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Completed

NCT Number: NCT03188185

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

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

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alkermes Investigational Site, Frankston, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALKS 5461

Drug

Samidorphan + buprenorphine, administered sublingually

ALKS 5461 Placebo

Drug

Placebo tablet, administered sublingually

Primary outcomes

  1. Change From Baseline to the End of Treatment (EOT) in the Montgomery Asberg Depression Rating Scale-10 (MADRS-10) Scores

    Time frame: 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 outcomes

  1. Montgomery Asberg Depression Rating Scale (MADRS) Response Rate

    Time frame: 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).

  2. Montgomery Asberg Depression Rating Scale (MADRS) Remission Rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

A Phase 3b Efficacy and Safety Study of Adjunctive ALKS 5461 in Treatment Refractory Major Depressive Disorder

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 15, 2017
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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