Status:
RECRUITING
Psychopharmacotherapy for Depressive Patients
Lead Sponsor:
Chonnam National University Hospital
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
19-65 years
Phase:
NA
Brief Summary
The primary purpose of this study is to compare the short (12 week) and long-term (1-year) efficacy and the tolerability between stepwise psychopharmacotherapy and antidepressant monotherapy for 12 we...
Detailed Description
This is prospective randomized controlled trials (RCT) to evaluate clinical impact of antidepressant monotherapy vs stepwise psychopharmacotherapy in patients with major depressive disorders, stratifi...
Eligibility Criteria
Inclusion
- 19 to 65 years
- Diagnostic and Statistical Manual of Mental Disorders-IV criteria for major depressive disorder by study psychiatrists
- Score≥17 on Hamilton Depression Rating Scale-17
- With ability to understand the objective of the study and sign informed consent
- Initiation of an antidepressant treatment for the current episode or no psychotropics excluding sleep pills or benzodiazepines within 1 month of participation
Exclusion
- Current or lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, psychotic disorder not otherwise specified, or other psychotic disorders
- current major depressive disorder with psychotic features
- History of organic psychosis, epilepsy, or seizure disorder
- Current anorexia nervosa or obsessive compulsive disorder
- Unstable or uncontrolled medical condition
- Unable to complete the psychiatric assessment or comply with the medication regimen due to a severe physical illness
- History of anticonvulsant treatment
- Electroconvulsive therapy for the current depressive episode
- Hospitalization for any psychiatric diagnosis except depressive disorder (e.g., alcohol/drug dependence)
- severly high risk of suicide, self-harm or homicide by investigator's assessment
- Pregnant or breastfeeding
- lack of treatment information on the current depressive episode
Key Trial Info
Start Date :
August 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06054321
Start Date
August 3 2022
End Date
December 31 2030
Last Update
April 18 2024
Active Locations (1)
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1
Chonnam National University Hospital
Gwangju, South Korea, 61469