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NCT00472576 · ClinicalTrials.gov registry record · Phase 1
Antidepressant Effects of NR2B in Major Depression
A Phase 1 study of Major Depression, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT00472576: Completed Phase 1 study of Major Depression, sponsored by National Institute of Mental Health (NIMH).
NCT00472576 is a Phase 1 study of Major Depression that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 5 participants, below the 327-participant average among 28 other Major Depression trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00472576, a Phase 1 study of Major Depression, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The Montgomery-Asberg Depression Rating Scale (MADRS) measures the severity of depression where smaller scores indicate less depression and higher scores suggest more severe depression. Possible scores for this 10 item version range from 0 to 60. Generally, a score of 18 or greater is used to indicate a substantial depression level. The measure at the end of the study is the primary outcome.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG MK-0657
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2007-05 |
| Est. Completion | 2009-08 |
| Phase | Phase 1 |
What the finished NCT00472576 record still lists
NCT00472576 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 327-participant average among 28 other Major Depression trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Major Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00472576 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00472576 about?
NCT00472576 is a clinical study titled "Antidepressant Effects of NR2B in Major Depression". 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 NMD...
What is the current status of trial NCT00472576?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2007-05. Estimated completion is 2009-08.
What conditions does trial NCT00472576 study?
This clinical trial studies the following conditions: Major Depression.
What interventions are being tested in trial NCT00472576?
The interventions under investigation include: Placebo (DRUG), MK-0657 (DRUG).
Who is sponsoring clinical trial NCT00472576?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00472576 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00472576's enrollment target sits among peer trials
5 29th of 28 the lowest of 28 other Major Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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