Phase 3
N=278
A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03188185 ↗Enrolled (actual)
278
Serious AEs
0.5%
Results posted
Mar 2021
Primary outcome: Primary: Change From Baseline to the End of Treatment (EOT) in the Montgomery Asberg Depression Rating Scale-10 (MADRS-10) Scores — -11.4; -13.9; -4.2; -4.7 score on a scale — p=0.128
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ALKS 5461 (Drug); ALKS 5461 Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alkermes, Inc.
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to the End of Treatment (EOT) in the Montgomery Asberg Depression Rating Scale-10 (MADRS-10) Scores |
-11.4; -13.9; -4.2; -4.7 | 0.128 |
| SECONDARY Montgomery Asberg Depression Rating Scale (MADRS) Response Rate |
53; 27; 10; 11; 142; 49 | — |
| SECONDARY Montgomery Asberg Depression Rating Scale (MADRS) Remission Rate |
31; 14; 10; 8; 164; 62 | — |
Summary
This study will evaluate the efficacy, safety, and tolerability of adjunctive ALKS 5461 in adults who have treatment refractory MDD.
Eligibility Criteria
Inclusion Criteria
- Have a Major Depressive Disorder (MDD) primary diagnosis
- Have a body mass index (BMI) of 18.0 to </= 40.0 kg/m^2
- Be willing and able to follow the study procedures and visits as outlined in the protocol (including agreeing not to enroll in any other clinical trials)
- Have inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
- Additional criteria may apply
Exclusion Criteria
- Has any finding that would compromise the safety of the subject or affect their ability to adhere to the protocol visit schedule or fulfill visit requirements
- Has any other significant medical condition (eg, neurological, psychiatric, or metabolic) or clinical symptom that could unduly risk the subject or affect the interpretation of study data
- Has any current primary diagnosis other than MDD, where primary diagnosis is defined as the primary source of current distress and functional impairment
- Has experienced hallucinations, delusions, or any psychotic symptoms in the current MDE
- Has been hospitalized for MDD within 3 months before screening
- Has used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days prior to screening
- Has received electroconvulsive therapy treatment within the last 2 years or within the current MDE or failed a course of electroconvulsive treatment at any time
- Has a significant risk for suicide
- Has a positive breath alcohol test at screening
- Has a positive test for drugs of abuse at screening or visit 2
- Is pregnant, planning to become pregnant, or is breastfeeding during the study
- Additional criteria may apply
Data sourced from ClinicalTrials.gov (NCT03188185). 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.