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

This study is currently recruiting participants.
Verified June 2012 by University of Sao Paulo
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Roseli Shavitt, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01555970
First received: March 14, 2012
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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).


Condition Intervention Phase
Obsessive-Compulsive Disorder
Drug: N-Acetylcysteine (NAC)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Serotonin Reuptake Inhibitor Augmentation With N-Acetylcysteine in Resistant Obsessive-compulsive Disorder: a Double-blind, Randomized and Controlled Study

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Yale-Brown Obsessive-Compulsive Scale total score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Percent reduction of baseline Y-BOCS total score at weeks 16 or at withdrawal from the study


Secondary Outcome Measures:
  • Dimensional Yale-Brown Obsessive-Compulsive Scale score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    The mean change in DYBOCS scores at week 16 or at withdrawal from the study

  • Clinical Global Impression Scale [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Global Improvement score of the Clinical Global Impression Scale measured at week 16 or at withdrawal from the study

  • Beck Depression Inventory [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    The mean change in Beck Depression Inventory scores measured at week 16 or at withdrawal from the study

  • Beck Anxiety Inventory [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    The mean change in Beck Anxiety Inventory scores measured at week 16 or at withdrawal from the study


Estimated Enrollment: 40
Study Start Date: March 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NAC
Patients allocated in this group will receive N-acetylcysteine 1200 mg (one 600 mg capsule twice a day) during the first week of the study. On day 8 this will increase to 4 capsules per day (2400 mg NAC; 2 capsules twice a day). Finally, on day 15 (after 1 week at 2400 mg) the dose will be increased to the target dose of 5 capsules per day (3000 mg; 2 capsules in the morning and 3 in the evening), at which dose it will be continued for the remainder of the study.
Drug: N-Acetylcysteine (NAC)
Week 1: 1200 mg (one 600 mg capsule twice a day) Week 2: 2400 mg (two 600 mg capsules twice a day) Weeks 3-16: 3000 mg (two 600 mg capsules in the morning and 3 in the evening)
Placebo Comparator: Placebo
Patients allocated in this group will receive one capsule of placebo twice a day during the first week of the study. On day 8 this will increase to 4 capsules per day (2 capsules twice a day). Finally, on day 15 the dose will be increased to the target dose of 5 capsules per day (2 capsules in the morning and 3 in the evening), at which dose it will be continued for the remainder of the study.
Drug: Placebo
Week 1: one capsule twice a day Week 2: two capsules twice a day Weeks 3-16: two capsules in the morning and 3 in the evening

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 two first line adequate treatments, like:

    • 2 different SRIs (one at a time)
    • CBT alone
    • 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 Ideations
  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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555970

Contacts
Contact: Daniel Costa, MD +55 11 2661-6972 danielcosta228@yahoo.com.br

Locations
Brazil
Instituto de Psiquiatria do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo Recruiting
São Paulo, SP, Brazil, 01060-970
Contact: Daniel Costa, MD    +55 11 2661-6972    danielcosta228@yahoo.com.br   
Principal Investigator: Daniel Costa, MD         
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Daniel Costa, MD University of Sao Paulo
Study Chair: Roseli Shavitt, PhD University of Sao Paulo
  More Information

No publications provided

Responsible Party: Roseli Shavitt, Psychiatrist, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01555970     History of Changes
Other Study ID Numbers: NACTOC
Study First Received: March 14, 2012
Last Updated: June 12, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
Obsessive-compulsive disorder
Treatment
Glutamate
N-Acetylcysteine

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders
Acetylcysteine
N-monoacetylcystine
Serotonin Uptake Inhibitors
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Serotonin Agents

ClinicalTrials.gov processed this record on April 17, 2014