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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014