ACTRN12617001140347
Completed
Phase 1
Treatment of Refractory Obsessive-Compulsive Disorder with Nutraceuticals
Prof Jerome Sarris0 sites28 target enrollmentAugust 4, 2017
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Treatment-Refractory Obsessive-Compulsive Disorder
- Sponsor
- Prof Jerome Sarris
- Enrollment
- 28
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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