NCT02085135CompletedPhase 3
A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Tolerability of Two Titration Schedules for ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder in Adults With an Inadequate Response to Antidepressant Therapy (the FORWARD-1 Study)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Alkermes, Inc.
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Number of Subjects With Adverse Events (AEs)
Study Overview
Brief Summary
This is a Phase 3 study designed to evaluate the safety and tolerability of two titration schedules for ALKS 5461.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Body mass index of 18-40 kg/m2
- •Have a diagnosis of MDD
- •Have a current major depressive episode (MDE) lasting 8 weeks to 24 months
- •Have been treated with an adequate dose of an approved antidepressant during the current MDE for at least 8 weeks
- •Have an inadequate response to current antidepressant treatment
- •Agree to use an approved method of birth control for the duration of the study
- •Additional criteria may apply
Exclusion Criteria
- •Currently pregnant or breastfeeding
- •History of or current infection with Hepatitis B Virus, Hepatitis C Virus or Human Immunodeficiency Virus (HIV)
- •Have experienced hallucinations, delusions, or any psychotic symptoms in the current MDE
- •Have used opioid agonists (eg, codeine, oxycodone, tramadol, or morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
- •Have received electroconvulsive therapy treatment within the last 5 years
- •Have attempted suicide within the past 2 years
- •Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
- •Have had a significant blood loss or blood donation with 60 days of screening
- •Additional criteria may apply
Arms & Interventions
Titration Schedule 1
Experimental
Intervention: ALKS 5461 (Drug)
Titration Schedule 2
Experimental
Intervention: ALKS 5461 (Drug)
Outcomes
Primary Outcomes
Number of Subjects With Adverse Events (AEs)
Time Frame: 8 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 3
Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10)Pneumococcal DiseaseNCT05569954Merck Sharp & Dohme LLC1,484
Completed
Phase 3
Safety and Immunogenicity of V116 in Vaccine-naïve Japanese Older Adults (V116-009, STRIDE-9)Pneumococcal DiseaseNCT05633992Merck Sharp & Dohme LLC450
Completed
Phase 3
Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)Pneumococcal InfectionNCT05425732Merck Sharp & Dohme LLC2,663
Completed
Phase 3
A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Non Alcoholic Fatty Liver Disease PatientsNon-Alcoholic Fatty Liver DiseaseNCT04197479Madrigal Pharmaceuticals, Inc.1,343
Completed
Phase 3
Safety of Daily Dose Esomeprazole for GERD for Pediatric and Adolescent PatientsGastroesophageal Reflux Disease (GERD)NCT00241501AstraZeneca140