A Double-Blind Trial of Adjunctive Valacyclovir to Improve Cognition in Early Phase Schizophrenia

Summary

The primary aim of the study is to determine the efficacy of adjunctive valacyclovir, in comparison to placebo, to improve visual (Brief Visuospatial Memory Test) and working (composite score of the Spatial Span and Letter Number Span tests) memory in individuals who are HSV-1 positive and early in the course of schizophrenia.

We hypothesize that individuals who are HSV-1 positive, but not those who are HSV-1 negative, will demonstrate significant valacyclovir efficacy for visual and working memory.

Conditions

• Schizophrenia

Interventions

DRUG

Valacyclovir HCI 500 mg tablets

Valacyclovir HCI 500 mg capsules 6/day oral for 16 weeks

DRUG

placebo

placebo capsules 6/day oral for 16 weeks

Sponsors & Collaborators

• Stanley Medical Research Institute

  collaborator OTHER

• Sheppard Pratt Health System

  collaborator OTHER

• University of Maryland

  collaborator OTHER

• Centers for Behavioral Health, LLC

  collaborator UNKNOWN

• Laureate Institute for Brain Research, Inc.

  collaborator OTHER

• University of Kansas Medical Center

  collaborator OTHER

• University of California, Los Angeles

  collaborator OTHER

• Yale University

  collaborator OTHER

• Innovative Clinical Research, Inc.

  collaborator INDUSTRY

• University of California Riverside at C.I. Trials, Inc.-Inland Empire

  collaborator UNKNOWN

• Clinical Innovations

  collaborator INDUSTRY

• Indiana University

  lead OTHER

Principal Investigators

• Alan Breier, MD · Indiana University

• Faith Dickerson, PhD · Shepard Pratt Health System

• Robert Buchanan, MD · University of Maryland

• Robert Litman, MD · Centers for Behavioral Health, LLC

• Sheldon Preskorn, MD · University of Kansas (KUMC)

• Brent Wurfel, MD, PhD · Laureate Institute for Brain Research

• Stephen Marder, MD · University of California, Los Angeles

• Keith Nuechterlein, PhD · University of California, Los Angeles

• Deepak D'Souza, MD · Yale University

• Rishi Kakar, MD · Innovative Clinical Research, Inc.

• Gerald Maguire, MD · University of California, Riverside

• Diane Highum, MD · Clinical Innovations

• Evagelos Coskinas, MD, PhD · Clinical Innovations

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-03-26

Primary Completion

2017-06-20

Completion

2017-06-20

Countries

• United States

Study Locations