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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH092434 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study investigates if a single dose of IV Ketamine can rapidly improve Obsessive-Compulsive Disorder (OCD) symptoms and whether these effect can be maintained with a condensed course of a type of Cognitive Behavioral Therapy called Exposure and Response Prevention (EX/RP). You will be compensated for your time and travel. Participants must be between the ages of 18-55.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine, Exposure & Response Prevention | Experimental | 0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | 0.5mg/kg IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale | Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
period of the study
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| Name | Affiliation | Role |
|---|---|---|
| H Blair Simpson, MD, PhD | Columbia-NYSPI-RFMH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Insitute | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27046314 | Result | Rodriguez CI, Wheaton M, Zwerling J, Steinman SA, Sonnenfeld D, Galfalvy H, Simpson HB. Can exposure-based CBT extend the effects of intravenous ketamine in obsessive-compulsive disorder? an open-label trial. J Clin Psychiatry. 2016 Mar;77(3):408-9. doi: 10.4088/JCP.15l10138. No abstract available. |
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No pre-assignment was done.
Adult outpatients were recruited from the community starting March 2014 until March 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketamine, Exposure & Response Prevention | 0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP) Ketamine: 0.5mg/kg IV Exposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketamine, Exposure & Response Prevention | 0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP) Ketamine: 0.5mg/kg IV Exposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale | Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS. | Posted | Number | participants | 2 weeks |
|
4 weeks
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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 | Ketamine, Exposure & Response Prevention | 0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP) Ketamine: 0.5mg/kg IV Exposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carolyn Rodriguez, Assistant Professor | Stanford University | 6507236158 | carolynrodriguez@stanford.edu |
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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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| Exposure and Response Prevention | Behavioral | A type of Cognitive Behavioral Therapy called Exposure and Response Prevention. |
|
|
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Gender | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
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|
| 0 |
| 10 |
| 0 |
| 10 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |