provide a path to accelerated approval for drugs to market. But in the past two years, there has been a marked shift in the FDA's regulatory attitude. A batch of drugs, including ibrutinib, are voluntarily withdrawn from the market or the indication is withdrawn under the guidance of the FDA due to confirmatory clinical data failing to meet expectations, or large side effects, or limited overall survival benefits; For some new drug/new indication applications, the FDA has also begun to review OS data. At the heart of the FDA's change of heart is the fact that while some oncology drugs are marketed with alternative endpoints such as progression-free survival or objective response rates, they ultimately fail to equate these alternative endpoints with the gold standard of OS. As a result, the FDA is increasingly looking to companies to provide reliable OS data to prove that new therapies really help patients live longer. The FDA's change did not come in the form of draft guidance, but was communicated to drug companies through meetings, articles and comments from the agency's top oncologists. The CDE of cefuroxime quetiapine for the "stop", may be the beginning of a new trend. What impact this will have on cancer drug development is worth further observation.

Phase 3Clinical ResultAccelerated ApprovalNDA

02 Aug 2024

·www.echemi.com

Unexpected Setback in Rare Disease Drug Development: Takeaways from Takeda's Phase 3 Trial Failure

Recently, a well-known global takeda pharmaceuticals in its latest financial report revealed a regrettable news, which is developing the rare disease drug Soticlestat on two kinds of rare and refractory epilepsy type - and Lennox - Gastaut Dravet syndrome syndrome (LGS) the key phase III clinical trial, Failed to reach the expected effect of main goal. The results will undoubtedly bring takeda pharmaceuticals of new drug research and development of the road for a certain amount of uncertainty. Soticlestat has shown promising therapeutic potential and safety in early phase II trials, but the results of phase III trials have failed to replicate these positive signs. In SKYLINE test for Dravet syndrome patients, Soticlestat failed to significantly reduce the frequency of seizure epilepsy seizures, although in some secondary efficacy on indicators are still showing a certain clinical significance. In the SKYWAY trial, Soticlestat similarly did not significantly reduce the frequency of major motor drop seizures in patients with LGS. Takeda was undeterred by the results, which did not meet expectations. Company said that their potential indications of Soticlestat Dravet remained cautious optimism, with regulators and plan discussed in the complete clinical data, to determine the next step development strategy. However, Soticlestat accumulated hundreds of millions of dollars of losses in the process of r&d, undoubtedly has brought the financial position of the takeda extra pressure. Despite the challenges, Takeda's overall performance in the first quarter of fiscal 2021 remained strong. In the digestive tract tumor and rare diseases in the field of core product sales continue to maintain strong growth, new drug cefuroxime quetiapine for his excellent performance in the us market also has injected new vitality to the company's financial performance. These positive factors to make the industry for the future of takeda pharmaceuticals revenues and profits return to growth remain optimistic expectations. For the frustrations of takeda pharmaceuticals in the Soticlestat test, we should be more understanding and tolerant attitude to look at. New drug research and development is a challenging process, even if is the industry leader is also hard to avoid failure. Is the key to the company how to draw experience from this setback, with more the spirit of perseverance and innovation to promote the future development plan, in order to bring more treatment options for patients with global.

