evaluation of s-ketamine effects on reducing suicidal thoughts and behaviors in major depressive disorder
Phase 3
Recruiting
- Conditions
- Suicidal thoughts and behaviors.
- Registration Number
- IRCT20160105025859N1
- Lead Sponsor
- Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
This clinical trial study will be conducted in Ebne Sina and Hafez Hospital, Shiraz, Iran and all patients who are admitted to our medical care center during a one year period with complaints of suicidal ideas and with a diagnosis of DSM-5 major depressive disorder (MDD),
Exclusion Criteria
Those who have a positive history of alcohol or substance abuse during the past 6 months
mood disorders due to any medical conditions
pregnancy or lactation
those with a positive history of ketamine abuse
those with symptoms of psychosis
unstable medical conditions
with hypersensitivity to ketamine
positive history of use of psychotropic agents or drugs like corticosteroids
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Suicidal thoughts and behaviors. Timepoint: Patients will be evaluated at baseline (8 hours before infusion), 24 hours, 7 and 10 days and two weeks after each infusions of Es-Ketamine or Midazolam in both groups. Method of measurement: The Beck Scale for Suicide Ideation (BSSI).
- Secondary Outcome Measures
Name Time Method Es-Ketamine administration will reduce symptoms of patients with Major Depressive disorder 2weeks post infusion. Timepoint: before and 2 weeks after Es-Ketamine or Midazolam infusion. Method of measurement: Hamilton Rating Scale for Depression (HRSD).