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

NCT01555970 | Completed Phase 2

• 1 other identifier: NACTOC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Obsessive-Compulsive Disorder

Keywords

Obsessive-compulsive disorder; Treatment; Glutamate; N-Acetylcysteine

Outcome Measures

Primary Outcomes (1)

• Yale-Brown Obsessive-Compulsive Scale total score

  Percent reduction of baseline Y-BOCS total score at weeks 16 or at withdrawal from the study

  16 weeks

Secondary Outcomes (4)

• Dimensional Yale-Brown Obsessive-Compulsive Scale score

  16 weeks

• Clinical Global Impression Scale

  16 weeks

• Beck Depression Inventory

  16 weeks

• Beck Anxiety Inventory

  16 weeks

Study Arms (2)

NAC

EXPERIMENTAL

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)

Placebo

PLACEBO COMPARATOR

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

Interventions

N-Acetylcysteine (NAC) DRUG

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)

NAC

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary signed informed consent prior to the performance of any study specific procedures
• 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
• OCD symptoms at least of one year's duration and of least moderate severity on the Clinical Global Impression Scale (CGI).

You may not qualify if:

• Psychiatric diagnosis of a primary psychotic disorder
• Hepatitis or any liver disease
• Patients who have had psychosurgery
• Recent (\<1 month) change in psychotropic medications
• Presence of clinically significant somatic disease and/or medical problem that requires frequent changes in medication.
• History of or current diagnosis of seizure disorder
• Evidence of Substance Use Disorder (DSM-IV) within past 1 months or current illicit drug use.
• Active Suicidal Ideation
• Patients who have been previously exposed to N-acetylcysteine.
• Women who are pregnant, lactating, or of childbearing potential (not sterile nor using reliable birth control).

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Instituto de Psiquiatria do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, 01060-970, Brazil

Location

Related Publications (1)

• Costa DLC, Diniz JB, Requena G, Joaquim MA, Pittenger C, Bloch MH, Miguel EC, Shavitt RG. Randomized, Double-Blind, Placebo-Controlled Trial of N-Acetylcysteine Augmentation for Treatment-Resistant Obsessive-Compulsive Disorder. J Clin Psychiatry. 2017 Jul;78(7):e766-e773. doi: 10.4088/JCP.16m11101.

  PMID: 28617566 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Daniel Costa, MD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Roseli Shavitt, PhD

  University of Sao Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist

Study Record Dates

• First Submitted: March 14, 2012
• First Posted: March 16, 2012
• Study Start: March 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 24, 2014

Record last verified: 2014-10

Locations

BR (1)