A longitudinal study of the N-Acetylcysteine treatment for the obsessive compulsive disorder (LNSFC)

JRCT ID: jRCTs051180040

Registered date:30/01/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: obsessive-compulsive disorder
• Date of first enrollment: 25/09/2019
• Target sample size: 30
• Study type: Interventional
• Intervention(s): a 12-week intervention period of N-acetylcysteine (up to 2400 mg/d)

Outcome(s)

• Primary Outcome: The strength of functional and structural connectivity from the orbitofrontal cortex to the ventral striatum measured by analyzing the functional brain images and the diffusion tensor images.
• Secondary Outcome: The severity of obsessive-compulsive symptoms (measured by Y-BOCS), the serum concentrations of 5-HT, dopamine, glutamate and their precursors, metabolites.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

(Patients)
(1) Men and women aged 20 to 65 years with a primary diagnosis of obsessive-compulsive disorder(OCD), recruited at the Kyoto Prefectural University of Medicine Hospital, Kyoto, Japan.
(2) Without significant disease except OCD and related disorders, depressive disorders, anxiety disorders, autism spectrum disorders, attention-deficit/hyperactivity disorders and tic disorders.
(3) The history of treatment failure defined as Y-BOCS score of 16 or greater after at least 12 weeks of serotonin reuptake inhibitor (SRI) treatment.
(4) With the ability of giving written, informed consent after receiving a complete description of the study.
(5) Matching the conditions of (1)-(4).

(Healthy controls)
(1)Men and women aged 20 to 65 years , matched for age and sex with the patient group, without history of psychiatric illness determined by the Structured Clinical Interview for DSM-IV AxisI Disorders, Non-patient Edition(SCID-NP).
(2) With the ability of giving written, informed consent after receiving a complete description of the study.
(3) Matching the conditions of (1)-(2).

Exclude criteria

(1) Cardiac pacemakers or other metallic implants or artifacts influenced by the magnetic resonance imaging devices with the high magnetic fields
(2) Faculty members belonging to the same affiliations with the investigator and the subinvestigators, or students belonging to the University hospital Kyoto prefectural university of medicine
(3) Current and past history of N-Acetylcysteine treatment
(4) Other conditions we judge as inappropriate as subjects.

Related Information

• Primary Sponsor: Nakamae Takashi