Systematic Evaluation of Antiviral Medication in Schizophrenia (SEAMS)

Konasale Prasad

Status and phase: Completed; Phase 2

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Drug: Valacyclovir; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00514449

0602032

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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31 participants in 2 patient groups, including a placebo group

Valacyclovir

Experimental group

Description:

1 gram pill taken twice a day for 2 weeks, after 2 weeks it increased to 1.5 gram pill taken twice a day for 16 weeks.

Treatment:

Drug: Valacyclovir

Sugar pill

Placebo Comparator group

Description:

2 placebo pills taken twice a day for 2 weeks, after 2 weeks 3 pills taken twice a day for 16 weeks.

Treatment:

Drug: Placebo