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| ID | Type | Description | Link |
|---|---|---|---|
| HSM#11-01536 | Other Identifier | THE MOUNT SINAI HEALTH SYSTEM |
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no funding
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| Name | Class |
|---|---|
| Icahn School of Medicine at Mount Sinai | OTHER |
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Obsessive-Compulsive Disorder (OCD) is a chronic and disabling anxiety disorder and a leading cause of worldwide disability that presents a significant public health problem. Treatment options are limited and many OCD patients fail to respond completely or quickly to standard treatments, including pharmacotherapy and psychotherapy. At this time, patients who fail to respond to treatment with serotonergic drugs, augmenting antipsychotic agents, and behavioral therapy, have few additional treatment options aside from deep brain stimulation. Therefore, despite advances in current pharmacological and behavioral treatments, and the utility of serotonergic drugs, it is likely that other neurotransmitter systems are involved and that targeting these systems may increase treatment efficacy. Despite little evidence for serotonergic dysfunction in OCD, there is significant evidence that glutamatergic dysregulation may contribute to the development and progression of the disorder. Also, preliminary studies suggest that glutamatergic modulators (i.e. riluzole and d-cycloserine), particularly agents acting at the NMDA receptor (i.e. memantine), may be useful in OCD. The NMDA antagonist, ketamine, has demonstrated rapid effects when delivered as a single intravenous (IV) dose in depressed patients. Therefore, the objective of the current study is to investigate the safety and efficacy of a single dose of IV ketamine in treatment-resistant OCD.
This study will test the safety and efficacy of a single intravenous (IV) dose of the N-methyl-D-aspartate (NMDA) glutamate receptor antagonist, ketamine, in treatment-resistant OCD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine | Active Comparator | Study participants will receive a one-time intravenous infusion of 0.5 mg/kg racemic ketamine hydrochloride |
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| Midazolam | Sham Comparator | Study participants will receive a one-time intravenous infusion of 0.045 mg/kg midazolam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | Ketamine hydrochloride is a nonbarbiturate anesthetic. It is formulated as a slight acid (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 50 or 100mg ketamine base per milliliter. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCCS) Rating OCD Symptom Severity From Baseline to 24-hours After Ketamine Administration | The primary efficacy outcome is change in the Y-BOCCS rating score on a scale from baseline to 24 hrs post-administration of ketamine. The 10 Y-BOCCS items are each scored on a four-point scale from 0 = "no symptoms" to 4 = "extreme symptoms." The sum of the first five items is a severity index for obsessions. The sum of the last five an index for compulsions. A translation of total score into an approximate index of overall severity is: 0-7 - subclinical; 8-15 - mild; 16-23 - moderate; 24-31 - severe; 32-40 - extreme. | Baseline and 24 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Meet Response and Remission | Percentage of patients who meet response (defined as 25% reduction in Y-BOCCS score) and remission (defined as Y-BOCS score ≤10) criteria at 24 hrs post-infusion and durability of efficacy up to two weeks after administration. Assessments will be performed 24, 48 and 72 hrs post-infusion and after 7, 10, and 14 days. | up to 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wayne K Goodman, MD | Baylor College of Medicine (previously Icahn School of Medicine at Mount Sinai) | Principal Investigator |
| Kyle Lapidus, MD | (previously Icahn School of Medicine at Mount Sinai) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Centers at Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
Eligible participants met treatment-resistant criteria if they failed to respond to ≥ 2 adequate pharmacotherapy trials with SRIs FDA approved medications for OCD with or without adjunctive antipsychotics, as well as cognitive behavioral therapy.
Subjects were recruited from the Mood and Anxiety Disorders Program (MAPs). In addition, referrals from clinicians in the Mount Sinai Medical Center, community clinics, and affiliated hospitals were also sought.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketamine (Randomized Week 1, Cross Over Midazolam Week 3)) | Study participants will receive a one-time intravenous infusion of 0.5 mg/kg racemic ketamine hydrochloride Ketamine: Ketamine hydrochloride is a nonbarbiturate anesthetic. It is formulated as a slight acid (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 50 or 100mg ketamine base per milliliter. |
| FG001 | Midazolam (Randomized Wk 1, Cross Over Ketamine Wk 3) | Study participants will receive a one-time intravenous infusion of 0.045 mg/kg midazolam Midazolam: Midazolam is a short-acting benzodiazepine central nervous (CNS) depressant. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketamine (Randomized Week 1, Cross Over Midazolam Week 3)) | Study participants will receive a one-time intravenous infusion of 0.5 mg/kg racemic ketamine hydrochloride Ketamine: Ketamine hydrochloride is a nonbarbiturate anesthetic. It is formulated as a slight acid (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 50 or 100mg ketamine base per milliliter. |
| 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 | Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCCS) Rating OCD Symptom Severity From Baseline to 24-hours After Ketamine Administration | The primary efficacy outcome is change in the Y-BOCCS rating score on a scale from baseline to 24 hrs post-administration of ketamine. The 10 Y-BOCCS items are each scored on a four-point scale from 0 = "no symptoms" to 4 = "extreme symptoms." The sum of the first five items is a severity index for obsessions. The sum of the last five an index for compulsions. A translation of total score into an approximate index of overall severity is: 0-7 - subclinical; 8-15 - mild; 16-23 - moderate; 24-31 - severe; 32-40 - extreme. | Posted | Mean | Full Range | Units on a scale | Baseline and 24 Hours |
|
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 | Study participants will receive a one-time intravenous infusion of 0.5 mg/kg racemic ketamine hydrochloride Ketamine: Ketamine hydrochloride is a nonbarbiturate anesthetic. It is formulated as a slight acid (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 50 or 100mg ketamine base per milliliter. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidality | Psychiatric disorders | Systematic Assessment |
Early termination due to limited funding lead to small numbers of subjects analyzed (n=3) compared to what was planned (n=12).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wayne Goodman | Baylor College of Medicine (previously Icahn School of Medicine at Mount Sinai) | 713-798-4945 | wayne.goodman@bcm.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 |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Midazolam | Drug | Midazolam is a short-acting benzodiazepine central nervous (CNS) depressant. |
|
| BG001 | Midazolam (Randomized Wk 1, Cross Over Ketamine Wk 3) | Study participants will receive a one-time intravenous infusion of 0.045 mg/kg midazolam Midazolam: Midazolam is a short-acting benzodiazepine central nervous (CNS) depressant. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Midazolam (Randomized Wk 1, Cross Over Ketamine Wk 3) | Study participants will receive a one-time intravenous infusion of 0.045 mg/kg midazolam Midazolam: Midazolam is a short-acting benzodiazepine central nervous (CNS) depressant. |
|
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| Secondary | Percentage of Patients Who Meet Response and Remission | Percentage of patients who meet response (defined as 25% reduction in Y-BOCCS score) and remission (defined as Y-BOCS score ≤10) criteria at 24 hrs post-infusion and durability of efficacy up to two weeks after administration. Assessments will be performed 24, 48 and 72 hrs post-infusion and after 7, 10, and 14 days. | Posted | Number | percentage of participants | up to 14 days |
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| 0 |
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | Midazolam | Study participants will receive a one-time intravenous infusion of 0.045 mg/kg midazolam Midazolam: Midazolam is a short-acting benzodiazepine central nervous (CNS) depressant. | 0 | 2 | 0 | 2 | 1 | 2 |
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Fatigue | Psychiatric disorders | Systematic Assessment |
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |