A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)
- Conditions
- Major Depressive Disorder
- Interventions
- Drug: ALKS 5461 Placebo
- Registration Number
- NCT03188185
- Lead Sponsor
- Alkermes, Inc.
- Brief Summary
This study will evaluate the efficacy, safety, and tolerability of adjunctive ALKS 5461 in adults who have treatment refractory MDD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 278
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ALKS 5461 Placebo ALKS 5461 Placebo Sublingual tablets ALKS 5461 ALKS 5461 Sublingual tablets
- Primary Outcome Measures
Name Time Method Change From Baseline to the End of Treatment (EOT) in the Montgomery Asberg Depression Rating Scale-10 (MADRS-10) Scores 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.
- Secondary Outcome Measures
Name Time Method Montgomery Asberg Depression Rating Scale (MADRS) Remission Rate 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.
Montgomery Asberg Depression Rating Scale (MADRS) Response Rate 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).
Trial Locations
- Locations (2)
Alkermes Investigational Site
🇵🇷San Juan, Puerto Rico
Alkermes Investigative Site
🇺🇸Bellevue, Washington, United States