Phase 3Phase 2Financial StatementClinical Trial FailureNDA

22 Jul 2024

·firstwordpharma.com

J&J seeks monotherapy nod for Spravato in resistant depression

Johnson & Johnson said Monday that it filed an application to the FDA to broaden the label of Spravato (esketamine) nasal spray to include monotherapy in adult patients with treatment-resistant depression (TRD). If approved, that would position Spravato as the first standalone therapy for this challenging subset of depression patients.The NMDA receptor agonist was initially approved in 2019 in the US and Europe to treat TRD in combination with an oral antidepressant, and was later also cleared by the FDA to treat depressive symptoms in adults with acute suicidal ideation or behaviour.The new filing is supported by positive results from the Phase IV TRD4005 study, which showed rapid improvement in depressive symptoms based on the Montgomery-Åsberg Depression Rating Scale (MADRS), seen as early as 24 hours after the first dose and sustained through at least four weeks of treatment. J&J said the safety profile of Spravato monotherapy was consistent with existing clinical data for its use in combination with an oral antidepressant. No new safety signals emerged."Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don't effectively resolve their symptoms," said Bill Martin, J&J's global therapeutic area head for neuroscience. "[We]…look forward to working with the FDA to bring this innovative treatment to patients as a monotherapy option."The new filing builds on Spravato's growing commercial success. In 2023, the drug generated sales of $689 million, marking an 84% increase from the previous year. If approved as monotherapy, the drug could offer a new option for the nearly 30% of 280 million people worldwide living with major depressive disorder who have TRD, which occurs when there is an inadequate response to two or more oral antidepressants during the same depressive episode.Spravato's potential expansion as a monotherapy comes on the heels of positive results from the Phase III ESCAPE-TRD trial, reported in November. That study compared Spravato to quetiapine XR, both in combination with continuing antidepressant therapy, in adults with TRD. Spravato demonstrated superiority in achieving remission after 8 weeks, with just over 27% of recipients reaching remission compared to about 18% in the quetiapine XR arm.

Clinical ResultDrug ApprovalPhase 3

100 Deals associated with Quetiapine Fumarate

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KEGG	Wiki	ATC	Drug Bank
D00458	Quetiapine Fumarate	N05AH04	DB01224

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Bipolar and Related Disorders	JP	Kyowa Pharmaceutical Industry Co., Ltd.	03 Jul 2017
Bipolar I disorder	US	Intellipharmaceutics International, Inc.	09 May 2017
Bipolar I disorder	US	Endo Operations Ltd.	09 May 2017
Bipolar I disorder	US	PharmaDax Inc.	09 May 2017
Bipolar II disorder	US	Endo Operations Ltd.	09 May 2017
Bipolar II disorder	US	PharmaDax Inc.	09 May 2017
Depressive Disorder	US	PharmaDax Inc.	09 May 2017
Depressive Disorder	US	Intellipharmaceutics International, Inc.	09 May 2017
Depressive Disorder, Major	US	AstraZeneca UK Ltd.	02 Dec 2009
Bipolar Disorder	US	AstraZeneca Pharmaceuticals LP	26 Sep 1997
Schizophrenia	US	AstraZeneca Pharmaceuticals LP	26 Sep 1997

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Marijuana Abuse	Phase 3	DE	AstraZeneca PLC	01 Sep 2009
Depressive Disorder, Treatment-Resistant	Phase 3	AU	AstraZeneca PLC	01 Nov 2008
Depressive Disorder, Treatment-Resistant	Phase 3	AT	AstraZeneca PLC	01 Nov 2008
Depressive Disorder, Treatment-Resistant	Phase 3	BE	AstraZeneca PLC	01 Nov 2008
Depressive Disorder, Treatment-Resistant	Phase 3	BG	AstraZeneca PLC	01 Nov 2008
Depressive Disorder, Treatment-Resistant	Phase 3	DK	AstraZeneca PLC	01 Nov 2008
Depressive Disorder, Treatment-Resistant	Phase 3	DE	AstraZeneca PLC	01 Nov 2008
Depressive Disorder, Treatment-Resistant	Phase 3	HU	AstraZeneca PLC	01 Nov 2008
Depressive Disorder, Treatment-Resistant	Phase 3	IT	AstraZeneca PLC	01 Nov 2008
Depressive Disorder, Treatment-Resistant	Phase 3	PT	AstraZeneca PLC	01 Nov 2008

