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NCT01558063 · ClinicalTrials.gov registry record · Phase 2
Ketamine in the Treatment of Depression
A Phase 2 study of Major Depressive Disorder, sponsored by Columbia University.
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT01558063: Completed Phase 2 study of Major Depressive Disorder, sponsored by Columbia University.
NCT01558063 is a Phase 2 study of Major Depressive Disorder that has completed, run by Columbia University. The registered enrollment target is 38 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01558063, a Phase 2 study of Major Depressive Disorder, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
Depressed patients will be offered experimental treatment with a new, potentially fast-acting antidepressant called ketamine while being scanned by magnetic resonance imaging (MRI) to measure the chemical effect of the drug. Ketamine will be given in a dose of 0.0 (placebo), 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg. If a patient does not respond to ketamine after the first infusion, it may be because s/he received ketamine placebo or the dose of ketamine was too low. In that case, an optional second scan and infusion of active ketamine (0.5 mg/kg) will be offered. This second scan will occur no later than weeks after the first scan/infusion (as scheduling permits). There is no guarantee that the patient will respond to the second ketamine infusion. Patients enrolled in the study are eligible for up to 6 months treatment with their study psychiatrist after the ketamine infusion(s). Healthy Volunteers: Healthy controls will receive an infusion of ketamine at a single dose (0.5 mg/kg). Volunteers will only receive one MRI scan and infusion.
Primary Outcome
The quantitative depressive symptom ratings were collected at Baseline, Day 1 (post ketamine), Day 3 using HDRS-24 (a 24-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery). The total score can range from 0 to a maximum score of 15 with a higher score indicating a worse outcome. A "responder" was defined as an individual exhibiting a reduction in the HDRS score from baseline to 24 hours (day 1) post-treatment, and all other individuals were classi
Conditions Studied
Interventions
- DRUG Ketamine
- PROCEDURE Magnetic Resonance Imaging (MRI)
- DRUG Saline
Study Locations (1)
New York
- New York State Psychiatric Institute - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2012-02 |
| Est. Completion | 2019-10 |
| Phase | Phase 2 |
What the finished NCT01558063 record still lists
NCT01558063 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 3 interventions - of which Ketamine is the first listed.
NCT01558063 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01558063 about?
NCT01558063 is a clinical study titled "Ketamine in the Treatment of Depression". Depressed patients will be offered experimental treatment with a new, potentially fast-acting antidepressant called ketamine while being scanned by magnetic resonance imaging (MRI) to measure the chemical effect of the drug. Ketamine will be given in a dose of 0.0 (placebo), 0.1, 0.2, 0.3, 0.4, or 0...
What is the current status of trial NCT01558063?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2012-02. Estimated completion is 2019-10.
What conditions does trial NCT01558063 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT01558063?
The interventions under investigation include: Ketamine (DRUG), Magnetic Resonance Imaging (MRI) (PROCEDURE), Saline (DRUG).
Who is sponsoring clinical trial NCT01558063?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01558063 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
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 NCT01558063's enrollment target sits among peer trials
38 208th of 282 higher than 73 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder 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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