Back to Depression And Anxiety
This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT02158546

NCT02158546
Completed Phase 3

Who may be able to join

Who might be able to join this trial:

  • Your body weight falls within a healthy to moderately overweight range (BMI between 18.0 and 40.0)
  • You are willing to use an accepted form of birth control for the whole length of the study
  • You have been diagnosed with Major Depressive Disorder (a form of serious, ongoing depression) as your main condition
  • You have tried no more than 2 antidepressant medications in your current episode of depression that did not work well enough
  • Additional criteria may apply (confirm with trial site)

Who may not be able to join:

  • You have another main mental health condition alongside depression
  • You have taken opioid-based painkillers (such as codeine, oxycodone, tramadol, or morphine) or opioid-blocking medications (such as naloxone or naltrexone) in the past 14 days
  • You have had electroconvulsive therapy (ECT, sometimes called "shock therapy") in the past 2 years, or have had more than one full course of ECT in your lifetime
  • You have attempted suicide in the past 2 years
  • A drug test shows the presence of non-prescribed substances in your system
  • You are currently pregnant, planning to become pregnant, or breastfeeding
  • You have had a bad reaction, allergy, or sensitivity to buprenorphine or opioid-blocking medications (such as naltrexone or naloxone)
  • You have lost a significant amount of blood or donated blood within the past 60 days
  • Additional criteria may apply (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
Alkermes, Inc.
Registry
clinicaltrials_gov
Start date
1 May 2014
Est. completion
1 December 2015

Where this trial is recruiting

🇧🇬 Bulgaria 🇺🇸 United States

Primary endpoints

Change From Baseline to End of Treatment (Week 6) in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov