Research Study of Bipolar Mood Symptoms and Cognitive Problems

NCT00428298 | Completed Phase 2 Results

• 1 other identifier: 00009034
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a sixteen week, randomized, double-blind add-on study of valacyclovir versus placebo in approximately 60 outpatients meeting diagnostic criteria according to the Diagnostic and Statistical Manual of Mental Disorders (DSM) -IV Bipolar I or II disorder, testing positive for HSV-1 and who have demonstrable cognitive impairment defined as a total score of less than 85 (one standard deviation from the normal range) on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). Each patient will be randomized to double-blind treatment with either valacyclovir or placebo for sixteen weeks. All subjects will be maintained on a stable regimen of psychiatric drugs prescribed by their treating psychiatrist. Patients will be evaluated every 2 weeks by the treatment team and mood rating scales will be administered at each visit including the Young Mania Rating Scale (YMRS) and the Montgomery Asberg Depression Rating Scale (MADRS). The RBANS will be administered again at 8 and 16 weeks. Both the treatment team and the patient will remain blinded during the course of the study. Following the active treatment phase, patients will receive treatment as clinically indicated. Primary Hypothesis: Valacyclovir will be superior to placebo in reducing cognitive symptoms associated with bipolar disorder in subjects who have been previously infected with Herpes Simplex virus I (HSV-1). Secondary Hypothesis: Valacyclovir will be superior to placebo in reducing mood symptoms associated with bipolar disorder in subjects who have been previously infected with HSV-1.

Conditions

Bipolar Disorder

Keywords

Bipolar; Cognitive; Attention; Memory; Manic Depression; Bi-polar

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status at 16 Weeks

  The RBANS is a brief, independently administered measurement of cognitive decline or improvement. The test is comprised of 12 subtests which comprise 5 domains. The age of the participant and the scores from each domain inform the total RBANS score (Index Score) analyzed in this study. The range for total score is 40-160. If the total score for a subject increases this denotes improved performance on the RBANS. The RBANS was administered at baseline and 16 weeks.

  16 weeks

Secondary Outcomes (1)

• Change From Baseline in Montgomery Asberg Depression Score at 16 Weeks

  16 weeks

Other Outcomes (1)

• Change From Baseline in Young Mania Rating Scale (YMRS) at 16 Weeks

  16 weeks

Study Arms (2)

Active Treatment Valacyclovir

EXPERIMENTAL

Subjects dispensed 500 mg capsules. Subjects take two 500 mg capsules twice daily for 16 weeks.

Drug: Valacyclovir

Placebo Treatment

PLACEBO COMPARATOR

Subjects dispensed 500 mg capsules. Subjects take two 500 mg capsules twice daily for 16 weeks.

Drug: Placebo

Interventions

Valacyclovir DRUG

Subjects take two 500 mg capsules twice daily for 16 weeks.

Also known as: Valtrex

Active Treatment Valacyclovir

Placebo DRUG

Subjects take two 500 mg capsules twice daily for 16 weeks.

Placebo Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be between the ages of 18-65
• Have a diagnosis of Bipolar I or II disorder (as defined by DSM-IV)
• Be in active treatment with an outpatient psychiatrist
• Test positive for HSV1
• Demonstrate cognitive impairment on the RBANS as defined by a total score of less than 85 (i.e. greater than one standard deviation below normal).

You may not qualify if:

• Either pregnant or nursing
• Have a history of hypersensitivity or intolerance to valacyclovir or acyclovir
• Meet criteria for DSM-IV substance abuse (except nicotine and caffeine) within the past 90 days
• Had Electroconvulsive Therapy (ECT) within three months prior to randomization
• Judged to be at serious suicidal risk; inability to provide informed consent.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Stanley Medical Research Institute: collaborator

Study Sites (1)

Johns Hopkins University School of Medicine, Dept. of Psychiatry

Baltimore, Maryland, 21207, United States

Location

Related Publications (3)

• Dickerson FB, Boronow JJ, Stallings CR, Origoni AE, Yolken RH. Reduction of symptoms by valacyclovir in cytomegalovirus-seropositive individuals with schizophrenia. Am J Psychiatry. 2003 Dec;160(12):2234-6. doi: 10.1176/appi.ajp.160.12.2234.

  PMID: 14638597 BACKGROUND

• Dickerson FB, Boronow JJ, Stallings C, Origoni AE, Cole S, Krivogorsky B, Yolken RH. Infection with herpes simplex virus type 1 is associated with cognitive deficits in bipolar disorder. Biol Psychiatry. 2004 Mar 15;55(6):588-93. doi: 10.1016/j.biopsych.2003.10.008.

  PMID: 15013827 BACKGROUND

• Dickerson FB, Boronow JJ, Stallings C, Origoni AE, Sullens A, Yolken RH. The catechol O-methyltransferase Val158Met polymorphism is not associated with broad-based cognitive functioning in schizophrenia. Schizophr Res. 2007 Nov;96(1-3):87-92. doi: 10.1016/j.schres.2007.05.021. Epub 2007 Jul 2.

  PMID: 17601704 BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jennifer L. Payne MD
• Organization: Johns Hopkins UNiversity School of Medicine

jpayne5@jhmi.edu

410-502-0050

Study Officials

• Jennifer L Payne, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2007
• First Posted: January 30, 2007
• Study Start: March 1, 2007
• Primary Completion: August 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 11, 2017
• Results First Posted: April 11, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)