A Trial of Intranasal Ketamine for the Treatment of Obsessive-Compulsive Disorder
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|ClinicalTrials.gov Identifier: NCT02234011|
Recruitment Status : Terminated (Terminated due to difficulty in recruiting participants.)
First Posted : September 9, 2014
Results First Posted : May 12, 2017
Last Update Posted : May 12, 2017
This study is being done to learn whether administration of intranasal (inhaled through the nose) ketamine reduces symptoms of obsessive-compulsive disorder (OCD). Ketamine has been approved by the U.S. Food and Drug Administration (FDA) as an anesthetic agent (a medicine to reduce pain during surgery and other procedures) but ketamine has not been approved by the FDA as a treatment for OCD.
The investigators believe that ketamine may be effective in reducing symptoms of OCD due to its ability to decrease the activity of a specific brain chemical called glutamate. Previous studies have shown that people with OCD can have abnormal levels of glutamate in their brains. This is the first time that intranasal ketamine is being studied in people with OCD. However, studies have been done in the past using intravenous (IV; through a needle into a vein in your arm) ketamine in people with OCD, and intranasal ketamine has been studied in people with other psychiatric conditions.
This research study will compare ketamine to placebo. The placebo looks exactly like ketamine, but contains no ketamine. At some time during the study, the investigators will give you ketamine. At another time, the investigators will give you placebo. Placebos are used in research studies to see if the results are due to the study drug or due to other reasons.
|Condition or disease||Intervention/treatment||Phase|
|Obsessive-Compulsive Disorder||Drug: Ketamine Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Placebo-Controlled Crossover Trial of Intranasal Ketamine for the Treatment of Obsessive-Compulsive Disorder|
|Actual Study Start Date :||September 2014|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Participants in this group will receive 5 sprays (10 mg each) of intranasal ketamine for the first treatment visit, then receive 5 sprays of placebo (saline solution) at the second treatment visit two weeks later.
Participants in this group will receive 5 sprays of placebo (saline solution) for the first treatment visit, then receive 5 sprays (10 mg each) of intranasal ketamine at the second treatment visit two weeks later.
- Observing if Ketamine May Cause a Decrease in OCD Symptoms [ Time Frame: Baseline to Week 5 ]
Examining if ketamine is associated with a decrease in OCD symptoms as measured by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) at completion of one treatment when compared to placebo (saline solution).
The Y-BOCS measures OCD symptoms on a scale of 0-40, with higher numbers indicating greater severity of OCD symptoms. For this study, subjects had to have a Y-BOCS of greater than or equal to 18 in order to participate.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02234011
|United States, Massachusetts|
|Belmont, Massachusetts, United States, 02478|
|Principal Investigator:||Brian P Brennan, M.D.||Mclean Hospital|