Valacyclovir Augmentation for Cognitive and Functional Remediation in Schizophrenia

Schizophrenia Clinical Trial

Official title:

Valacyclovir Augmentation for Cognitive and Functional Remediation in Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01794897
• Other study ID #: PRO11120013
• Status: Completed
• Phase: Phase 4
• First received: February 6, 2013
• Last updated: October 25, 2016
• Start date: February 2013
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review BoardUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The effects of Valacyclovir (VAV) augmentation or placebo (PLA) as adjuncts to conventional antipsychotic drug treatment will be evaluated among patients with schizophrenia who have been exposed to herpes simplex virus type 1 (HSV-1). Hypothesis: Valacyclovir (VAV) augmentation improves (a) cognitive and (b) overall function among Herpes Simples Virus 1 (HSV-1) exposed early course schizophrenia patients.

Description:

Design: We propose a randomized double blind placebo controlled study of patients with early course Schizophrenia (SZ) / schizoaffective disorder (SZA) patients exposed to HSV-1, who are receiving antipsychotic drugs. The effects of VAV augmentation or PLA as adjuncts to conventional antipsychotic drug treatment will be evaluated. As outcomes, we will evaluate clinical symptoms, cognitive variables, overall function (including social function) and side effects. The participants will be under the direct care of the Indian investigators during the study. Ratings will be performed blind by research staff. We will pre-screen for HSV-1 exposure. There will be a 2 week placebo run in phase, 16 week augmentation and 4 week follow up to identify post-treatment side effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Written informed consent.

• Both genders, ages 18-50 years

• Schizophrenia / schizoaffective disorder (DSM IV).

• 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:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Herpes Simplex
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• Experimental: Valacyclovir treatment
Patients will have a placebo run-in for two weeks after which they will be evaluated for the variables of interest and then randomized to either VAV or placebo group in a 1:1 proportion. The VAV group will receive 1.5 g Valacyclovir by mouth, twice daily for 16 weeks, after which they will be followed up without VAV for 4 weeks to monitor delayed adverse effects.
• Placebo comparator
Patients will have a placebo run-in for two weeks after which they will be evaluated for the variables of interest and then randomized to either VAV or placebo group in a 1:1 proportion. Subjects in the placebo arm will receive placebo for 16 weeks, after which they will be followed up without placebo for 4 weeks to monitor delayed adverse effects.

Locations

Country	Name	City	State
India	Dr. Ram Manohar Lohia Hospital	Delhi

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	Dr. Ram Manohar Lohia Hospital, Stanley Medical Research Institute

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognition	The following measures will be used to assess cognitive functioning both before and after treatment with Valacyclovir: Cognition: (1) Trail Making Test (TMT). This paper and pencil test is a convenient estimate of cognitive function, principally focusing on attention, working memory and executive function. (2) Computerized Neuropsychological Battery (CNB). We have validated a Hindi version of the Penn CNB and administered it to over 300 Indian participants. The CNB includes cognitive measures that distinguish SZ cases and relatives from controls. Accuracy and response time are recorded. Cognitive domains assessed: Abstraction and mental flexibility; Attention; Verbal Memory; Face Memory; Spatial Memory; Spatial Processing; Sensory-motor Dexterity; Emotion Processing.	Assessed at week 16	No
Secondary	Clinical Severity	Clinical Severity will be measured by the following assessments: (i) Positive and Negative Syndrome Scale (PANSS. The PANSS is 7 point rating scale for 30 psychopathological items based on interviews or reports. (ii) Clinical Global Impression - Severity (CGI-S). The CGI-S is a 7-point scale that rates the severity of the patient's illness at the time of assessment.	Assessed at week 16	No
Secondary	Social Function	Social function will be measured by: (1) Independent Living Skills Survey (ILSS), a comprehensive, validated measure of functional living skills including self rated and observer rated portions (2) Sheehan's disability scale (SDS), a self-report tool that assesses functional impairment in work/school, social and family life with a 10-point visual analogue scale; (3) Global Assessment of Function (GAF), a global measure of function and symptom severity (4) Quality of Life Scale (QOL) measures interpersonal, social and occupational functioning.	Assessed at week 16	No
Secondary	Side Effects	Side effects will be assessed using: (1) Abnormal Involuntary Movement Scale This scale rates the severity of dyskinetic movements. Orofacial, neck-trunk and distal (limb) movements are rated separately. 2) Barnes Akathisia Scale: A rating scale to assess the severity of drug-induced akathisia.	Assessed at week 16	Yes