Major Depressive DisorderPhase 2NCT01500200

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

A Phase 2 study testing ALKS 5461 in people with Major Depressive Disorder, run by Alkermes, Inc. at 27 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: ALKS 5461
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 142 participants
Where: 27 sitesUnited States
Study dates: Dec 2011to Mar 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

United States27 sites

Alkermes Investigational Site
Atlanta, Georgia, 30308
Alkermes Investigational Site
Austin, Texas, 78754
Alkermes Investigational Site
Baltimore, Maryland, 21285
Alkermes Investigational Site
Bellevue, Washington, 98007
Alkermes Investigational Site
Berlin, New Jersey, 08009
Alkermes Investigational Site
Boston, Massachusetts, 02135
Alkermes Investigational Site
Brooklyn, New York, 11241
Alkermes Investigational Site
Canton, Ohio, 44718
Alkermes Investigational Site
Charleston, South Carolina, 29407
Alkermes Investigational Site
Dallas, Texas, 75235
Alkermes Investigational Site
Dayton, Ohio, 45417
Alkermes Investigational Site
Fort Myers, Florida, 33912
Alkermes Investigational Site
Haverhill, Massachusetts, 01830
Alkermes Investigational Site
Hoffman Estates, Illinois, 60169
Alkermes Investigational Site
Houston, Texas, 77081
Alkermes Investigational Site
Lauderhill, Florida, 33319
Alkermes Investigational Site
Leesburg, Florida, 34748
Alkermes Investigational Site
New York, New York, 10021
Alkermes Investigational Site
North Miami, Florida, 33161
Alkermes Investigational Site
Oceanside, California, 92056
Alkermes Investigational Site
Oklahoma City, Oklahoma, 73112
Alkermes Investigational Site
Philadelphia, Pennsylvania, 19104
Alkermes Investigational Site
San Antonio, Texas, 78229
Alkermes Investigational Site
Santa Ana, California, 92701
Alkermes Investigational Site
St. Petersburg, Florida, 33716
Alkermes Investigational Site
Torrance, California, 90502
Alkermes Investigational Site
Tucson, Arizona, 85712

Other trials in United States

About this study

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

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.

Read the detailed 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.

Conditions: Major Depressive Disorder
Being tested: ALKS 5461, Placebo
Medical subject headings: Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ALKS 5461Drug
Two active tablets, given daily
PlaceboDrug
Two placebo tablets, given daily

Study groups in NCT01500200
Study group	Role	What they receive
ALKS 5461	Experimental	Not described Receives: Drug: ALKS 5461
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and 4 weeks for each stage

Secondary outcomes (3)

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.
Measured: 4 weeks for each stage
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.
Measured: 4 weeks for each stage
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."
Measured: 4 weeks for each stage

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Mar 2013

First posted28 Dec 2011 (estimated)
Study startDec 2011
Primary completionMar 2013
Study completionMar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 142 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01500200
Sponsor's protocol ID: ALK5461-202
Status last verified: Apr 2019
First submitted: 22 Dec 2011
Last updated: 21 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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 Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2016 May 1;173(5):499-508. doi: 10.1176/appi.ajp.2015.15070921. Epub 2016 Feb 12.
PubMed 26869247

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
Mood Disorders, Major Depressive Diorder
RecruitingPhase 3
A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder
Major Depressive Disorder
RecruitingPhase 1
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
Healthy Volunteer, Major Depressive Disorder
Recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Recruiting
Ketogenic Diet and Neuromodulation in Treatment Resistant Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)

All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01500200
Acronym / sponsor ID: ALK5461-202
Conditions: Major Depressive Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 142 participants (actual)
Lead sponsor: Alkermes, Inc.Industry (pharma, biotech, devices)
Study start: Dec 2011
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 28 Dec 2011 (estimated)
Results: Posted 21 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
ALKS 5461	Experimental	Drug: ALKS 5461
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ALKS 5461Two active tablets, given daily	Drug	ALKS 5461
PlaceboTwo placebo tablets, given daily	Drug	Placebo

Primary outcome

Change From Baseline to Week 4 in Hamilton Rating Scale for Depression (HAM-D17) Total Score
Time frame: Baseline and 4 weeks for each stage
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.

3 secondary outcomes

Proportion of Patients Who Exhibited Treatment Response (HAM-D17)
Time frame: 4 weeks for each stage
Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score
Time frame: 4 weeks for each stage
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score
Time frame: 4 weeks for each stage

Results and safety

Results posted to the registry on 21 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo S1	98	90
ALKS 5461 2mg/2mg S1	24	18
ALKS 5461 8mg/8mg S1	19	13
Placebo S2	0	0
ALKS 5461 2mg/2mg S2	0	0
ALKS 5461 8mg/8mg S2	0	0

Primary outcome: Change From Baseline to Week 4 in Hamilton Rating Scale for Depression (HAM-D17) Total Score

Time frame: Baseline and 4 weeks for each stage. Least squares mean (Standard Error). Unit: score on a scale

Measure	Placebo S1 n = 95	ALKS 5461 2mg/2mg S1 n = 20	ALKS 5461 8mg/8mg S1 n = 20	Placebo S2 n = 20	ALKS 5461 2mg/2mg S2 n = 23	ALKS 5461 8mg/8mg S2 n = 22
Value	-7.1 (0.6)	-9.3 (1.5)	-6.6 (1.6)	-1.5 (1.1)	-5.2 (1.2)	-3.3 (1.1)

Placebo S1 vs ALKS 5461 2mg/2mg S1 vs Placebo S2 vs ALKS 5461 2mg/2mg S2: p = 0.014, Mixed Models Analysis
Placebo S1 vs ALKS 5461 8mg/8mg S1 vs Placebo S2 vs ALKS 5461 8mg/8mg S2: p = 0.699, Mixed Models Analysis

Population analysed: Stage 1 and Stage 2 Full Analysis Sets (FAS) consisted of subjects who were randomized and took at least 1 dose of study drug and had at least 1 postbaseline HAM-D17 assessment in the respective stage. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 8/8 group for efficacy analysis.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 weeks for each stage. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo S1	1 of 98 (1%)	42 of 98 (42.9%)	0 of 98
ALKS 5461 2mg/2mg S1	1 of 24 (4.2%)	15 of 24 (62.5%)	0 of 24
ALKS 5461 8mg/8mg S1	0 of 19 (0%)	18 of 19 (94.7%)	0 of 19
Placebo S2	0 of 20 (0%)	11 of 20 (55%)	0 of 20
ALKS 5461 2mg/2mg S2	1 of 23 (4.3%)	19 of 23 (82.6%)	0 of 23
ALKS 5461 8mg/8mg S2	0 of 22 (0%)	17 of 22 (77.3%)	0 of 22

Limitations and caveats (from the sponsor): Two subjects randomized to 8/8 received 2/2 and are presented in the Participant Flow, Baseline, and AE tables by actual treatment received. For the outcome measures, subjects were analyzed by randomization treatment assignment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26869247Fava 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 Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2016 May 1;173(5):499-508. doi: 10.1176/appi.ajp.2015.15070921. Epub 2016 Feb 12.

Related trials for Major Depressive Disorder

Not yet recruitingObservational study
Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
Mood Disorders, Major Depressive Diorder
RecruitingPhase 3
A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder
Major Depressive Disorder
RecruitingPhase 1
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
Healthy Volunteer, Major Depressive Disorder
Recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Recruiting
Ketogenic Diet and Neuromodulation in Treatment Resistant Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Richard Leigh-Pemberton, MD study director

Alkermes, Inc.

27 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ALKS 5461 in people with Major Depressive Disorder, run by Alkermes, Inc. at 27 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 4 in Hamilton Rating Scale for Depression (HAM-D17) Total Score (time frame: Baseline and 4 weeks for each stage). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01500200, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2019.