Completed

Valacyclovir Augmentation for Cognitive and Functional Remediation in Schizophrenia

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Experimental: Valacyclovir treatment

+ Placebo comparator

+ Placebo comparator

Drug
Who is being recruted

Mental Disorders+10

+ DNA Virus Infections

+ Herpesviridae Infections

From 18 to 50 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Placebo-ControlledPhase 4
Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorUniversity of Pittsburgh
Last updated: October 26, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

Design: We propose a randomized double blind placebo controlled study of patients with early course Schizophrenia (SZ) / schizoaffective disorder (SZA) patients exposed to HSV-1, who are receiving antipsychotic drugs. The effects of VAV augmentation or PLA as adjuncts to conventional antipsychotic drug treatment will be evaluated. As outcomes, we will evaluate clinical symptoms, cognitive variables, overall function (including social function) and side effects. The participants will be under the direct care of the Indian investigators during the study. Ratings will be performed blind by research staff. We will pre-screen for HSV-1 exposure. There will be a 2 week placebo run in phase, 16 week augmentation and 4 week follow up to identify post-treatment side effects.

NCT01794897
Principal SponsorUniversity of Pittsburgh
Last updated: October 26, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

134 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersDNA Virus InfectionsHerpesviridae InfectionsInfectionsSkin DiseasesSkin Diseases, InfectiousVirus DiseasesSkin Diseases, ViralSkin and Connective Tissue DiseasesSchizophrenia Spectrum and Other Psychotic DisordersHerpes SimplexPsychotic DisordersSchizophrenia

Criteria

6 inclusion criteria required to participate
Both genders, ages 18-50 years
Exposed to HSV-1: serum antibody assays
Schizophrenia / schizoaffective disorder (DSM IV)
Score 4 or more on one or more items of the Positive and Negative Syndrome Scale
Show More Criteria
7 exclusion criteria prevent from participating
History / current medical /neurological illnesses e.g., epilepsy
History of hypersensitivity to Valacyclovir
History of immune disorders, HIV infection, or receiving immune-suppressants
Mental retardation as defined in DSM IV
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
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.

Group II

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Dr. Ram Manohar Lohia Hospital

Delhi, IndiaOpen Dr. Ram Manohar Lohia Hospital in Google Maps
CompletedOne Study Center