Phase 2
N=24
Systematic Evaluation of Antiviral Medication in Schizophrenia
Schizophrenia · Schizoaffective Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00514449 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: PANSS Positive and Negative Syndrome Scale for Schizophrenia — 70.08; 83.92; 72.25; 77 Scores on the scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Valacyclovir (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Konasale Prasad
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PANSS Positive and Negative Syndrome Scale for Schizophrenia |
70.08; 83.92; 72.25; 77; 67.36; 75.2 | — |
| PRIMARY Cognitive Function Neuropsychological Battery (Gur Battery) |
2.13; 0.13; 2.44; -0.49 | — |
| SECONDARY Changes in Grey Matter Deficit |
26.83; 24.22 | 0.004 sig |
Summary
The purpose of this study is to examine whether antiviral medication will help improve psychotic symptoms and cognition in individuals early in the course of schizophrenia or schizoaffective disorder who are exposed to herpes simplex virus, type 1 (HSV 1), a virus that causes commonly occurring and recurrent cold sores.
Eligibility Criteria
Inclusion Criteria
- Both genders between the ages of 18-50 years
- Schizophrenia or schizoaffective disorder as defined in DSM-IV
- Duration of illness 10 years or less
- On a stable dose of an antipsychotic medication for at least a month
- Should score 4 or more on at least one of the subscales of PANSS
- Positive for HSV1
- Written informed consent
Exclusion Criteria
- Substance abuse in the last month/dependence 6 months prior to the study
- History of, or current medical/neurological illnesses which affects CNS function e.g., epilepsy, head injury with prolonged loss of consciousness
- Pregnancy
- History of immune disorders, HIV infection or currently receiving immunosuppressants
- Subjects on regular antiviral therapy
- History of hypersensitivity to Valacyclovir
- Mental retardation as defined in DSM-IV
Data sourced from ClinicalTrials.gov (NCT00514449). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.