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Terminated due to difficulty in recruiting participants.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine/Placebo | Experimental | 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. |
|
| Placebo/Ketamine | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Observing if Ketamine May Cause a Decrease in OCD Symptoms | 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. | Baseline to Week 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian P Brennan, M.D. | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 | United States |
One subject completed the screening visit, but chose to withdraw from study due to time commitment required. Because this subject only completed a screening visit, she was never entered into the treatment arm of the study (which begins at the baseline visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | No participants enrolled in treatment portion of study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | No participants enrolled in treatment portion of study, and therefore never completed a baseline visit. One subject completed a screening visit and then withdrew from study due to time commitments. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Observing if Ketamine May Cause a Decrease in OCD Symptoms | 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. | One subject had a screening visit, but was never enrolled in the treatment portion and therefore never had any sort of treatment analysis performed on her data. | Posted | Baseline to Week 5 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | No participants enrolled in treatment portion of study. One subject had a screening visit, but since she never entered the treatment portion of the study and never received the study medication. Because she never had any exposure to the study medication and had no visits other than the initial screening visit, she was never at risk for any adverse events related to study medication. No adverse events related to study medication were collected since no subjects ever entered the treatment phase of this study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian Brennan, MD | McLean Hospital, Biological Psychiatry Laboratory | 617-855-2911 | bbrennan@partners.org |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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|
|
| Age, Continuous |
| Sex: Female, Male |
|
| Region of Enrollment | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |