Safety and Efficacy of MK-6096 as Adjunctive Therapy in Participants With Major Depressive Disorder And Partial Response to Antidepressant Monotherapy (MK-6096-022)

NCT ID: NCT01554176

Last Updated: 2018-11-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-18
• Study Completion Date: 2013-09-03

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of filorexant (MK-6096) versus placebo as adjunctive treatment for major depressive disorder (MDD), in participants who are partial responders to antidepressant monotherapy with one of identified selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), or bupropion. The primary hypothesis of the study is that filorexant is superior to placebo as augmentation therapy with respect to change from baseline to Week 6 in the Montgomery Asberg Depression Rating Scale (MADRS) total score.

Detailed Description

Participants will continue to take their pretrial antidepressant medication as prescribed throughout the trial. Participants will be randomized in a 1:1 ratio to receive filorexant or placebo for a 6-week treatment period. Following completion of the treatment period, participants will enter a 2-week double-blind run-out period. During the run-out period, participants who received placebo in the 6-week treatment period will continue to receive placebo and participants who received filorexant in the 6-week treatment period will be randomized to receive either filorexant or placebo in a 1:1 ratio.

Conditions

Major Depressive Disorder, Recurrent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Filorexant 10 mg (Treatment Phase)

Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.

Group Type: EXPERIMENTAL

Filorexant

Intervention Type: DRUG

Filorexant, one 10 mg tablet, orally, once daily at bedtime

Placebo (Treatment Phase)

Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo, one tablet, orally, once daily at bedtime

Filorexant 10 mg/Filorexant 10 mg (Run-out Phase)

Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.

Group Type: EXPERIMENTAL

Filorexant

Intervention Type: DRUG

Filorexant, one 10 mg tablet, orally, once daily at bedtime

Filorexant 10 mg/Placebo (Run-out Phase)

Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.

Group Type: PLACEBO_COMPARATOR

Filorexant

Intervention Type: DRUG

Filorexant, one 10 mg tablet, orally, once daily at bedtime

Placebo

Intervention Type: DRUG

Placebo, one tablet, orally, once daily at bedtime

Placebo/Placebo (Run-out Phase)

Run-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo, one tablet, orally, once daily at bedtime

Interventions

Filorexant

Filorexant, one 10 mg tablet, orally, once daily at bedtime

Intervention Type: DRUG

Placebo

Placebo, one tablet, orally, once daily at bedtime

Intervention Type: DRUG

Other Intervention Names

MK-6096

Eligibility Criteria

Inclusion Criteria

• Participant is (a) male or (b) female and not of reproductive potential, or (c) female of reproductive potential has a serum beta-hCG level consistent with the nongravid state at screening and agrees to use acceptable contraception;
• Current primary diagnosis of recurrent major depressive disorder, without psychotic features, with a current moderate or severe depressive episode;
• Duration of the current major depressive episode must be at least 2 months but no more than 18 months at Screening;
• Participant has undergone an adequate trial of an antidepressant (one of identified SSRIs or SNRIs, or bupropion) for the current depressive episode.

Exclusion Criteria

• Current primary psychiatric diagnosis other than major depression;
• Lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or other psychotic disorder;
• Alcohol or other substance abuse or dependence (excluding nicotine);
• Clinically significant abnormality or disease of the central nervous system (including dementia and other cognitive disorders or traumatic brain injury);
• Imminent risk of self-harm or of harm to others;
• Participant is a psychiatric inpatient;
• Participant has been on continuous antidepressant treatment for >18 months prior to Screening visit;
• Inadequate response to more than 3 adequate antidepressant trials (including the current antidepressant treatment trial) for treatment of the current depressive episode;
• Participant ever received electroconvulsive therapy, transcranial magnetic stimulation, or vagal nerve stimulation for treatment of depression;
• History of narcolepsy, cataplexy, circadian rhythm disorder, parasomnia, sleep-related breathing disorder, restless legs syndrome, periodic limb movement disorder, excessive daytime sleepiness or difficulty sleeping due to a medical condition;
• Clinical, laboratory, or electrocardiogram (ECG) evidence of significant systemic disease;
• Cardiovascular event (e.g., myocardial infarction) or procedure (e.g., coronary artery bypass surgery) within 3 months of study;
• History of malignancy ≤5 years prior to study, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer;
• Body Mass Index >40 kg/m^2;
• Pregnancy, breast-feeding, or expecting to become pregnant.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Connor KM, Ceesay P, Hutzelmann J, Snavely D, Krystal AD, Trivedi MH, Thase M, Lines C, Herring WJ, Michelson D. Phase II Proof-of-Concept Trial of the Orexin Receptor Antagonist Filorexant (MK-6096) in Patients with Major Depressive Disorder. Int J Neuropsychopharmacol. 2017 Aug 1;20(8):613-618. doi: 10.1093/ijnp/pyx033.

Reference Type: RESULT

PMID: 28582570 (View on PubMed)

Other Identifiers

2011-005200-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

6096-022

Identifier Type: -

Identifier Source: org_study_id