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Effect of Valacyclovir on cognition and functions in schizophrenia

Valacyclovir augmentation for cognitive and functional remediation in schizophrenia: replication and extension - SMRI Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/10/004078
Enrollment
68
Registered
2013-10-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Schizophrenia Health Condition 2: F20- Schizophrenia

Interventions

Intervention1: Valacyclovir : Patients randomized to VAV arm will receive 1.5 g by mouth, twice daily. This dose is identical to the SMRI/PITT trial
it is adequate for suppressive HSV-1 therapy (http://www.drugs.com/pro/valacyclovir.html). Subjects will receive either VAV or placebo for 16 weeks, after which both groups will be followed up withou

Sponsors

The Stanley Medical Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Written informed consent. • Both genders, ages 18-50 years • Schizophrenia / schizoaffective disorder (DSM IV). • Duration of psychosis • 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

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.

Design outcomes

Primary

MeasureTime frame
To Improve cognitive function among HSV-1 exposed Early Course Schizophrenia patients.Timepoint: Baseline, zero week, 2 week, 4 week, 8 week, 12 week, 16 week, 20 week

Secondary

MeasureTime frame
Overall daily functions among HSV-1 exposed Early course schizophreniaTimepoint: Baseline, zero week, 2 week, 4 week, 8 week, 12 week, 16 week, 20 week

Countries

India

Contacts

Public ContactProf Smita N Deshpande

PGIMER-Dr.R.M.L.Hospital

indusszgenes@gmail.com011-23404363

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026