Valacyclovir Augmentation for Cognitive and Functional Remediation in Schizophrenia

October 25, 2016 updated by: Vishwajit Nimgaonkar, MD PhD, University of Pittsburgh
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

134

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Delhi, India
        • Dr. Ram Manohar Lohia Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
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 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.
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.
PLACEBO_COMPARATOR: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognition
Time Frame: Assessed at week 16

The following measures will be used to assess cognitive functioning both before and after treatment with Valacyclovir:

Cognition: (1) Trail Making Test (TMT). This paper and pencil test is a convenient estimate of cognitive function, principally focusing on attention, working memory and executive function. (2) Computerized Neuropsychological Battery (CNB). We have validated a Hindi version of the Penn CNB and administered it to over 300 Indian participants. The CNB includes cognitive measures that distinguish SZ cases and relatives from controls. Accuracy and response time are recorded. Cognitive domains assessed: Abstraction and mental flexibility; Attention; Verbal Memory; Face Memory; Spatial Memory; Spatial Processing; Sensory-motor Dexterity; Emotion Processing.
Assessed at week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Severity
Time Frame: Assessed at week 16
Clinical Severity will be measured by the following assessments: (i) Positive and Negative Syndrome Scale (PANSS. The PANSS is 7 point rating scale for 30 psychopathological items based on interviews or reports. (ii) Clinical Global Impression - Severity (CGI-S). The CGI-S is a 7-point scale that rates the severity of the patient's illness at the time of assessment.
Assessed at week 16
Social Function
Time Frame: Assessed at week 16
Social function will be measured by: (1) Independent Living Skills Survey (ILSS), a comprehensive, validated measure of functional living skills including self rated and observer rated portions (2) Sheehan's disability scale (SDS), a self-report tool that assesses functional impairment in work/school, social and family life with a 10-point visual analogue scale; (3) Global Assessment of Function (GAF), a global measure of function and symptom severity (4) Quality of Life Scale (QOL) measures interpersonal, social and occupational functioning.
Assessed at week 16
Side Effects
Time Frame: Assessed at week 16
Side effects will be assessed using: (1) Abnormal Involuntary Movement Scale This scale rates the severity of dyskinetic movements. Orofacial, neck-trunk and distal (limb) movements are rated separately. 2) Barnes Akathisia Scale: A rating scale to assess the severity of drug-induced akathisia.
Assessed at week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

Stanley Medical Research Institute
Dr. Ram Manohar Lohia Hospital

Investigators

  • Principal Investigator: Vishwajit Nimgaonkar, MD, PhD, University of Pittsburgh
  • Principal Investigator: Smita Deshpande, MD, Dr. Ram Manohar Lohia Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

September 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

February 6, 2013

First Submitted That Met QC Criteria

February 15, 2013

First Posted (ESTIMATE)

February 20, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO11120013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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