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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00088699
The ClinicalTrials.gov registry entry for NCT00088699 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (91% lower). The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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