The effect of probiotic supplement on depression severity

Phase 3

• Conditions: Depression.; Depressive episode

• Registration Number: IRCT201601102394N20
• Lead Sponsor: Research Center of Iran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Inclusion Criteria: Patients with major depressive according to DSM-IV-TR criteria that they have not use any supplement and antidepressant drug at least 2 months prior to the start of the project; aged 18 to 65 years; at least score 15 on Hamilton Depression Rating Scale 17 (HDRS-17).

Exclusion Criteria

Pregnancy and lactation; drug abuse within 6 months prior to the start of the project; psychosis; any type of severe chronic physical illness and any extreme and severe mental disorders (suicidal ideation, psychotic symptoms, symptoms of manic phase, etc)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Depression severity. Timepoint: begining, end of forth week, end of intervention. Method of measurement: Hamilton Depression Rating Scale.;BDNF. Timepoint: begining, end of intervention. Method of measurement: ELIZA.;Cortisol. Timepoint: begining, end of intervention. Method of measurement: ELIZA.;ACTH. Timepoint: begining, end of intervention. Method of measurement: electrocemiLuminescence.

Secondary Outcome Measures

Name	Time	Method
Side effect. Timepoint: end of forth week, end of intervention. Method of measurement: side effect questionnaire.;Energy intake. Timepoint: begining, end of intervention. Method of measurement: 24-hour recall.;Physical activity. Timepoint: begining, end of intervention. Method of measurement: IPAQ questionnaire.