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Treatment Study of Bipolar Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00947791
Recruitment Status : Terminated (Change in available resources for study procedures)
First Posted : July 28, 2009
Results First Posted : May 17, 2017
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
James Murrough, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Bipolar Disorder
Interventions Drug: ketamine
Drug: midazolam
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ketamine/Midazolam Midazolam/Ketamine
Hide Arm/Group Description Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
Period Title: Overall Study
Started 0 1
Completed 0 1
Not Completed 0 0
Arm/Group Title Ketamine/Midazolam Midazolam/Ketamine Total
Hide Arm/Group Description Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg Total of all reporting groups
Overall Number of Baseline Participants 0 0 0
Hide Baseline Analysis Population Description
Based on confidentiality concerns, 0 participants analyzed.
Age, Continuous  
Number Analyzed 0 participants 0 participants 0 participants
Sex: Female, Male  
Number Analyzed 0 participants 0 participants 0 participants
Female 0
Male 0
1.Primary Outcome
Title Montgomery-Asberg Depression Rating Scale (MADRS)
Hide Description [Not Specified]
Time Frame 24 hrs post-infusion compared to baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Based on confidentiality concerns, 0 participants analyzed.
Arm/Group Title Ketamine/Midazolam Midazolam/Ketamine
Hide Arm/Group Description:
Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR)
Hide Description [Not Specified]
Time Frame 24 hrs post-infusion compared to baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Based on confidentiality concerns, 0 participants analyzed.
Arm/Group Title Ketamine/Midazolam Midazolam/Ketamine
Hide Arm/Group Description:
Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Young Mania Rating Scale (YMRS)
Hide Description [Not Specified]
Time Frame 24 hrs post-infusion compared to baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Based on confidentiality concerns, 0 participants analyzed.
Arm/Group Title Ketamine/Midazolam Midazolam/Ketamine
Hide Arm/Group Description:
Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Brief Psychiatric Rating Scale (BPRS)
Hide Description [Not Specified]
Time Frame 4 hrs post-infusion compared to baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Based on confidentiality concerns, 0 participants analyzed.
Arm/Group Title Ketamine/Midazolam Midazolam/Ketamine
Hide Arm/Group Description:
Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Clinician-Administered Dissociative States Scale (CADSS)
Hide Description [Not Specified]
Time Frame 4 hrs post-infusion compared to baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Based on confidentiality concerns, 0 participants analyzed.
Arm/Group Title Ketamine/Midazolam Midazolam/Ketamine
Hide Arm/Group Description:
Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Systematic Assessment for Treatment Emergent Effects (SAFTEE)
Hide Description [Not Specified]
Time Frame 4 hrs post-infusion compared to baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Based on confidentiality concerns, 0 participants analyzed.
Arm/Group Title Ketamine/Midazolam Midazolam/Ketamine
Hide Arm/Group Description:
Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse Events information not collected
 
Arm/Group Title Ketamine/Midazolam Midazolam/Ketamine
Hide Arm/Group Description Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
All-Cause Mortality
Ketamine/Midazolam Midazolam/Ketamine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Serious Adverse Events
Ketamine/Midazolam Midazolam/Ketamine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketamine/Midazolam Midazolam/Ketamine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. James W. Murrough
Organization: Icahn School of Medicine at Mount Sinai
Phone: 212-241-6539
EMail: james.murrough@mssm.edu
Layout table for additonal information
Responsible Party: James Murrough, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00947791    
Other Study ID Numbers: GCO 08-1422
First Submitted: July 27, 2009
First Posted: July 28, 2009
Results First Submitted: April 11, 2017
Results First Posted: May 17, 2017
Last Update Posted: May 17, 2017