Add-on treatment of mental illness with anti-viral medicine

• Conditions: Schizophrenia, bipolar disorder

• Registration Number: EUCTR2006-006940-69-SE
• Lead Sponsor: und University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-02
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

The patient:
(a) has schizophrenia (DSM-IV diagnostic code 295) or bipolar illness (DSM-IV 296.0x, 296.40/x, 296.5x, 296.6x, 296.7, 296.89),
(b) is 18-55 years old at inclusion,
(c) has a psychosis and treatment that are in a stabile phase (maximum 25%
variation in neuroleptic dose during the last 3 months prior to inclusion in the study),
(d) has a PANSS (Positive And Negative Symptom Scale) [20] total score of at least 50 at inclusion,
(e) is sero-positive (IgG) for herpes simplex-virus type 1 (HSV1), herpes simplex-virus type 2 (HSV2) and/or cytomegalo-virus (CMV).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The patient has:
(g) psychosis resulting from substance abuse or somatic illness,
(h) mental handicap or the inability to complete neuropsychological testing,
(i) known over-sensitivity or allergy to (val)acyclovir,
(j) immune deficiency illness/HIV/AIDS,
(k) on-going active herpes infection (temporary exclusion),
(l) another somatic condition that implies risk for a negative somatic effect of valacyclovir,
(m) on-going pregnancy or risk for pregnancy (in female patients),
(n) notable psychosis symptom improvement (i.e. >20% lower PANSS total score) during the 2 week run-in period with placebo.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study whether 16 weeks' add-on treatment with anti-viral medicine (valacyclovir), compared to placebo, reduces psychosis symptoms (at week 18) in patients with schizophrenia or bipolar disorder who previously have had a herpes 1-, herpes 2- and/or cytomegalo-virus infection.;Secondary Objective: Whether this anti-viral add-on treatment (1) reduces neurological deviations, (2) improves cognitive performance and the total illness picture (including functioning in everyday life), and (3) reduces signs of retroviral activity in the blood (at week 18).<br>;Primary end point(s): Change in total PANSS-points (Positive and Negative Symptom Scale [20]) from week 0 to week 18 (the measurements at weeks 2, 4, 6, 10 & 14 are ’control stations’ for charting the effect course).