Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-27 @ 8:22 AM
Study NCT ID:
NCT04093960
Status:
TERMINATED
Last Update Posted:
2019-09-18
First Post:
2019-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Escitalopram Plus PS128 vs. Escitalopram
Sponsor:
Kaohsiung Kai-Suan Psychiatric Hospital
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Comparison of the Efficacy and Safety of Escitalopram Plus PS128 to Escitalopram in the Acute Treatment of Patients With Major Depressive Disorder
Status:
TERMINATED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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, equivalent to 3 ×1010 CFU two times daily) or escitalopram (10 mg daily) groups. The rating scales and instrument, including Clinical Global Impression-Severity, 17-item Hamilton Rating Scale for Depression, Hamilton Anxiety Rating Scale, Global Assessment of Functioning, Heart Rate Variability, Depression and Somatic Symptoms Scale, Work and Social Adjustment Scale, Short form 36 and Pittsburgh Sleep Quality Index, are used to measure treatment outcomes at weeks 0, 1, 2, 3, 4, 5, and 6. UKU Side Effect Rating Scale and Gastrointestinal Symptom Rating Scale-Irritable Bowel Syndrome are used to measure side effects. Generalized estimating equations model will be used to analyze the differences between two groups with respect to efficacy and safety measures on time after adjusting for baseline severity, sex, age and age at onset of illness.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: