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

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ClinicalTrials.gov Identifier: NCT01555970
Recruitment Status : Completed
First Posted : March 16, 2012
Last Update Posted : October 24, 2014
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Roseli Shavitt, University of Sao Paulo

Brief 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).

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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Serotonin Reuptake Inhibitor Augmentation With N-Acetylcysteine in Resistant Obsessive-compulsive Disorder: a Double-blind, Randomized and Controlled Study
Study Start Date : March 2012
Primary Completion Date : October 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Yale-Brown Obsessive-Compulsive Scale total score [ Time Frame: 16 weeks ]
    Percent reduction of baseline Y-BOCS total score at weeks 16 or at withdrawal from the study


Secondary Outcome Measures :
  1. Dimensional Yale-Brown Obsessive-Compulsive Scale score [ Time Frame: 16 weeks ]
    The mean change in DYBOCS scores at week 16 or at withdrawal from the study

  2. Clinical Global Impression Scale [ Time Frame: 16 weeks ]
    Global Improvement score of the Clinical Global Impression Scale measured at week 16 or at withdrawal from the study

  3. Beck Depression Inventory [ Time Frame: 16 weeks ]
    The mean change in Beck Depression Inventory scores measured at week 16 or at withdrawal from the study

  4. Beck Anxiety Inventory [ Time Frame: 16 weeks ]
    The mean change in Beck Anxiety Inventory scores measured at week 16 or at withdrawal from the study



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01555970


Locations
Brazil
Instituto de Psiquiatria do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, SP, Brazil, 01060-970
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roseli Shavitt, Psychiatrist, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01555970     History of Changes
Other Study ID Numbers: NACTOC
First Posted: March 16, 2012    Key Record Dates
Last Update Posted: October 24, 2014
Last Verified: October 2014

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

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