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)
Status: | Completed |
---|---|
Conditions: | Depression, Major Depression Disorder (MDD) |
Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 21 - 64 |
Updated: | 7/16/2013 |
Start Date: | May 2012 |
End Date: | March 2016 |
Contact: | Toll Free Number |
Phone: | 1-888-577-8839 |
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
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.
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.
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
We found this trial at
14
sites
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