Summary
Sertraline Hydrochloride 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 Sertraline Hydrochloride to Major Depressive Disorder: 3 are currently recruiting; 3 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00519012). The largest enrolment is 26376 participants (NCT07015944). Registration activity spans 2001 to 2025. The literature layer holds 5 publications for this pair: 5 clinical trial publications. Publication years run from 2008 to 2020. 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: 3 recruiting, 0 active / not yet recruiting, 3 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00177996 | Pharmacotherapy in Depression With Panic Spectrum 2001 | completed | Phase 4 | 30 |
| NCT07478796 | TDM-Guided Treatment With SSRIs in Hospitalized Adults and Children 2025 | recruiting | Phase 4 | 180 |
| NCT00519012 | Benefits of Switching Antidepressants Following Early Nonresponse 2007 | status unknown | Phase 4 | 200 |
| NCT01838876 | Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder 2013 | completed | Phase 3 | 442 |
| NCT00174590 | Treatment of Major Depressive Disorder With Psychotic Features. 2001 | terminated | Phase 3 | 30 |
| NCT00275197 | A Research Study to Compare the Treatments of a Combination of Elzasonan With Zoloft, to Zoloft Alone, or Placebo in People With Major Depressive Disorder (MDD) 2005 | completed | Phase 2 | 262 |
| NCT05002309 | Treatment Interrupts Depression Early 2021 | recruiting | Phase 2 | 100 |
| NCT07015944 | Moving on After Breast Cancer Trial for Depressed Breast Cancer Survivors in Pakistan 2025 | recruiting | Not applicable | 26,376 |
Published literature
- Clinical trial publication Evaluation of a Machine Learning Model Based on Pretreatment Symptoms and Electroencephalographic Features to Predict Outcomes of Antidepressant Treatment in Adults With Depression: A Prespecified Secondary Analysis of a Randomized Clinical TrialRajpurkar P, Yang J, Dass N et al. · JAMA network open · 2020 · PMID 32568399
- Clinical trial publication Cortical Connectivity Moderators of Antidepressant vs Placebo Treatment Response in Major Depressive Disorder: Secondary Analysis of a Randomized Clinical TrialRolle CE, Fonzo GA, Wu W et al. · JAMA psychiatry · 2020 · PMID 31895437
- Clinical trial publication Pretreatment Rostral Anterior Cingulate Cortex Theta Activity in Relation to Symptom Improvement in Depression: A Randomized Clinical TrialPizzagalli DA, Webb CA, Dillon DG et al. · JAMA psychiatry · 2018 · PMID 29641834
- Clinical trial publication The sertraline vs. electrical current therapy for treating depression clinical study: results from a factorial, randomized, controlled trialBrunoni AR, Valiengo L, Baccaro A et al. · JAMA psychiatry · 2013 · PMID 23389323
- Clinical trial publication Selecting among second-step antidepressant medication monotherapies: predictive value of clinical, demographic, or first-step treatment featuresRush AJ, Wisniewski SR, Warden D et al. · Archives of general psychiatry · 2008 · PMID 18678792
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 Sertraline Hydrochloride approved for Major Depressive Disorder?
Sertraline Hydrochloride 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 Sertraline Hydrochloride in clinical trials for Major Depressive Disorder?
ClinicalTrials.gov lists 8 registered trials linking Sertraline Hydrochloride to Major Depressive Disorder: 3 are currently recruiting; 3 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00519012). The largest enrolment is 26376 participants (NCT07015944). Registration activity spans 2001 to 2025.
What does the evidence show for Sertraline Hydrochloride in Major Depressive Disorder?
Sertraline Hydrochloride has 3 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.