Valacyclovir Augmentation for Cognitive and Functional Remediation in Schizophrenia

University of Pittsburgh

Status and phase: Completed; Phase 4

Conditions: Herpes Simplex; Schizophrenia; Schizoaffective Disorder

Treatments: Drug: Experimental: Valacyclovir treatment; Drug: Placebo comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT01794897

PRO11120013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 134 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Written informed consent.
• Both genders, ages 18-50 years
• Schizophrenia / schizoaffective disorder (DSM IV).
• Stable dose of antipsychotic for > 1 month, continued throughout the study.
• Score 4 or more on one or more items of the Positive and Negative Syndrome Scale.
• Exposed to HSV-1: serum antibody assays.

Exclusion criteria

• Substance abuse in the past month/dependence past 6 months.
• History / current medical /neurological illnesses e.g., epilepsy.
• Pregnancy.
• History of immune disorders, HIV infection, or receiving immune-suppressants.
• Receiving regular antiviral therapy.
• History of hypersensitivity to Valacyclovir.
• Mental retardation as defined in DSM IV.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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134 participants in 2 patient groups, including a placebo group

Valacyclovir treatment

Experimental group

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 Valacyclovir (VAV) or placebo (PLA) 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.

Treatment:

Drug: Placebo comparator

Drug: Experimental: Valacyclovir treatment

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo comparator