Valacyclovir Augmentation for Cognitive and Functional Remediation in Schizophrenia

Sponsor
University of Pittsburgh
Study ID
NCT01794897
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Experimental: Valacyclovir treatment — DRUG
    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.
  • Placebo comparator — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 28, 2013
Status verified
Oct 2016
Primary completion
Sep 30, 2016
Completion
Sep 30, 2016

Study Design

Enrollment
134 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Valacyclovir treatment
    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.
  • Placebo Comparator: Placebo
    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.

Primary Outcome Measure

Cognition [ Time Frame: Assessed at week 16 ]

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