Status:
COMPLETED
N-acetylcysteine (NAC) for Pediatric Obsessive-Compulsive Disorder
Lead Sponsor:
Yale University
Conditions:
Obsessive-Compulsive Disorder
Eligibility:
All Genders
8-17 years
Phase:
PHASE2
Brief Summary
Pediatric Obsessive-Compulsive Disorder (OCD) affects 1-3% of children. The investigators currently have effective first-line interventions for pediatric OCD such as Cognitive Behavioral Therapy (CBT)...
Eligibility Criteria
Inclusion
- Children aged 8-17 years.
- Primary diagnosis of OCD.
- Duration of OCD greater than 6 months.
- Significant Current OCD symptoms: Current CY-BOCS score \> or = 16.
Exclusion
- Comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or mental retardation (IQ\<70).
- Recent change (less than 4 weeks) in medications that have potential effects on OCD severity (such as Selective Serotonin Reuptake Inhibitors, clomipramine, naltrexone, lithium, psychostimulants, anxiolytics, or antipsychotics). Medication change is defined to include either dose changes or medication discontinuation.
- Recent change in behavioral treatment for OCD or comorbid conditions within the last 4 weeks or initiation of behavioral therapy for tics within the last 12 weeks.
- Asthma requiring medication use within the last 3 months (case reports have linked intravenous NAC administration with asthma exacerbation)
- Known hypersensitivity or previous anaphylactoid reaction to acetylcysteine or any components in its preparation.
- Positive pregnancy test or drug screening test.
- Previous use of N-acetylcysteine (dose greater than 600mg for more than 2 weeks).
- Previous history or suspicion of cystinuria because of a possibility of forming kidney stones.
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2018
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01172275
Start Date
July 1 2012
End Date
February 15 2018
Last Update
September 6 2019
Active Locations (1)
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1
Yale Child Study Center
New Haven, Connecticut, United States, 06520