Summary
Quetiapine Fumarate has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Major Depressive Disorder would be drug repurposing rather than first-in-human development. This does not mean it is approved for Major Depressive Disorder. ClinicalTrials.gov lists 8 registered trials linking Quetiapine Fumarate to Major Depressive Disorder: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01305707). The largest enrolment is 800 participants (NCT01795326). Registration activity spans 2006 to 2017. The literature layer holds 5 publications for this pair: 5 clinical trial publications. Publication years run from 2014 to 2015. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
The RepurpOS disease-intelligence file for Major Depressive Disorder ranks 580 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Relapse in 19-45% within 1 year of antidepressant discontinuation after remission; relapse risk ratio (off-medication vs on) falls from 3.69x at 2 months to 1.34x at 5 years.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 60.0 (trials 30.0, literature 10.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 6 completed, 2 other |
| Linked publications | 5 (5 clinical trial publications) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT00892463 | Identifying Very Early Response to Seroquel Extended Release (XR) Augmentation for Major Depressive Disorder 2009 | completed | Phase 4 | 26 |
| NCT01305707 | Continuation Electroconvulsive Therapy (C-ECT) for Relapse Prevention in Major Depression 2009 | terminated | Phase 4 | 104 |
| NCT00955474 | Seroquel Alone Versus Seroquel With an SSRI for Depression With Psychotic Symptoms 2008 | terminated | Phase 4 | 32 |
| NCT00388973 | Efficacy and Safety Study of Seroquel SR in the Treatment of Major Depressive Disorder 2006 | completed | Phase 3 | 338 |
| NCT00321490 | Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo and Active Control in Major Depressive Disorder 2006 | completed | Phase 3 | 600 |
| NCT02720198 | Levomilnacipran ER vs. Adjunctive Quetiapine for Adults With Inadequate Relief With SSRIs in MDD 2017 | completed | Phase 3 | 60 |
| NCT00320268 | Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo in Major Depressive Disorder 2006 | completed | Phase 3 | 600 |
| NCT01795326 | Physician Survey on Monitoring of Patients Treated With Quetiapine 2013 | completed | Not applicable | 800 |
Published literature
- Clinical trial publication Analysis of potentially predictive factors of efficacy of adjunct extended-release quetiapine fumarate in patients with major depressive disorderBauer M, Thase ME, Liu S et al. · Journal of psychopharmacology (Oxford, England) · 2015 · PMID 25257148
- Clinical trial publication The influence of Hatha yoga as an add-on treatment in major depression on hypothalamic-pituitary-adrenal-axis activity: a randomized trialSarubin N, Nothdurfter C, Schüle C et al. · Journal of psychiatric research · 2014 · PMID 24655586
- Clinical trial publication Extended release quetiapine fumarate as adjunct to antidepressant therapy in patients with major depressive disorder: pooled analyses of data in patients with anxious depression versus low levels of anxiety at baselineBandelow B, Bauer M, Vieta E et al. · The world journal of biological psychiatry : the official journal of the World Federation of Societies of Biological Psychiatry · 2014 · PMID 24506289
- Clinical trial publication Quetiapine fumarate extended-release for the treatment of major depression with comorbid fibromyalgia syndrome: a double-blind, randomized, placebo-controlled studyMcIntyre A, Paisley D, Kouassi E et al. · Arthritis & rheumatology (Hoboken, N.J.) · 2014 · PMID 24504819
- Clinical trial publication Impact on cortisol and antidepressant efficacy of quetiapine and escitalopram in depressionSarubin N, Nothdurfter C, Schmotz C et al. · Psychoneuroendocrinology · 2014 · PMID 24275013
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Quetiapine Fumarate approved for Major Depressive Disorder?
Quetiapine Fumarate has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Major Depressive Disorder would be drug repurposing rather than first-in-human development. This does not mean it is approved for Major Depressive Disorder. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Quetiapine Fumarate in clinical trials for Major Depressive Disorder?
ClinicalTrials.gov lists 8 registered trials linking Quetiapine Fumarate to Major Depressive Disorder: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01305707). The largest enrolment is 800 participants (NCT01795326). Registration activity spans 2006 to 2017.
What does the evidence show for Quetiapine Fumarate in Major Depressive Disorder?
Quetiapine Fumarate has 6 completed trials and 5 linked publications for Major Depressive Disorder. Completed trials may or may not have posted results; follow the NCT links to check. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.