Valacyclovir Augmentation for Cognitive and Functional Remediation in Schizophrenia

NCT01794897 | Completed Phase 4 DMC

• 1 other identifier: PRO11120013
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Herpes Simplex; Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

• Cognition

  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 Outcomes (3)

• Clinical Severity

  Assessed at week 16

• Social Function

  Assessed at week 16

• Side Effects

  Assessed at week 16

Study Arms (2)

Valacyclovir treatment

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.

Drug: Experimental: Valacyclovir treatment; Drug: Placebo comparator

Placebo

PLACEBO COMPARATOR

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

Interventions

Experimental: Valacyclovir treatment 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.

Valacyclovir treatment

Placebo comparator 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; Valacyclovir treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Dr. Ram Manohar Lohia Hospital: collaborator
• Stanley Medical Research Institute: collaborator

Study Sites (1)

Dr. Ram Manohar Lohia Hospital

Delhi, India

Location

MeSH Terms

Conditions

Herpes Simplex; Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Vishwajit Nimgaonkar, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Smita Deshpande, MD

  Dr. Ram Manohar Lohia Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Human Genetics

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: February 20, 2013
• Study Start: February 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 26, 2016

Record last verified: 2016-10

Locations

IN (1)