A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)

Major Depressive Disorder Clinical Trial

Official title:

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01500200
• Other study ID #: ALK5461-202
• Status: Completed
• Phase: Phase 2
• Start date: December 2011
• Est. completion date: March 2013

Study information

• Verified date: April 2019
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study will measure efficacy using the HAM-D-17, the MADRS, and the CGI-S as well as using other scales and assessments.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• ALKS 5461
Two active tablets, given daily
• Placebo
Two placebo tablets, given daily

Locations

Country	Name	City	State
United States	Alkermes Investigational Site	Atlanta	Georgia
United States	Alkermes Investigational Site	Austin	Texas
United States	Alkermes Investigational Site	Baltimore	Maryland
United States	Alkermes Investigational Site	Bellevue	Washington
United States	Alkermes Investigational Site	Berlin	New Jersey
United States	Alkermes Investigational Site	Boston	Massachusetts
United States	Alkermes Investigational Site	Brooklyn	New York
United States	Alkermes Investigational Site	Canton	Ohio
United States	Alkermes Investigational Site	Charleston	South Carolina
United States	Alkermes Investigational Site	Dallas	Texas
United States	Alkermes Investigational Site	Dayton	Ohio
United States	Alkermes Investigational Site	Fort Myers	Florida
United States	Alkermes Investigational Site	Haverhill	Massachusetts
United States	Alkermes Investigational Site	Hoffman Estates	Illinois
United States	Alkermes Investigational Site	Houston	Texas
United States	Alkermes Investigational Site	Lauderhill	Florida
United States	Alkermes Investigational Site	Leesburg	Florida
United States	Alkermes Investigational Site	New York	New York
United States	Alkermes Investigational Site	North Miami	Florida
United States	Alkermes Investigational Site	Oceanside	California
United States	Alkermes Investigational Site	Oklahoma City	Oklahoma
United States	Alkermes Investigational Site	Philadelphia	Pennsylvania
United States	Alkermes Investigational Site	Saint Petersburg	Florida
United States	Alkermes Investigational Site	San Antonio	Texas
United States	Alkermes Investigational Site	Santa Ana	California
United States	Alkermes Investigational Site	Torrance	California
United States	Alkermes Investigational Site	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Fava M, Memisoglu A, Thase ME, Bodkin JA, Trivedi MH, de Somer M, Du Y, Leigh-Pemberton R, DiPetrillo L, Silverman B, Ehrich E. Opioid Modulation With Buprenorphine/Samidorphan as Adjunctive Treatment for Inadequate Response to Antidepressants: A Randomiz — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 4 in Hamilton Rating Scale for Depression (HAM-D17) Total Score	The HAM-D17 scale is a clinician-administered questionnaire comprised of 17 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 50 (most severe symptoms). Individual questionnaire items include depressed mood, work and activities, insomnia (early), insomnia (middle), insomnia (late), genital symptoms, somatic symptoms (gastrointestinal), loss of weight, somatic symptoms (general), feelings of guilt, suicide, anxiety (psychic), anxiety (somatic), hypochondriasis, insight, agitation, and retardation.	Baseline and 4 weeks for each stage
Secondary	Proportion of Patients Who Exhibited Treatment Response (HAM-D17)	The proportion of subjects demonstrating HAM-D17 treatment response, defined as a = 50% reduction in HAM-D17 score from baseline to the end of the efficacy period (Week 4). The HAM-D17 is a clinician administered questionnaire comprised of 17 questions used to assess the severity of a patient's depression. Scores range from 0 (no apparent symptoms) to 50 (most severe symptoms). Individual questionnaire items include depressed mood, work and activities, insomnia (early), insomnia (middle), insomnia (late), genital symptoms, somatic symptoms (gastrointestinal), loss of weight, somatic symptoms (general), feelings of guilt, suicide, anxiety (psychic), anxiety (somatic), hypochondriasis, insight, agitation, and retardation.	4 weeks for each stage
Secondary	Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score	The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of 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.	4 weeks for each stage
Secondary	Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score	The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is at a specific point in time. Based on the scale, patients are categorized as follows: "1: normal, not at all ill"; "2: borderline mentally ill"; "3: mildly ill"; "4: moderately ill"; "5: markedly ill"; "6: severely ill"; and "7: among the most extremely ill patients."	4 weeks for each stage