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Disease

Major depressive disorder

Late-stage therapeutic development
Also known as MDD, major depression, major depressive disorder and accelerated response to antidepressant drug treatment, major depressive disorder, response to citalopram therapy in+6 more

MDD, major depression, major depressive disorder and accelerated response to antidepressant drug treatment, major depressive disorder, response to citalopram therapy in, recurrent major depression, single major depressive episode, unipolar depression, unipolar depression, susceptibility to, major depressive disorder 1, major depressive disorder 2.

24
Clinical trials
12
Associated genes
12
Related proteins
Current focus
5-hydroxytryptamine 2a biologyD(2) dopamine biologyTherapeutic development
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this disease.

Approval: Cymbalta (EMA)

Regulatory2004-12-17EMA

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Moderate
Key developments
  • 6 clinical trials expected to report results, the earliest in Q3 2028.
  • 1 industry development reported.
Upcoming Milestones
Clinical Milestones15View all 15
Results expected 5
Recently completed 5
Other updates 3
+7 more in the activity timeline below
Industry & Market1View
Activity timeline16

Therapeutic landscape

Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.

Approved & established therapies
Esketamine hydrochlorideapproved

Approval — Spravato, in combination with a SSRI or SNRI, is indicated for adults with treatment-resi… (2019)

Duloxetineapproved

Approval — Treatment of major depressive disorder Treatment of diabetic peripheral neuropathic pain… (2015)

Clinical trials

16 sponsors · 7 new · 6 completed in the last 12 months (net +6)

The current development programme across all trial phases.

Clinical programme
24
All trials
6
Active
18
Late-stage
6
Completed
Late-stage studies

A Double-blind, Randomized, Psychoactive Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine 84 mg in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder in Adolescent Participants With Acute Suicidal Ideation or Behavior

Phase 3 · Recruiting · Janssen Research & Development, LLC

RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE)

Phase 4 · Recruiting · Mayo Clinic

Prefrontal Glutamatergic Modulation by N-acetylcysteine and Mindfulness-based Cognitive Therapy for Mild Depression in Youth

Phase 3 · Recruiting · University of Cincinnati

Sequential Multiple Assignment Randomized Trial for Bipolar Depression

Phase 4 · Active, not recruiting · Massachusetts General Hospital

A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Study of Solriamfetol in Subjects With Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms

Phase 3 · Recruiting · Axsome Therapeutics, Inc.

A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate Efficacy and Safety of Seltorexant as Monotherapy in Adult and Elderly Participants With Major Depressive Disorder (MDD) and an Open-label Long-term Extension Treatment With Seltorexant

Phase 3 · Recruiting · Janssen Research & Development, LLC
Recruiting

A Double-blind, Randomized, Psychoactive Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine 84 mg in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder in Adolescent Participants With Acute Suicidal Ideation or Behavior

Phase 3 · Recruiting · Janssen Research & Development, LLC

RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE)

Phase 4 · Recruiting · Mayo Clinic

Prefrontal Glutamatergic Modulation by N-acetylcysteine and Mindfulness-based Cognitive Therapy for Mild Depression in Youth

Phase 3 · Recruiting · University of Cincinnati

A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Study of Solriamfetol in Subjects With Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms

Phase 3 · Recruiting · Axsome Therapeutics, Inc.

A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate Efficacy and Safety of Seltorexant as Monotherapy in Adult and Elderly Participants With Major Depressive Disorder (MDD) and an Open-label Long-term Extension Treatment With Seltorexant

Phase 3 · Recruiting · Janssen Research & Development, LLC
Recently completed

Clonidine to Prevent Postictal Delirium After ElectroConvulsive Therapy: a Randomised, Placebo-controlled, Triple-blind, Single-centre Trial.

Phase 4 · Completed · Insel Gruppe AG, University Hospital Bern

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Oral NMRA-335140 Versus Placebo in Participants With Major Depressive Disorder

Phase 3 · Completed · Neumora Therapeutics, Inc.

Research on the Therapeutic Effect and Clinical Indicators of XingpiJieyu Formula in the Treatment of Severe Liver Depression and Spleen Deficiency Type Depression Based on Abnormal Mitochondrial Energy Metabolism Pathway

Phase 4 · Completed · Peking University Sixth Hospital

Neurocomputational Mechanisms of Mood Improvement

Phase 4 · Completed · Marta Peciña, MD PhD

A Randomized, Blinded, Placebo-Controlled Study to Evaluate the Saftey and Efficacy of Oral LPCN 1154A in Women With Postpartum Depression

Phase 3 · Completed · Lipocine Inc.

Long-term Efficacy and Tolerability of add-on Pramipexole for Anhedonic Depression - an Open Label Follow-up Study

Phase 3 · Completed · Region Skane

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

First approvals
2019emaApproval — Esketamine hydrochloride· Spravato, in combination with a SSRI or SNRI, is indicated for adults with treatment-resistant Major Depressive Disorder, who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode. source ↗
2015emaApproval — Duloxetine· Treatment of major depressive disorder Treatment of diabetic peripheral neuropathic pain Treatment of generalised anxiety disorder Duloxetine Viatris is indicated in adults source ↗
2014emaApproval — Duloxetine· Duloxetine Lilly is indicated in adults for: Treatment of major depressive disorder Treatment of diabetic peripheral neuropathic pain Treatment of generalised anxiety disorder Duloxetine Lilly is indicated in adults. source ↗
2004emaApproval — Duloxetine· Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder. Cymbalta is indicated in adults. source ↗

European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.

Associated genes

12 matches

Genes associated with this disease in the canonical knowledge graph (Open Targets evidence). Number shows the association score.

DRD20.74HTR2A0.70GABRA10.67GRIN2A0.66SLC6A40.64HTR1A0.63SLC6A30.63SLC6A20.62GABRB10.62SCN11A0.62GABRA60.61DRD30.61

Disease biology

12 matches

Proteins whose encoding gene is associated with this disease, reached through the canonical gene→disease graph. Number shows the gene's association score.

D(2) dopamine receptorvia DRD20.745-hydroxytryptamine receptor 2Avia HTR2A0.70Gamma-aminobutyric acid receptor subunit alpha-1via GABRA10.67Glutamate receptor ionotropic, NMDA 2Avia GRIN2A0.66Sodium-dependent serotonin transportervia SLC6A40.645-hydroxytryptamine receptor 1Avia HTR1A0.63Sodium-dependent dopamine transportervia SLC6A30.63Sodium-dependent noradrenaline transportervia SLC6A20.62Gamma-aminobutyric acid receptor subunit beta-1via GABRB10.62Sodium channel protein type 11 subunit alphavia SCN11A0.62Gamma-aminobutyric acid receptor subunit alpha-6via GABRA60.61D(3) dopamine receptorvia DRD30.61

Reference

Authoritative identity, definition & identifiers.

Synonyms

MDD, major depression, major depressive disorder and accelerated response to antidepressant drug treatment, major depressive disorder, response to citalopram therapy in, recurrent major depression, single major depressive episode, unipolar depression, unipolar depression, susceptibility to, major depressive disorder 1, major depressive disorder 2

References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.