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Valacyclovir Augmentation for Cognitive and Functional Remediation in Schizophrenia

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ClinicalTrials.gov Identifier: NCT01794897
Recruitment Status : Completed
First Posted : February 20, 2013
Last Update Posted : October 26, 2016
Sponsor:
Collaborators:
Dr. Ram Manohar Lohia Hospital
Stanley Medical Research Institute
Information provided by (Responsible Party):
Vishwajit Nimgaonkar, MD PhD, University of Pittsburgh

Brief 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.

Condition or disease Intervention/treatment Phase
Herpes Simplex Schizophrenia Schizoaffective Disorder Drug: Experimental: Valacyclovir treatment Drug: Placebo comparator Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Valacyclovir Augmentation for Cognitive and Functional Remediation in Schizophrenia
Study Start Date : February 2013
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Valacyclovir treatment
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 Valacyclovir (VAV) or placebo (PLA) 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.
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.

Drug: 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.

Placebo Comparator: Placebo
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.
Drug: 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.




Primary Outcome Measures :
  1. Cognition [ Time Frame: Assessed at week 16 ]

    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.



Secondary Outcome Measures :
  1. Clinical Severity [ Time Frame: Assessed at week 16 ]
    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.

  2. Social Function [ Time Frame: Assessed at week 16 ]
    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.

  3. Side Effects [ Time Frame: Assessed at week 16 ]
    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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01794897


Locations
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India
Dr. Ram Manohar Lohia Hospital
Delhi, India
Sponsors and Collaborators
University of Pittsburgh
Dr. Ram Manohar Lohia Hospital
Stanley Medical Research Institute
Investigators
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Principal Investigator: Vishwajit Nimgaonkar, MD, PhD University of Pittsburgh
Principal Investigator: Smita Deshpande, MD Dr. Ram Manohar Lohia Hospital

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Responsible Party: Vishwajit Nimgaonkar, MD PhD, Professor of Psychiatry and Human Genetics, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01794897     History of Changes
Other Study ID Numbers: PRO11120013
First Posted: February 20, 2013    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Herpes Simplex
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Valacyclovir
Antiviral Agents
Anti-Infective Agents