Systematic Evaluation of Antiviral Medication in Schizophrenia

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Konasale Prasad
Study ID
NCT00514449
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Valacyclovir — DRUG
    1 g PO BID x 2 weeks after 2 weeks it goes up to 1.5 g PO BID x 16 weeks along with antipsychotic
  • Placebo — DRUG
    2 pills twice a day x 2 weeks, after 2 weeks 3 pills twice a day x 16 weeks along with antipsychotic

Study Details

The purpose of this study is to examine whether antiviral medication will help improve psychotic symptoms and cognition in individuals early in the course of schizophrenia or schizoaffective disorder who are exposed to herpes simplex virus, type 1 (HSV 1), a virus that causes commonly occurring and recurrent cold sores.

Key Dates

Start date
Jun 30, 2007
Status verified
May 2018
Primary completion
Sep 30, 2016
Completion
Sep 30, 2016

Study Design

Enrollment
31 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Valacyclovir
    1 gram pill taken twice a day for 2 weeks, after 2 weeks it increased to 1.5 gram pill taken twice a day for 16 weeks.
  • Placebo Comparator: Sugar pill
    2 placebo pills taken twice a day for 2 weeks, after 2 weeks 3 pills taken twice a day for 16 weeks.

Primary Outcome Measure

PANSS Positive and Negative Syndrome Scale for Schizophrenia [ Time Frame: Baseline, Weeks 2, 4, 6, 10, 14, 18 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Wayne State UniversityDetroitMichigan48201-
Western Psychiatric Institute and ClinicPittsburghPennsylvania15213-

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