Escitalopram Plus PS128 vs. Escitalopram

NCT04093960 | Terminated Phase 4 DMC

• 1 other identifier: KSPH-2016-02
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression

Keywords

psychobiotics; major depressive disorder; escitalopram

Outcome Measures

Primary Outcomes (1)

• Depression severity by the change of 17-item Hamilton Rating Scale for Depression (HAMD-17) total scores

  17-item Hamilton Rating Scale for Depression (HAMD-17) is widely used in clinical setting to evaluate depression symptoms in the past week. Higher total HAMD-17 scores (ranging from 0 to 52) indicate more severe depression.

  Time Frame: The HAMD-17 was rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination).

Secondary Outcomes (18)

• Clinical severity by Clinical Global Impression-Severity (CGI-S)

  The scales were rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination).

• Assessments of safety for general adverse events

  The scales were rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination).

• Change of body weights

  Time Frame: Body weights were assessed at baseline and week 6(or on early termination).

• Change of body mass index (BMI)

  Time Frame: BMI was assessed at baseline and week 6(or on early termination).

• Change of pulse rate

  Time Frame: Pulse rates were checked at baseline and at weeks 1, 2, 3, 4, and 6 (or on early termination).

Study Arms (2)

escitalopram plus128

EXPERIMENTAL

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

Dietary Supplement: Lactobacillus plantarum PS128

escitalopram

ACTIVE COMPARATOR

10 mg/d of escitalopram

Dietary Supplement: Lactobacillus plantarum PS128

Interventions

Lactobacillus plantarum PS128 DIETARY_SUPPLEMENT

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

escitalopram; escitalopram plus128

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaohsiung Kai-Suan Psychiatric Hospital: lead

Study Sites (1)

Kaohsiung Municipal Kai-Syuan Psychiatric Hospital

Kaohsiung City, 886, Taiwan

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Adult Psychiatry

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: September 18, 2019
• Study Start: November 18, 2016
• Primary Completion: March 4, 2019
• Study Completion: September 1, 2019
• Last Updated: September 18, 2019

Record last verified: 2019-09

Locations

TW (1)