NAC for Treatment-Resistant OCD and Other Related Disorders

NCT06956157 · tracked via the Priya Life Science China tracker

Sponsor

Guangdong Provincial People's Hospital

Phase

Phase 4

Started

2022-06-22

Last updated

2025-09-03

Condition(s) studied

Obsessive Compulsive Disorder (OCD)

Investigational drug(s) / intervention(s)

N-Acetylcysteine Tablets →Placebo Oral Tablet

N-Acetylcysteine Tablets: In addition to participants' existing medication regimens, NAC will be added.

Placebo Oral Tablet: Placebo oral tablets are identical in appearance (size, shape, color), packaging, taste, and administration schedule to the N-Acetylcysteine tablets to maintain blinding. The tablets contain inert excipients and no active pharmacological ingredients.

Study 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-OCD), studied within a broader cohort of treatment-resistant Obsessive-Compulsive and Related Disorders (OCRDs).

The study's primary aim is to investigate the neurobiological mechanism by which NAC improves inhibitory control deficits in TR-OCD. This is achieved by using Magnetic Resonance Spectroscopy (MRS) to measure changes in thalamic glutamatergic metabolism. A secondary aim is to assess the clinical efficacy of this augmentation strategy on symptom severity. The central hypothesis is that improvements in inhibitory control are mediated by NAC-induced changes in brain glutamate levels.

Eligibility

Sex

ALL

Min age

12 Years

Max age

55 Years

Healthy volunteers

Accepted

1.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. 1.2 Inclusion Criteria for Healthy Controls: (1) Age and sex-matched to the patient group. (2) No personal history of any psychiatric disorder. 1.3 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. 1.4 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.

Primary outcome measure(s)

Change from Baseline in Neurometabolite Concentrations in Key Brain Regions — Baseline, Post-treatment (Week 12)
Change from baseline to Week 12 in the concentrations of Glutamate (Glu), Glutamate+Glutamine (Glx), and Glutathione (GSH) within two pre-specified regions of interest: the thalamus and the anterior cingulate cortex (ACC). Levels are measured in both resting and functional states using Magnetic Resonance Spectroscopy (MRS).
Change from Baseline in Inhibitory Control Performance — Baseline, Post-treatment (Week 12)
Change from baseline to Week 12 in inhibitory control performance, as measured by the error rate on a Go-Nogo task. A decrease in the error rate indicates improvement.

Trial sites (1)

Facility	City	Region	Status
Guangdong Mental Health Center, Guangdong Provincial People's Hospital	GuangDong	Guangdong

More Guangdong Provincial People's Hospital trials in China

Association Between RVT and Prognosis After Neoadjuvant Targeted Therapy in EGFR NSCLC Recruiting

Safety and Effectiveness of Early Aspirin Administration After Mitral Valve Repair Recruiting

Evaluation of Pressurized Intraperitoneal Aerosol Chemotherapy With VRT106 Versus PIPAC in Patients With Advanced Gastric Cancer and PeritonealMetastasis: A Prospective, Multicenter, Open-Label, Randomized Controlled Trial Starting soon

Neoadjuvant Almonertinib Followed by Chemo-immunotherapy in II-IIIB EGFR-mutant NSCLC Active, not recruiting

The Safety and Efficacy of Autologous Transfusion in Spinal Surgery for Lung Cancer With Spinal Metastasis Recruiting

Other trials for the same condition

Exploring the Efficacy of Accelerated Transcranial Direct Current Stimulation (tDCS) as Adjunct to Pharmacotherapy in the Treatment of Obsessive-compulsive Disorder Starting soon

Accelerated rTMS Therapeutic Approach for Refractory Obsessive-Compulsive Disorder Recruiting

Efficacy and Mechanism of Augmentation of Cognitive Behavioral Therapy With Transcranial Alternating Current Stimulation(tACS) for Obsessive-Compulsive Disorder (OCD) Recruiting

The Effects and Neural Mechanisms of Vitamin D and Iron-Immune Homeostasis on Inhibitory Control in Obsessive-Compulsive Disorder Enrolling by invitation

Transcutaneous Electrical Acupoint Stimulation Combined With Exposure and Response Prevention in the Treatment of Patients With Obsessive-Compulsive Disorder: A Randomized Controlled Trial Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06956157 on ClinicalTrials.gov ↗ ← All trials in China