CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 170 enrolled
Drug / intervention
Valacyclovir HCI 500 mg tablets +1 moredrug
Likely dose
Valacyclovir HCI 500 mg tabletsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02008773
NCT02008773Phase 2Completed
CompareCT.gov

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

Indiana University·interventional·Posted Dec 11, 2013·Updated Jan 30, 2019

In Brief

A Phase 2 clinical trial evaluating Valacyclovir HCI 500 mg tablets and placebo for Schizophrenia. Completed, enrolled 170 participants across 13 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
CollaboratorsStanley Medical Research Institute, Sheppard Pratt Health System, University of Maryland, Centers for Behavioral Health, LLC, Laureate Institute for Brain Research, Inc., University of Kansas Medical Center, University of California, Los Angeles, Yale University, Innovative Clinical Research, Inc., University of California Riverside at C.I. Trials, Inc.-Inland Empire, Clinical Innovations

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 11, 2013
Enrollment StartMar 26, 2014
Primary CompletionJun 20, 2017
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 12.6 years ago

Interventions

Valacyclovir HCI 500 mg tabletsdrug

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

placebodrug

placebo capsules 6/day oral for 16 weeks