NCT01794897

Valacyclovir Augmentation for Cognitive and Functional Remediation in Schizophrenia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The effects of Valacyclovir (VAV) augmentation or placebo (PLA) as adjuncts to conventional antipsychotic drug treatment will be evaluated among patients with schizophrenia who have been exposed to herpes simplex virus type 1 (HSV-1). Hypothesis: Valacyclovir (VAV) augmentation improves (a) cognitive and (b) overall function among Herpes Simples Virus 1 (HSV-1) exposed early course schizophrenia patients.

Detailed description

Design: We propose a randomized double blind placebo controlled study of patients with early course Schizophrenia (SZ) / schizoaffective disorder (SZA) patients exposed to HSV-1, who are receiving antipsychotic drugs. The effects of VAV augmentation or PLA as adjuncts to conventional antipsychotic drug treatment will be evaluated. As outcomes, we will evaluate clinical symptoms, cognitive variables, overall function (including social function) and side effects. The participants will be under the direct care of the Indian investigators during the study. Ratings will be performed blind by research staff. We will pre-screen for HSV-1 exposure. There will be a 2 week placebo run in phase, 16 week augmentation and 4 week follow up to identify post-treatment side effects.

Conditions

• Herpes Simplex
• Schizophrenia
• Schizoaffective Disorder

Interventions

Type	Name	Description
DRUG	Experimental: Valacyclovir treatment	Patients will have a placebo run-in for two weeks after which they will be evaluated for the variables of interest and then randomized to either VAV or placebo group in a 1:1 proportion. The VAV group will receive 1.5 g Valacyclovir by mouth, twice daily for 16 weeks, after which they will be followed up without VAV for 4 weeks to monitor delayed adverse effects.
DRUG	Placebo comparator	Patients will have a placebo run-in for two weeks after which they will be evaluated for the variables of interest and then randomized to either VAV or placebo group in a 1:1 proportion. Subjects in the placebo arm will receive placebo for 16 weeks, after which they will be followed up without placebo for 4 weeks to monitor delayed adverse effects.

Timeline

• Start date: 2013-02-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2013-02-20
• Last updated: 2016-10-26

Locations

1 site across 1 country: India