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

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ClinicalTrials.gov Identifier: NCT03188185
Recruitment Status : Recruiting
First Posted : June 15, 2017
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: ALKS 5461 Drug: ALKS 5461 Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3b Efficacy and Safety Study of Adjunctive ALKS 5461 in Treatment Refractory Major Depressive Disorder
Actual Study Start Date : June 12, 2017
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ALKS 5461
Sublingual tablets
Drug: ALKS 5461
Samidorphan + buprenorphine, administered sublingually

Placebo Comparator: ALKS 5461 Placebo
Sublingual tablets
Drug: ALKS 5461 Placebo
Placebo tablet, administered sublingually




Primary Outcome Measures :
  1. Change from baseline in the Montgomery Asberg Depression Rating Scale (MADRS) scores [ Time Frame: 11 weeks ]

Secondary Outcome Measures :
  1. MADRS response [ Time Frame: 11 weeks ]
    >/= 50% reduction in MADRS score

  2. MADRS remission [ Time Frame: 11 weeks ]
    MADRS score </= 10


Other Outcome Measures:
  1. Improvement in emotional resiliency [ Time Frame: 11 weeks ]
    Change from baseline in Connor-Davidson Resilience Scale (CD-RISC-25) scores

  2. Reduction in emotional blunting [ Time Frame: 11 weeks ]
    Change from baseline in Snaith-Hamilton Pleasure Scale (SHAPS) scores

  3. Improvement in pain [ Time Frame: 11 weeks ]
    Change from baseline in Brief Pain Inventory-Short Form (BPI-SF) scores

  4. Safety will be measured by frequency of serious and non-serious adverse events [ Time Frame: 12 weeks ]
  5. Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 12 weeks ]
  6. Mean change from baseline in Clinical Opiate Withdrawal Scale (COWS) scores [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03188185


Contacts
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Contact: Jean-Francois Gagne 919-257-6569 Jean-Francois.Gagne@INCResearch.com

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Sponsors and Collaborators
Alkermes, Inc.
Investigators
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Study Director: Sanjeev Pathak, MD Alkermes, Inc.

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Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT03188185     History of Changes
Other Study ID Numbers: ALK5461-217
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alkermes, Inc.:
Alkermes
Major Depressive Disorder
Treatment Refractory MDD
ALKS 5461

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Disease
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Buprenorphine
Naltrexone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Alcohol Deterrents