Efficacy of Repeated Ketamine Infusions for Treatment-resistant Depression
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|ClinicalTrials.gov Identifier: NCT02360280|
Recruitment Status : Completed
First Posted : February 10, 2015
Results First Posted : December 3, 2019
Last Update Posted : December 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Treatment-resistant Depression||Drug: ketamine Drug: midazolam||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Intravenous Sub-anesthetic Ketamine Treatment in Treatment-Resistant Depression|
|Actual Study Start Date :||April 1, 2015|
|Actual Primary Completion Date :||October 22, 2018|
|Actual Study Completion Date :||March 19, 2019|
Experimental: Six ketamine infusions
Six infusions of 0.5 mg/Kg of ketamine hydrochloride solution over 2 weeks.
Active Comparator: Single ketamine infusion preceded by 5 midazolam infusions
Single infusion of 0.5 mg/Kg of ketamine hydrochloride solution preceded by midazolam 0.045 mg/kg over 2 weeks.
- Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score After 12 Days of Treatment [ Time Frame: 13 days ]Average difference in the Montgomery-Asberg Depression Rating Scale (MADRS) score change between groups. The MADRS has 10-items which are based on mood symptoms over the past 7 days. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression).
- Antidepressant Response Defined as >50% Decrease in MADRS Baseline Score [ Time Frame: 13 days ]Comparing the number of subjects that achieve response between groups as defined above.
- Remission Defined as MADRS Score Equal or Less Than 9 [ Time Frame: 13 days ]Comparing the number of subjects that achieve remission between groups as defined above
- Time From Post-infusion Response to Occurrence of Relapse Defined as <50% of Baseline MADRS Score [ Time Frame: 6 months ]The length of time from post-infusion response until relapse (defined as >50% of MADRS baseline score) assessed for up to 6 months.
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): NCT02360280
|United States, Minnesota|
|Minneapolis VA Health Care System, Minneapolis, MN|
|Minneapolis, Minnesota, United States, 55417|
|Principal Investigator:||Paulo R Shiroma, MD||Minneapolis VA Health Care System, Minneapolis, MN|