To Test the Potential Efficacy of Repeated Intranasal Administration of Ketamine as a Treatment for PTSD
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|ClinicalTrials.gov Identifier: NCT02398136|
Recruitment Status : Withdrawn (FDA and IRB recommended different mode of medication administration)
First Posted : March 25, 2015
Last Update Posted : March 25, 2015
|Condition or disease||Intervention/treatment||Phase|
|PTSD||Drug: Ketamine Drug: Midazolam||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Randomized Controlled Trial of Repeated Dose Ketamine in Post Traumatic Stress Disorder (PTSD)|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Intranasal ketamine up to 75 mg, delivered over 20 minutes, frequency: 3x/week for 4 weeks.
Other Name: Intranasal ketamine
Active Comparator: Midazolam
Intranasal midazolam 3.75mg, delivered over 20 minutes, frequency: 3x/week for 4 weeks.
Other Name: Placebo
- Impact of Events Scale-Revised (IES-R) [ Time Frame: 24 hours ]The IES-R is used to self-report measures of stress reactions to traumatic events. It measures both intrusion and avoidance.
- Clinician Administered PTSD Scale (CAPS) [ Time Frame: up to 4 weeks ]The CAPS is a structured clinical interview designed to assess the essential features of PTSD.
- Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR) [ Time Frame: 24 hours ]The QIDS-SR is a 16-item self-rated instrument designed to assess the severity of depressive symptoms present in the past seven days.
- Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 24 hours ]The MADRS is a 10-item instrument used for the evaluation of depressive symptoms and for the assessment of any changes to those symptoms.
- Patient-Rated Inventory of Side Effects (PRISE) [ Time Frame: 24 hours ]PRISE is a 7-item self report used to qualify side effects by identifying and evaluating the tolerability of each symptoms.
- Sheehan Disability Scale (SDS) [ Time Frame: 24 hours ]The SDS is a 10 point visual analog scale developed to assess functional impairment.
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): NCT02398136
|Principal Investigator:||Adriana Feder, MD||Icahn School of Medicine at Mount Sinai|