Neuroimaging Study of N-acetylcysteine in Excoriation (Skin-Picking) Disorder

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status and phase: Active, not recruiting; Phase 4

Conditions: Obsessive Compulsive Disorder (OCD)

Treatments: Drug: N-Acetylcysteine Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT06956157

2021A1515011431 (Other Grant/Funding Number)

KY2020-572

Details and patient eligibility

About

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).

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

90 participants in 3 patient groups

SPD Group

Experimental group

Description:

NAC (N-Acetylcysteine Tablets, brand name: Flumucil) has a drug specification of 600 mg per tablet. In the first week, participants took 1200mg/d (one tablet three times daily: morning, noon, and evening). Starting from the second week until the end of the 12-week study, they took 3600mg/d (three tablets twice daily: morning and evening).

Treatment:

Drug: N-Acetylcysteine Tablets

OCD Group

No Intervention group

Healthy Control Group

No Intervention group