Escitalopram Plus PS128 vs. Escitalopram

Kaohsiung Kai-Suan Psychiatric Hospital

Status and phase: Terminated; Phase 4

Conditions: Major Depression

Treatments: Dietary Supplement: Lactobacillus plantarum PS128

Study type: Interventional

Funder types: Other

Identifiers

NCT04093960

KSPH-2016-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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41 participants in 2 patient groups

escitalopram plus128

Experimental group

Description:

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

Treatment:

Dietary Supplement: Lactobacillus plantarum PS128

escitalopram

Active Comparator group

Description:

10 mg/d of escitalopram

Treatment:

Dietary Supplement: Lactobacillus plantarum PS128