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Study was never funded nor started, no participants were enrolled
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| Name | Class |
|---|---|
| Icahn School of Medicine at Mount Sinai | OTHER |
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The objective of the current study is to investigate the safety, efficacy, and feasibility of multiple doses of intranasal (IN) ketamine for suicidal ideation Veterans.
To address the significant need for effective treatment of suicidal ideation in Veterans, this trial is designed as an open label pilot study of intranasal ketamine in 15 people.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal Ketamine | Experimental | Subjects will receive study medication, intranasal ketamine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | 8 doses of intranasal ketamine; 40 mg per dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Beck Scale for Suicidal Ideation (BSSI) | Beck Scale is a 21-item self or clinician administered instrumentation used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide. Score range 0-42, with higher score indicating higher intensity. | Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) | The MADRS is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. | Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James J. Peters VA Medical Center | The Bronx | New York | 10468 | United States |
All IPD that underlie results in publications as well as study protocol, statistical analysis plan, informed consent form.
6 months after publication and will remain available for 5 years.
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| ID | Term |
|---|---|
| D059020 | Suicidal Ideation |
| D013405 | Suicide |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| The Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) | QIDS-SR is a 16-item self-rated instrument designed to assess the severity of depressive symptoms present in the past seven days (Rush et al. 2003). The 16 items cover the nine symptom domains of major depression, and are rated on a scale of 0-3. | Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |