Status:
TERMINATED
Escitalopram Plus PS128 vs. Escitalopram
Lead Sponsor:
Kaohsiung Kai-Suan Psychiatric Hospital
Conditions:
Major Depression
Eligibility:
All Genders
20-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the efficacy and safety of escitalopram plus PS128 to escitalopram in the acute treatment of patients with major depressive disorder.
Detailed Description
In this 6-week, double-blind, fixed-dose study, patients with major depressive disorder are randomly assigned to escitalopram (10 mg daily) plus PS128 (a psychobiotic) (300 mg two times daily, equival...
Eligibility Criteria
Inclusion
- Major depressive disorder
- CGI \>=4
- the score of the 17-item Hamilton Rating Scale for Depression (HAMD-17) was 18 or higher.
- washout of antipsychotics at least 3 days
- written informed consents
- Not taking fluoxetine at least one month before admission.
Exclusion
- History of schizophrenia, schizoaffective disorder or organic mental disorders.
- comorbid with substance abuse/dependence in the past 6 months.
- with psychotic features
- treatment-resistant depression or receiving electroconvulsive therapy.
- History of serious adverse events to escitalopram
- female subjects with pregnancy or lactation.
- severe physical illness
- receiving antibiotics treatment in the past two weeks.
- taking products with probiotics.
Key Trial Info
Start Date :
November 18 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04093960
Start Date
November 18 2016
End Date
September 1 2019
Last Update
September 18 2019
Active Locations (1)
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1
Kaohsiung Municipal Kai-Syuan Psychiatric Hospital
Kaohsiung City, Taiwan, 886