Clinical trial NCT01794897: Valacyclovir Augmentation for Cognitive and Functional Remediation in Schizophrenia
Official title: Valacyclovir Augmentation for Cognitive and Functional Remediation in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Herpes Simplex
Schizophrenia
Schizoaffective Disorder
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Dr. Ram Manohar Lohia Hospital
name: Stanley Medical Research Institute
First posted: 2013-02-20
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cognition
timeFrame: Assessed at week 16
Secondary outcomes:
measure: Clinical Severity
timeFrame: Assessed at week 16
measure: Social Function
timeFrame: Assessed at week 16
measure: Side Effects
timeFrame: Assessed at week 16
Other outcomes:
Locations:
city: Delhi
country: India
facility: Dr. Ram Manohar Lohia Hospital
Study officials:
affiliation: University of Pittsburgh
name: Vishwajit Nimgaonkar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dr. Ram Manohar Lohia Hospital
name: Smita Deshpande, MD
role: PRINCIPAL_INVESTIGATOR
References: