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.

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 sites326 target enrollmentFebruary 22, 2012

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Enrollment: 326
Status: Active, not recruiting
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 22, 2012

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Eligibility Criteria

Inclusion Criteria

•Demographic
•Men and women between 21 and \< 65 years of age
•Patient is a male or female not of reproductive potential or female of reproductive potential agreeing to use 2 regionally accepted effective non\-hormonal forms of contraception (or abstinent)
•Patient’s caffeine consumption does not exceed \= 5 standard 6 oz cups/day and patient is willing to continue this behavior throughout the study.
•Patient’s alcohol consumption does not exceed 2 drinks/day, at least 3 hr before bedtime, and the patient is willing to continue this behavior throughout the study.
•Patient is able to read and operate an electronic diary.
•Patient is at least 75% compliant with completion of the electronic diary (eDiary) during the Screening Period. Patient must complete the eDiary entries for a minimum of 4 days.
•Primary diagnosis of recurrent MDD, without psychotic features (DSM\-IV\-TR).
•Duration of the current depressive episode must be at least 2 months but no more that 18 months at screening.
•At screening, patient is has been on an adequate trial of SSRI or SNRI (See Protocol, Table 2\-1\) for the current depressive episode. For this protocol, an adequate trial of an SSRI/SNRI is defined as at least 5 weeks of treatment with one of the antidepressants listed below, at an adequate dose for at least 3 weeks (see protocol Table 2\-1\). Adequacy of the trial, based on duration of treatment and dose must be confirmed by the Investigator with the patient’s primary treating clinician.

Exclusion Criteria

•Demographic
•Patient has a history of shift work (defined as permanent night shift or rotating day/night shift work) within the past 2 weeks
•Patient’s current depressive episode is his/her first depressive episode.
•Patient has a current primary diagnosis (ie, a diagnosis designated by the investigator as the primary source of current distress and functional impairment) of an Axis I disorder other than MDD.
•Patient has a lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or other psychotic disorder, as determined by the investigator. Note that a history of psychotic features in the context of a previous depressive episode is permitted; however psychotic features associated with the current episode are exclusionary.
•Patient has a known or suspected personality dysfunction that could, in the investigator's opinion, interfere with trial participation or efficacy evaluation. A patient with known antisocial or borderline personality disorder should be excluded.
•Patient has a diagnosis of mental retardation, a history of traumatic brain injury causing ongoing cognitive difficulties, Alzheimer's Disease or another form of dementia, or any chronic organic disease of the central nervous system.
•Patient is at imminent risk of self\-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C\-SSRS), or of harm to others in the opinion of the investigator. Patients must be excluded if they report suicidal ideation with intent, with or without a plan (i.e., MADRS item 10 \= 5 and/or Type 4 or 5 on the C\-SSRS) in the past 1 month or suicidal behavior in the past 6 months.
•Patient currently (within the past year) meets criteria for alcohol or other substance abuse or dependence (excluding nicotine), posttraumatic stress disorder (PTSD), obsessive compulsive disorder (OCD), or eating disorder.
•Patient has a positive screening urine drug screen (e.g., positive for benzodiazepines, cannabinoids, cocaine, etc.).