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Efficacy and safety of folic acid assisted sertraline in the treatment of patients with first-episode obsessive-compulsive disorder

Efficacy and safety of folic acid with sertraline in the treatment of patients with first-episode obsessive-compulsive disorder

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058311
Enrollment
Unknown
Registered
2022-04-05
Start date
2022-04-01
Completion date
Unknown
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obsessive-compulsive disorder(OCD)

Interventions

Experimental group:folic acid 5mg/d and sertraline 100-200mg/d
Control group:sertraline 50-200mg/d

Sponsors

Xi'an Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for obsessive-compulsive disorder of the American Diagnostic and Statistical Manual of Mental Disorders, Revised 5th Edition (DSM-V); 2. Total score of Yale-Brown Obsessive-compulsive Symptom Scale (YBOCS) >=16; 3. Aged 18-45 years; 4. Junior high school or above; 5. Han nationality; 6. Never received any psychiatric medication, physical or psychological treatment; 7. Voluntary participation in the study with the informed consent of the subject and/or their guardian; 8. Serum vitamin B12 level is normal.

Exclusion criteria

Exclusion criteria: 1. Obsessive-compulsive symptoms accompanied by psychotic symptoms; Obsessive-compulsive symptoms are secondary to other mental and physical diseases; 2. Patients with a history of suicide attempts or a high risk of suicide or suicidal behavior/attempts; 3. Previous or current mental illness; 4. A history of abuse of tobacco, alcohol and other psychoactive substances; 5. Pregnant or breastfeeding patients or those who plan to become pregnant within 3 months of the start of the trial; 6. Hamilton Depression Scale score (HAMD-17) >=12 points, Hamilton Anxiety Scale score (HAMA) >=14 points; 7. Patients who are allergic or allergic to two or more kinds of food or drugs; 8. Patients with a history of severe or poorly controlled cardiovascular disease, liver and kidney disease, blood disease, endocrine disease and respiratory disease.

Design outcomes

Primary

MeasureTime frame
Yale-brown Obsessive-compulsive Symptom Scale;Drug Side Effect Scale;

Countries

China

Contacts

Public ContactZhuang Rong

Xi'an Mental Health Center

zrxixixi@163.com+86 18089206798

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026