Efficacy Study of add-on Therapy With N-Acetylcysteine in Resistant Obsessive-compulsive Disorder

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to determine if N-Acetylcysteine (NAC) has efficacy as an augmentation agent in the treatment of treatment-resistant obsessive-compulsive disorder (OCD). The investigators predict that NAC will reduce OCD symptoms after sixteen weeks of add-on treatment as measured by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo
• Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Treatments: Acetylcysteine; N-monoacetylcystine; Serotonin Uptake Inhibitors

Criteria

Inclusion Criteria:

1. Voluntary signed informed consent prior to the performance of any study specific procedures

2. A DSM-IV primary diagnosis of OCD that has failed to clinically respond, as defined by a Y-BOCS score of greater than 16, to at least one first-line adequate treatments, like:

• SRI

• CBT

• SRI + CBT

• SRI + atypical antipsychotic

3. OCD symptoms at least of one year's duration and of least moderate severity on the Clinical Global Impression Scale (CGI).

Exclusion Criteria:

1. Psychiatric diagnosis of a primary psychotic disorder

2. Hepatitis or any liver disease

3. Patients who have had psychosurgery

4. Recent (<1 month) change in psychotropic medications

5. Presence of clinically significant somatic disease and/or medical problem that requires frequent changes in medication.

6. History of or current diagnosis of seizure disorder

7. Evidence of Substance Use Disorder (DSM-IV) within past 1 months or current illicit drug use.

8. Active Suicidal Ideation

9. Patients who have been previously exposed to N-acetylcysteine.

10. Women who are pregnant, lactating, or of childbearing potential (not sterile nor using reliable birth control).