Immunological response to Hepatitis B vaccination in obsessive compulsive disorder patients receiving high doses of serotonin reuptake inhibitors

Phase 4

Completed

• Conditions: drug-induced immunosuppression; 10027665; 10002861

• Registration Number: NL-OMON38586
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Primary diagnosis: obsessive compulsive disorder according to DSM-IV criteria based on a psychiatric interview
Age: 18-40 years old
Female
Body mass index (BMI) < 25
Treated with 60 mg/d paroxetine (group 1) or not taking any serotonergic medication (group 2)
Written informed consent
Dutch or English speaking and able to answer the study questions
Capable to make his or her own choice without coercion

Exclusion Criteria

Previous hepatitis B vaccination or hepatitis B infection
Suffering from auto-immune disease such as rheumatoid arthritis, lupus erythematosus etc.
A weakened immune system, due to conditions such as HIV
Kidney and/or liver diseases
The use of immunosuppressive medication such as corticosteroids, methotrexate, cyclosporine

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary research variables are<br /><br>1) antibody titers to hepatitis B virus (anti-HBs) and<br /><br>2) the cellular (T-cell) response to soluble hepatitis B antigen (HBsAg). The<br /><br>number of cytokine-producing cells (IFNy, TNFa and IL2) will be determined, as<br /><br>well as the HBsAg-specific T-cell proliferation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>