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

Alkermes

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: ALKS 5461 Placebo; Drug: ALKS 5461

Study type: Interventional

Funder types: Industry

Identifiers

NCT03188185

ALK5461-217

Details and patient eligibility

About

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

Enrollment: 278 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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278 participants in 2 patient groups, including a placebo group

ALKS 5461

Experimental group

Description:

Sublingual tablets

Treatment:

Drug: ALKS 5461

ALKS 5461 Placebo

Placebo Comparator group

Description:

Sublingual tablets

Treatment:

Drug: ALKS 5461 Placebo