Status:
ACTIVE_NOT_RECRUITING
NAC for Treatment-Resistant OCD and Other Related Disorders
Lead Sponsor:
Guangdong Provincial People's Hospital
Conditions:
Obsessive Compulsive Disorder (OCD)
Eligibility:
All Genders
12-55 years
Phase:
PHASE4
Brief Summary
This is a randomized, double-blind, placebo-controlled study investigating N-acetylcysteine (NAC) as an augmentation therapy for individuals with treatment-resistant obsessive-compulsive disorder (TR-...
Detailed Description
Please note: This study was initially designed to investigate the effects of N-acetylcysteine (NAC) across the broader spectrum of treatment-resistant Obsessive-Compulsive and Related Disorders (OCRDs...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Patient:
- (1) Age between 12 and 55 years. (2) A primary diagnosis of OCD according to DSM-5 criteria. (3) Excoriation (Skin-Picking) Disorder (SPD) according to DSM-5 criteria.
- (4) Met criteria for treatment resistance, defined as: (a) A Y-BOCS score ≥ 16. (b) A history of inadequate response (\<25% reduction in Y-BOCS score) to at least two different serotonin reuptake inhibitors (SSRIs) at an adequate dose for at least 12 weeks each.
- 2 Inclusion Criteria for Healthy Controls:
- (1) Age and sex-matched to the patient group. (2) No personal history of any psychiatric disorder.
- 3 Exclusion Criteria for All Participants: (1) Presence of any contraindications to 3T MRI scanning (e.g., metallic implants, claustrophobia). (2) Current (within the past 6 months) diagnosis of a substance use disorder. (3) Significant or unstable neurological illness (e.g., epilepsy, multiple sclerosis, brain tumor). (4) History of significant head trauma or neurosurgery.
- 4 Additional Exclusion Criteria for Patients with TR-OCD:
- (1) Current or lifetime diagnosis of a primary psychotic disorder (e.g., schizophrenia), bipolar I/II disorder, or intellectual disability. (2) Any contraindication to the use of N-acetylcysteine.
Exclusion
Key Trial Info
Start Date :
June 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 13 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06956157
Start Date
June 22 2022
End Date
November 13 2025
Last Update
September 3 2025
Active Locations (1)
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1
Guangdong Mental Health Center, Guangdong Provincial People's Hospital
GuangDong, Guangdong, China, 510120