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


FRI662 (ENDO2023)	Not Applicable	Hypoglycemia	-	Quetiapine	wnllkcwcdi(iefickcmuj) = Severe hypoglycemia from treatment with quetiapine ijxmdazlge (tawegsjcbo )	Positive	05 Oct 2023
				Glucagon
NCT01858948 (CTgov)	Phase 3	Metabolic Syndrome \| Bipolar Disorder	19	Placebo+Quetiapine fumarate	hwednjxtkk(sdtutfhcjr) = fkevenjdco lukswntnun (vauncuwwdn, bduzeljpab - obdehzzhti) View more	-	25 Nov 2022
NCT02845453 (CTgov)	Phase 4	Bipolar Disorder \| Substance Abuse	24	Quetiapine (Quetiapine)	juwbdreltk(bhmkdfvwdh) = maisybaunv kboemjrfmo (uedznyjbiv, bngjihhbfj - qdlwhhxaab) View more	-	18 Apr 2022
				Placebo (Placebo)	juwbdreltk(bhmkdfvwdh) = hccebhtzzi kboemjrfmo (uedznyjbiv, epohircqso - orrzshtfau) View more
NCT00688818 (Pubmed \| J Clin Psychiatry)	Not Applicable	Depressive Disorder \| Anxiety Disorders Add-on	76	Quetiapine XR	fvsexeldxl(zlidrexnfn) = vxyusyonzp jmaqltkfkp (zjeumzxkqm, -7.41 to -0.64) View more	Positive	21 Mar 2022
NCT03568500 (CTgov)	Phase 4	Schizoaffective disorder \| Schizophrenia	44	Digital Medicine System+Aripiprazole (Aripiprazole)	wtdxmbrneu(bafrizmusc) = uigfnrawvi xrbbjsymon (wkippfzkrd, ilvesiwovh - nsrctafmgr) View more	-	16 Jul 2020
				Digital Medicine System+Olanzapine (Olanzapine)	wtdxmbrneu(bafrizmusc) = gcyjeojqlc xrbbjsymon (wkippfzkrd, qonwxffubo - tpgxjzbphy) View more
NCT00579280 (CTgov)	Phase 4	Bipolar Disorder \| Panic \| Panic Disorder ... View more	224	quetiapine SR (Quetiapine SR)	zavnehrcwj(jccrnvxkgu) = ilgfcnafga uhijmlrlyq (neqadksxjn, mjdpnzvkys - zddgrdcmkz) View more	-	11 Jun 2020
				divalproex sodium ER (Divalproex Sodium ER)	zavnehrcwj(jccrnvxkgu) = oqsadgmgpa uhijmlrlyq (neqadksxjn, ywychqypwa - izcuirfelq) View more
NCT00515723 (Glulipid, CTgov)	Not Applicable	Diabetes Mellitus, Type 2 \| Schizoaffective disorder \| Schizophrenia ... View more	96	olanzapine (Olanzapine)	kawcbnxabq(xtxmcyuuug) = xowwaawque jyiuamzpot (etsrknygly, mbqoqehthj - rmkqfvgxfx) View more	-	02 Oct 2019
				risperidone (Risperidone)	kawcbnxabq(xtxmcyuuug) = ryjwwmfytc jyiuamzpot (etsrknygly, tyxdvktylk - mpiipdpkzl) View more
NCT00269399 (CTgov)	Phase 3	Clostridium difficile diarrhea \| Diarrhea \| Clostridium Infections	237	Rifaximin (Xifaxan) (Rifaximin Treatment Arm)	fqjxyqmjnw(bcagmeasvo) = rbjyfyrjzr uluzlrbwnj (kygpctczlj, eoghnmjaap - bfxlpfcuxc) View more	-	01 Oct 2019
				Vancomycin (Vancomycin Comparator Arm)	fqjxyqmjnw(bcagmeasvo) = cfanqiknlh uluzlrbwnj (kygpctczlj, wvxthyleoe - jmaprrnlte) View more
NCT00518973 (CTgov)	Not Applicable	Anorexia Nervosa	21	Placebo (Placebo)	kuqbmhlvzx(johppurevo) = kcftvgbymm vbzafnidjq (mznyzkhomi, khemiupmvu - iwamnbvisn) View more	-	17 Jul 2019
				Quetiapine (Quetiapine)	kuqbmhlvzx(johppurevo) = dlxcrfxnxu vbzafnidjq (mznyzkhomi, ahjdhxesrv - hyjfrpjnxo) View more
NCT00457366 (CTgov)	Phase 4	Agitation	72	Quetiapine	gzhpzqvwwn(uqqrufdwku) = efbfwohdlu xhtsfuzzix (cbtwijwcqf, gpqipmxhfz - uxbilyjxuh) View more	-	05 Jul 2019

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