At a glance
ClinicalIndex Comparison Record- ✓Age 18-55 years, not of reproductive potential (postmenopausal, post-hysterectomy, post-bilateral oophorectomy, or post-bilateral tubal ligation)
- ✓DSM-IV Major Depression (296.3) without psychotic features, confirmed by SCID-P
- ✓MADRS score ≥22 at screen and at baseline
- ✓Treatment-resistant depression: documented failure of ≥2 adequate antidepressant trials or failure of prospective trial after single prior failure
- ✕Current or past bipolar disorder, psychotic disorder, or schizophrenia
- ✕Drug or alcohol dependence/abuse (including nicotine and caffeine) within 3 months
- ✕Obsessive Compulsive Disorder or Posttraumatic Stress Disorder diagnosis
- ✕Borderline or Antisocial Personality Disorder
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Investigation of the Antidepressant Effects of the Selective NR2B Antagonist MK-0657 in Major Depression
In Brief
A Phase 1 clinical trial evaluating MK-0657 and Placebo for Major Depression. Completed, enrolled 5 participants across 1 site.
Detailed Summary
Purpose : This study will determine whether MK-0657, a selective NR2B Antagonist, can quickly improve symptoms of depressed mood, psychomotor retardation, poor motivation and reduced enjoyment of things in patients with major depression. MK-0657 decreases the activity of a brain receptor called NMDA, which the chemical glutamate binds to, possibly inducing a rapid antidepressant response. People between 18 and 55 years of age who have major depression of at least 4 weeks' duration and have not been helped by two antidepressants approved for major depression may be eligible for this study. Women who are able to have children are excluded. Participants are admitted to the NIH Clinical Center for two study phases, as follows. Phase I (1 to 2 weeks): Patients are tapered off their current medications. Phase II (7 weeks): Patients are randomly assigned to take either MK-0657 or placebo (look-alike capsules with no active ingredient) by mouth for 12 days. At some point during the second part this phase, patients who had been taking MK-0657 are switched over to placebo and those who had been taking placebo are switched to MK-0657. Participants undergo the following procedures during the study:Physical examination twice (at the beginning and at the end of the study) Electrocardiogram (ECG) four times Blood tests about six times Rating scales up to 28 times to assess the effects of MK-0657 on mood and thinking Blood pressure measurements three times a day. Study examines the effectiveness of a new medication, targeting a system called glutamate, will improve depression when compared with placebo.
Study Details
Timeline
Interventions
Daily double-blind administration of the NR2B antagonist MK-0657 (4-8 mg/day)
Daily double-blind administration of placebo