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NCT00088699 · ClinicalTrials.gov registry record · Phase 1
Rapid Antidepressant Effects of Ketamine in Major Depression
A Phase 1 study of Depression and Mood Disorders, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 1
- Development phase
- 67
- Enrollment target
- 1
- Study location
NCT00088699: Completed Phase 1 study of Depression and Mood Disorders, sponsored by National Institute of Mental Health (NIMH).
NCT00088699 is a Phase 1 study of Depression and Mood Disorders that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 67 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00088699, a Phase 1 study of Depression and Mood Disorders, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 67 participants
- Enrollment target
- 1
- Study location
Study Summary
Depressive disorders may be severe, chronic and often life-threatening illnesses. Impairment in physical and social functioning resulting from depression can be just as severe as other chronic medical illnesses. Recent preclinical and clinical studies suggest that the glutamatergic system is involved in the mechanism of action of antidepressants. This study examines whether ketamine can cause a rapid-next day antidepressant effect in patients with Major Depressive Disorder. This study was designed to address the questions: Does the NMDA antagonist ketamine produce rapid antidepressant effects in patients with treatment-resistant major depression? What are the neurobiological correlates of antidepressant response (examining multi-modal MRI, MEG, polysomnography and serum markers) Patients, ages 18 to 65 years with treatment-resistant major (unipolar) depression will in a double-blind crossover study receive either intravenous ketamine or saline solution.
Primary Outcome
Antidepressant effects were assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS). It is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ketamine
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2004-07-26 |
| Est. Completion | 2017-07-31 |
| Phase | Phase 1 |
What the finished NCT00088699 record still lists
NCT00088699 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (91% lower).
The record links to 3 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00088699 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00088699 about?
NCT00088699 is a clinical study titled "Rapid Antidepressant Effects of Ketamine in Major Depression". Depressive disorders may be severe, chronic and often life-threatening illnesses. Impairment in physical and social functioning resulting from depression can be just as severe as other chronic medical illnesses. Recent preclinical and clinical studies suggest that the glutamatergic system is involve...
What is the current status of trial NCT00088699?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 67 participants. The study started on 2004-07-26. Estimated completion is 2017-07-31.
What conditions does trial NCT00088699 study?
This clinical trial studies the following conditions: Depression, Mood Disorders, Major Depresssion.
What interventions are being tested in trial NCT00088699?
The interventions under investigation include: Placebo (DRUG), Ketamine (DRUG).
Who is sponsoring clinical trial NCT00088699?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00088699 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 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 NCT00088699's enrollment target sits among peer trials
67 418th of 679 higher than 262 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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