NCT03188185 is a Phase 3 clinical trial of ALKS 5461 in Major Depressive Disorder, sponsored by Alkermes, Inc..

Who is sponsoring NCT03188185?

NCT03188185 is sponsored by Alkermes, Inc..

What drugs are being tested in NCT03188185?

Interventions in NCT03188185: ALKS 5461, ALKS 5461 Placebo.

What condition does NCT03188185 study?

NCT03188185 studies Major Depressive Disorder.

Is NCT03188185 still recruiting?

NCT03188185 is currently completed. Last updated 8 April 2021.

Are results published for NCT03188185?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-04-08 · How we verify

NCT03188185

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)

Completed Phase 3 Results posted Last updated 8 April 2021

What this trial tests

Phase 3 trial testing ALKS 5461 in Major Depressive Disorder in 278 participants. Completed in 5 March 2020.

Timeline

12 June 2017

Primary endpoint
26 February 2020

5 March 2020

Quick facts

Lead sponsor	Alkermes, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	278
Start date	12 June 2017
Primary completion	26 February 2020
Estimated completion	5 March 2020
Sites	35 locations across Puerto Rico, United States, Australia

Drugs / interventions tested

ALKS 5461 — full drug profile →
ALKS 5461 Placebo

Conditions studied

Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

Alkermes, Inc. — full company profile →

Who can join

Adults 18 to 70, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline to the End of Treatment (EOT) in the Montgomery Asberg Depression Rating Scale-10 (MADRS-10) Scores Primary · Baseline and 5 weeks for Stage 1, Baseline and 6 weeks for Stage 2

The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of Major Depressive Disorder (MDD) symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.

Group	Value	95% CI
S1: Placebo	-11.4	± 0.70
S1: ALKS 5461 2mg/2mg	-13.9	± 1.12
S2: Placebo	-4.2	± 1.06
S2: ALKS 5461 2mg/2mg	-4.7	± 1.11

Montgomery Asberg Depression Rating Scale (MADRS) Response Rate Secondary · Baseline and 5 weeks for Stage 1, Baseline and 6 weeks for Stage 2

The percentage of subjects demonstrating a MADRS-10 treatment response, defined as a \>/= 50% reduction in MADRS-10 score from baseline to the end of the efficacy period (Week 5 for Stage 1, Week 6 for Stage 2). The MADRS-10 scale is a measure of the severity of Major Depressive Disorder (MDD) symptoms and includes the following 10 items: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms).

Group	Value	95% CI
S1: Placebo	53
S1: ALKS 5461 2mg/2mg	27
S2: Placebo	10
S2: ALKS 5461 2mg/2mg	11
S1: Placebo	142
S1: ALKS 5461 2mg/2mg	49
S2: Placebo	54
S2: ALKS 5461 2mg/2mg	52

Montgomery Asberg Depression Rating Scale (MADRS) Remission Rate Secondary · 5 weeks for Stage 1, 6 weeks for Stage 2

The percentage of subjects achieving remission, defined as a subject with a score \</= 10 at the end of the efficacy period (Week 5 for Stage 1, Week 6 for Stage 2). The MADRS-10 scale is a measure of the severity of Major Depressive Disorder (MDD) symptoms and includes the following 10 items: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms).the end of the efficacy period.

Group	Value	95% CI
S1: Placebo	31
S1: ALKS 5461 2mg/2mg	14
S2: Placebo	10
S2: ALKS 5461 2mg/2mg	8
S1: Placebo	164
S1: ALKS 5461 2mg/2mg	62
S2: Placebo	54
S2: ALKS 5461 2mg/2mg	55

Adverse events — posted to ClinicalTrials.gov

Time frame: 5 weeks for Stage 1 and 6 weeks for Stage 2. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

S1: Placebo

Serious: 0/198 (0%)

Deaths: 0/198

S1: ALKS 5461 2mg/2mg

Serious: 1/80 (1%)

Deaths: 0/80

S2: Placebo

Serious: 1/64 (2%)

Deaths: 0/64

S2: ALKS 5461 2mg/2mg

Serious: 0/63 (0%)

Deaths: 0/63

Serious adverse events (2 terms)

Reaction	System	S1: Placebo	S1: ALKS 5461 2mg/2mg	S2: Placebo	S2: ALKS 5461 2mg/2mg
Serotonin Syndrome	Nervous system disorders	—	—	—	—
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—

Other adverse events (10 terms — click to expand)

Reaction	System	S1: Placebo	S1: ALKS 5461 2mg/2mg	S2: Placebo	S2: ALKS 5461 2mg/2mg
Nausea	Gastrointestinal disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Somnolence	Nervous system disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Sedation	Nervous system disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Abnormal dreams	Psychiatric disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—

Most-reported serious reactions: Serotonin Syndrome, Meningioma.

Data from ClinicalTrials.gov NCT03188185 adverse events section.

Sponsor's own description

This study will evaluate the efficacy, safety, and tolerability of adjunctive ALKS 5461 in adults who have treatment refractory MDD.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

The future of psychopharmacology: a critical appraisal of ongoing phase 2/3 trials, and of some current trends aiming to de-risk trial programmes of novel agents.
Correll CU, Solmi M, Cortese S, Fava M, et al · · 2023 · cited 90× · PMID 36640403 · DOI 10.1002/wps.21056
How should we design future mechanistic and/or efficacy clinical trials?
Fava M. · · 2024 · cited 14× · PMID 37237086 · DOI 10.1038/s41386-023-01600-9
Investigational Drugs for the Treatment of Depression (Part 2): Glutamatergic, Cholinergic, Sestrin Modulators, and Other Agents.
Vasiliu O. · · 2022 · cited 9× · PMID 35847011 · DOI 10.3389/fphar.2022.884155
The efficacy and safety of buprenorphine for the treatment of depression: A systematic review and meta-analysis.
Riblet NB, Young-Xu Y, Shiner B, Schnurr PP, et al · · 2023 · cited 8× · PMID 37019069 · DOI 10.1016/j.jpsychires.2023.03.037

Verify or expand the search:

Other trials of ALKS 5461

Trials testing the same drug.

NCT03610048 — A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD) · Phase 3 · terminated

Other recruiting trials for Major Depressive Disorder

Currently open trials in the same condition.

NCT07219394 — Peer-Delivered Behavioral Activation in a CCBHC · NA · recruiting
NCT06705478 — Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disor · Phase 2 · recruiting
NCT06749392 — An Individual-specific Synchrony Signature · NA · recruiting
NCT07316803 — Group Intervention for Romantic Relationships in Young Adults With Severe Mental Illness · NA · recruiting
NCT07242105 — Optimizing Brain Excitability in Depression · NA · recruiting

Other Alkermes, Inc. trials

Trials by the same sponsor.

NCT06555783 — A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2 · Phase 2 · completed
NCT06358950 — A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201) · Phase 2 · completed
NCT05547100 — Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan · Phase 1 · completed
NCT05019105 — Phase 1 ALKS 1140 in Healthy Adults · Phase 1 · terminated
NCT04987658 — Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03188185 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Alkermes, Inc.
Last refreshed: 8 April 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03188185.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing