Clinical trial NCT06956157: Neuroimaging Study of N-acetylcysteine in Excoriation (Skin-Picking) Disorder
Official title: Glutamatergic Modulation of Impaired Inhibitory Control in Skin Picking and Compulsive Behaviors: A Neural Mechanism Investigation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Obsessive Compulsive Disorder (OCD)
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2025-05-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical study is to understand the brain mechanisms, particularly involving glutamate metabolism and inhibitory control networks, that underlie Skin Picking Disorder (SPD) and differ from those in Obsessive-Compulsive Disorder (OCD) . It also aims to explore the effects of N-acetylcysteine (NAC) on these brain mechanisms in adults with SPD and identify potential imaging biomarkers. The main questions it aims to answer are:

How do neuro-metabolism (specifically glutamate measured by Magnetic Resonance Spectroscopy - MRS), brain activity and connectivity (measured by functional MRI - fMRI) differ between SPD, OCD, and healthy controls, particularly in relation to behavioral and cognitive inhibitory control deficits? Is there a relationship between glutamate abnormalities in the anterior cingulate cortex and impaired inhibitory control in SPD and OCD? Does 12 weeks of NAC treatment alter glutamate levels, brain function, or connectivity in SPD?

SPD receiving NAC will:

Participants will receive NAC tablets. Treatment will commence at a starting dose of 1800 mg per day. The dosage will be gradually increased over the initial 2 weeks with a target dose of 3000 mg per day. The daily dose will be administered in two divided doses (1500 mg twice daily at the target dose).


Eligibility criteria: Inclusion Criteria:

* Age between 18-49 years;
* Y-BOCS and NE-YBOCS total scores \< 6; Hamilton depression scale-17 total score ≤ 7;
* Han Chinese ethnicity, right-handed, education level of middle school or above;
* Signed informed consent.

Exclusion Criteria:

* Major physical illnesses, craniocerebral trauma, history of neurological or psychiatric disorders;
* Pregnant women;
* Family history of psychiatric disorders;
* History of alcohol or substance abuse;
* Currently meeting any psychiatric diagnostic criteria according to CCMD-3 and DSM-5;
* Any contraindications for MRI scanning.

Primary outcomes:
measure: Change in Anterior Cingulate Cortex (ACC) Neurometabolite Concentrations
timeFrame: Baseline, Post-treatment (Week 12)
measure: Change in Brain Functional Connectivity and Gray Matter Density Metrics
timeFrame: Baseline, Post-treatment (Week 12)
measure: Association Between Task-Activated Glutamate Dynamics and Functional/Behavioral Measures
timeFrame: Baseline, Post-treatment (Week 12)
Secondary outcomes:
measure: Yale-Brown Obsessive Compulsive Scale modified for Neurotic Excoriation
timeFrame: Baseline, Week 4, Week 8, Week 12
Other outcomes:
Locations:
city: GuangDong
country: China
facility: Guangdong Mental Health Center, Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Huirong Zheng, MD
role: PRINCIPAL_INVESTIGATOR
References: