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Valacyclovir Augmentation for Cognitive and Functional Remediation in Schizophrenia

NCT ID: NCT01794897

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-09-30

Brief Summary

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The effects of Valacyclovir (VAV) augmentation or placebo (PLA) as adjuncts to conventional antipsychotic drug treatment will be evaluated among patients with schizophrenia who have been exposed to herpes simplex virus type 1 (HSV-1). Hypothesis: Valacyclovir (VAV) augmentation improves (a) cognitive and (b) overall function among Herpes Simples Virus 1 (HSV-1) exposed early course schizophrenia patients.

Detailed Description

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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.

Conditions

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Herpes Simplex Schizophrenia Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Valacyclovir treatment

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 Type EXPERIMENTAL

Experimental: Valacyclovir treatment

Intervention Type DRUG

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. 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.

Placebo comparator

Intervention Type DRUG

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.

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.

Group Type PLACEBO_COMPARATOR

Placebo comparator

Intervention Type DRUG

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.

Interventions

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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 VAV or placebo 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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Written informed consent.
* Both genders, ages 18-50 years
* Schizophrenia / schizoaffective disorder (DSM IV).
* Stable dose of antipsychotic for \> 1 month, continued throughout the study.
* Score 4 or more on one or more items of the Positive and Negative Syndrome Scale.
* Exposed to HSV-1: serum antibody assays.

Exclusion Criteria

* Substance abuse in the past month/dependence past 6 months.
* History / current medical /neurological illnesses e.g., epilepsy.
* Pregnancy.
* History of immune disorders, HIV infection, or receiving immune-suppressants.
* Receiving regular antiviral therapy.
* History of hypersensitivity to Valacyclovir.
* Mental retardation as defined in DSM IV.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr. Ram Manohar Lohia Hospital

OTHER_GOV

Sponsor Role collaborator

Stanley Medical Research Institute

OTHER

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Vishwajit Nimgaonkar, MD PhD

Professor of Psychiatry and Human Genetics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vishwajit Nimgaonkar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Smita Deshpande, MD

Role: PRINCIPAL_INVESTIGATOR

Dr. Ram Manohar Lohia Hospital

Locations

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Dr. Ram Manohar Lohia Hospital

Delhi, , India

Site Status

Countries

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India

Other Identifiers

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PRO11120013

Identifier Type: -

Identifier Source: org_study_id