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

Part of paid clinical trials in Bellflower, California.

Sponsor
Indiana University
Study ID
NCT02008773
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 26, 2014
Status verified
Jan 2019
Primary completion
Jun 20, 2017
Completion
Jun 20, 2017

Study Design

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

Arms

  • Active Comparator: valacyclovir
    3000mg daily oral 16 weeks
  • Placebo Comparator: placebo
    placebo 6 capsules daily oral 16 weeks

Primary Outcome Measure

Visual Memory [ Time Frame: Baseline, 8 weeks, and 16 weeks ]

Locations (13)

FacilityCityStateZIPSite coordinators
C.I. Trials, Inc.-Los Angeles CountyBellflowerCalifornia90706-
University of California, Los AngelesLos AngelesCalifornia90095-
University of California, Riverside at C.I. Trials, Inc.-Inland EmpireRiversideCalifornia92506-
C.I. Trials, Inc.-Orange CountySanta AnaCalifornia92705-
Yale UniversityNew HavenConnecticut06519-
Innovative Clinical Research, Inc.LauderhillFlorida33319-
Indiana University Psychotic Disorders ClinicIndianapolisIndiana46222-
Prevention and Recovery Center for Early PsychosisIndianapolisIndiana46202-
University of Kansas Medical Center-WitchitaWichitaKansas67214-
Maryland Psychiatric Research CenterBaltimoreMaryland21228-
Centers for Behavioral Health, LLCRockvilleMaryland20850-
Sheppard Pratt Health SystemTowsonMaryland21204-
Laureate Institute for Brain ResearchTulsaOklahoma74136-

Find similar trials in Bellflower, CA

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
C.I. Trials, Inc.-Los Angeles County· Bellflower, CAUniversity of California, Los Angeles· Los Angeles, CAUniversity of California, Riverside at C.I. Trials, Inc.-Inland Empire· Riverside, CAC.I. Trials, Inc.-Orange County· Santa Ana, CAYale University· New Haven, CTInnovative Clinical Research, Inc.· Lauderhill, FL

Related Studies