A nutrient combination in the treatment of Obsessive-Compulsive Disorder

Phase 1

Completed

• Conditions: Treatment-Refractory Obsessive-Compulsive Disorder; Mental Health - Other mental health disorders; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12617001140347
• Lead Sponsor: Prof Jerome Sarris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-04
• Study Completion: 2020-05-25
• Last Update Posted: 22 February 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

*18-75 years of age
*Y-BOCS score of equal to or greater than 16 at time of entry into the study
*Treatment-Refractory OCD (defined as inadequate response to 1. at least 3 trials to serotonin-reuptake inhibitor medications; 2. an augmentation trial, for example, an antipsychotic medication; 3. at least 15 sessions of cognitive and/or behavioural therapy with an experienced clinician OR completion of one in-patient program specific for OCD treatment.
*Stable treatment for the previous 4 weeks (for example, consistent doses of medications used for their OCD, regular appointments with psychologist for behavioural therapy) OR not currently employing treatment for their OCD

Exclusion Criteria

*Diagnosis of bipolar disorder
*Diagnosis of psychotic disorder
*Strong suicidal ideation (defined as Hamilton Depression rating scale, item-3 score equal to or greater than 3)
*Diagnosis of alcohol or substance abuse
*Medications with known or suspected interactions with any of the investigated nutrients, to be determined by the medical investigators on a case by case basis
*Allergy to any component of the investigational products
*Serious or unstable medical conditions, to be determined by the medical investigators on a case by case basis
*Gastrointestinal ulcers or renal stones within the last 2 years
*Pregnancy of women currently breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)[Administered at baseline, Week-4, Week-8, Week-12, Week-16 and Week-20 end point]

Secondary Outcome Measures

Name	Time	Method
Beck Anxiety Inventory (self-reported measure)[Baseline, Week-4, Week-8, Week-12, Week-16, Week-20];Dimensional Obsessive-Compulsive Scale (DOCS)[Baseline, Week-4, Week-8, Week-12, Week-16, Week-20];World Health Organisation Quality of Life questionnaire (Brief)[Baseline, Week-12 and Week-20];Clinician Global Impression (CGI) scale[Baseline, Week-4, Week-8, Week-12, Week-16, Week-20];Patient Global Impression (PGI) scale[Baseline, Week-4, Week-8, Week-12, Week-16, Week-20];The Structured Interview Guide for the Hamilton Depression Rating Scale (17 item)[Baseline, Week-4, Week-8, Week-12, Week-16, Week-20]