Safety and Efficacy of MK-6096 as Adjunctive Therapy in Participants With Major Depressive Disorder And Partial Response to Antidepressant Monotherapy (MK-6096-022 AM3)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01554176
First received: March 12, 2012
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to evaluate the safety and efficacy of MK-6096 versus placebo as adjunctive treatment for major depressive disorder (MDD), in participants who have failed to demonstrate a complete response to treatment with an antidepressant (one of identified selective serotonin reuptake inhibitors [SSRIs] or serotonin norepinephrine reuptake inhibitors [SNRIs], or bupropion). The primary hypothesis of the study is that MK-6096 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.


Condition Intervention Phase
Major Depressive Disorder, Recurrent
Drug: MK-6096
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIa, Multicenter, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-6096 for Treatment Augmentation in Patients With Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change from Baseline to Week 6 in MADRS total score [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline to Week 6 in MADRS total score excluding the sleep item [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  • Change from Baseline to Week 6 in the Hamilton Depression Rating Scale, 17-item version (HAM-D17) Bech subscale score [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  • Proportion of patients with HAM-D17 remission (HAM-D17 total score ≤7) at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Enrollment: 129
Study Start Date: May 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-6096
6-week treatment period - Double-blind MK-6096; 2-week run-out period - Double-blind MK-6096 or placebo in 1:1 ratio
Drug: MK-6096
MK-6096, one 10 mg tablet, orally, once daily
Placebo Comparator: Placebo
6-week treatment period and 2-week run-out period - Double-blind placebo
Drug: Placebo
Placebo, one tablet, orally, once daily

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 MK-6096 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 MK-6096 in the 6-week treatment period will receive either MK-6096 or placebo in a 1:1 ratio.

  Eligibility

Ages Eligible for Study:   21 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Male, female not of reproductive potential, or female of reproductive potential who is not pregnant 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

Key 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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01554176     History of Changes
Other Study ID Numbers: 6096-022
Study First Received: March 12, 2012
Last Updated: September 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Current depressive episode
moderate to severe

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Recurrence
Mood Disorders
Mental Disorders
Behavioral Symptoms
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014