Phase 2
N=141
A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01500200 ↗Enrolled (actual)
141
Serious AEs
1.5%
Results posted
May 2019
Primary outcome: Primary: Change From Baseline to Week 4 in Hamilton Rating Scale for Depression (HAM-D17) Total Score — -7.1; -9.3; -6.6; -1.5 score on a scale — p=0.014
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ALKS 5461 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alkermes, Inc.
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 4 in Hamilton Rating Scale for Depression (HAM-D17) Total Score |
-7.1; -9.3; -6.6; -1.5; -5.2; -3.3 | 0.014 sig |
| SECONDARY Proportion of Patients Who Exhibited Treatment Response (HAM-D17) |
23; 8; 5; 3; 6; 5 | — |
| SECONDARY Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score |
-9.6; -13.3; -11.3; -2.1; -8.8; -4.7 | — |
| SECONDARY Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score |
-1.0; -1.3; -1.2; -0.5; -1.1; -0.6 | — |
Summary
This study will evaluate the efficacy of ALKS 5461 when administered daily for 4 weeks to adults with Major Depressive Disorder (MDD) and inadequate response to antidepressant therapy.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with a major depressive episode (MDE)
- Body mass index less than or equal to 40 kg/m2
- Have been treated with an adequate dose of SSRI/SNRI during the current MDE for at least 8 weeks, with the same, adequate dose over the last 4 weeks that is expected to remain stable throughout the study
- History of inadequate response during the entire current MDE to 1 or 2 adequate antidepressant treatments, including current treatment
- Be otherwise physically healthy
Exclusion Criteria
- Have an axis I diagnosis of delirium, dementia, amnestic or other cognitive disorder, schizophrenia or other psychotic disorder, bipolar I or II disorder, eating disorder, obsessive-compulsive disorder, panic disorder, acute stress disorder, or posttraumatic stress disorder
- Have a clinically significant current axis II diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder
- Are experiencing hallucinations, delusions, or any psychotic symptomatology in the current MDE
- Receive new onset psychotherapy within 6 weeks of screening
- Use of opioid agonists (eg, codeine, oxycodone, morphine) within 14 days before screening
- Have received electroconvulsive therapy during the current MDE
- Have attempted suicide within the past 2 years
- Have a thyroid pathology
- Have a history of a seizure disorder or of neuroleptic malignant syndrome/serotonin syndrome
- Have a positive test for human immunodeficiency virus (HIV)
Additional inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01500200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.