This trial is active, not recruiting.

Conditions schizophrenia, schizoaffective disorder
Treatments valacyclovir + antipsychotic, placebo + antipsychotic
Phase phase 2
Sponsor University of Pittsburgh
Collaborator Stanley Medical Research Institute
Start date June 2007
End date January 2010
Trial size 150 participants
Trial identifier NCT00514449, 0602032


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
(Active Comparator)
valacyclovir + antipsychotic
1 g PO BID x 4 weeks after 4 weeks it goes up to 1.5 g PO BID x 12 weeks
(Placebo Comparator)
placebo + antipsychotic
2 pills twice a day x 4 weeks, after 4 weeks 3 pills twice a day x 12 weeks

Primary Outcomes

PANSS Positive and Negative Syndrome Scale for schizophrenia
time frame: Baseline, Weeks 2, 4, 6, 10, 14, 18
Cognitive Function Neuropsychological Battery (Gur Battery)
time frame: Baseline, Week 18

Secondary Outcomes

Structural MRI (changes in grey matter deficits), fMRI (brain oxygenation level dependent, BOLD, responses)
time frame: Baseline, Week 18

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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

Additional Information

Official title A Randomized Double-blind Controlled Trial of Valacyclovir Add-on Treatment of HSV Positive Early Course Schizophrenia Patients
Principal investigator Konasale Prasad, MD
Description The main objective of the study is to evaluate the efficacy of add-on treatment of Valacyclovir (VAV), an antiviral medication, in the treatment of early course schizophrenia/schizoaffective disorder patients. Our main hypothesis is that the VAV add-on treatment will improve positive, negative and cognitive symptoms in herpes simplex virus (HSV) positive schizophrenia or schizoaffective disorder patients. We hypothesize that the grey matter reductions in specific brain regions (such as prefrontal regions) will improve in patients on VAV + antipsychotic compared to those on placebo + antipsychotic and the improvements in positive, negative and cognitive symptoms will be correlated with the grey matter changes.
Trial information was received from ClinicalTrials.gov and was last updated in February 2011.
Information provided to ClinicalTrials.gov by University of Pittsburgh.