Phase 2 Completed N=24 Randomized Double-blind Treatment

Systematic Evaluation of Antiviral Medication in Schizophrenia

Schizophrenia · schizoaffective disorder

Source: ClinicalTrials.gov NCT00514449 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2018

Primary outcomePrimary: PANSS Positive and Negative Syndrome Scale for Schizophrenia — 70.08; 83.92; 72.25; 77 Scores on the scale

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.

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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.