Escitalopram Plus PS128 vs. Escitalopram

NCT ID: NCT04093960

Last Updated: 2019-09-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-18
• Study Completion Date: 2019-09-01

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.

Conditions

Major Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

escitalopram plus128

escitalopram (10 mg daily) plus PS128(a psychobiotic) (300 mg two times daily, equivalent to 3 ×1010 CFU two times daily)

Group Type: EXPERIMENTAL

Lactobacillus plantarum PS128

Intervention Type: DIETARY_SUPPLEMENT

10 mg qd of escitalopram qd plus 300mg bid of Lactobacillus plantarum PS128 to enhance antidepressive effect

escitalopram

10 mg/d of escitalopram

Group Type: ACTIVE_COMPARATOR

Lactobacillus plantarum PS128

Intervention Type: DIETARY_SUPPLEMENT

10 mg qd of escitalopram qd plus 300mg bid of Lactobacillus plantarum PS128 to enhance antidepressive effect

Interventions

Lactobacillus plantarum PS128

10 mg qd of escitalopram qd plus 300mg bid of Lactobacillus plantarum PS128 to enhance antidepressive effect

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaohsiung Kai-Suan Psychiatric Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ching-Hua Lin, MD, PhD

Chief of Adult Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kaohsiung Municipal Kai-Syuan Psychiatric Hospital

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

KSPH-2016-02

Identifier Type: -

Identifier Source: org_study_id