Effect of supplementary oral 5-hydroxytryptophan on severity of depression in patients on chronic selective serotonin reuptake inhibitors; a clinical trial

Phase 2

• Conditions: Major depression; Mental Health - Depression; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12613001275752
• Lead Sponsor: Daniel F Fouladi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Patients with major depression on chronic (over 6 months) selective serotonin reuptake inhibitors

Exclusion Criteria

Patients on anti-depressive medications other than SSIRs, patients with carcinoids, renal disease, or malabsorption.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of depression according to the Beck Depression Inventory-II[baseline, month 3, month 6.];Quality of life according to the World Health Organization Quality of Life Questionnaire[baseline, month 3, month 6.];The level of urinary 5-Hydroxyindoleacetic acid (5-HIAA) using high- pressure liquid chromatography[Baseline, month 3.]

Secondary Outcome Measures

Name	Time	Method
Possible side effects/complications of SSIRs such as blurred vision, diarrhea/constipation, dizziness, dry mouth, feeling agitated or shaky, loss of appetite, excessive sweating, sexual problems, and sleep problems by asking from patients.[baseline, month 3, month 6.];Possible side effects/complications of 5-HTP supplement such as problems in appetite, sleep, sexual behavior, temperature and pain sensation by asking from patients.[baseline, month 3, month 6.]