A Randomized Controlled Trial of Cognitive Remediation and D-cycloserine for Individuals With Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: CR + DCS (D-cycloserine); CR + placebo
Intervention description: CR + DCS; CR + placebo
Intervention MeSH terms: Cycloserine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Bipolar disorder

Summary:

      Individuals with bipolar suffer from problems in basic cognitive skills such as memory and
      concentration. Unfortunately, there are no current treatments that have been shown to improve
      cognitive skills among individuals with bipolar disorder.

      Computerized cognitive remediation (CR) is a treatment that has been shown to improve
      cognitive skills among individuals with serious mental illnesses other than bipolar disorder,
      such as schizophrenia. This treatment involves completing a series of activities on a
      computer that have been shown to improve cognitive skills.

      D-cycloserine (DCS) is an antibiotic traditionally used in the treatment of tuberculosis.
      Recent studies have suggested that this drug may also improve individuals' ability to learn.
      Thus, the goal of our study is to examine whether receipt of d-cycloserine increases the
      benefit that individuals receive from participation in cognitive remediation.

      To test this hypothesis, approximately forty subjects will be randomized to one of two study
      arms: [i] CR + DCS or [ii] CR + placebo. We will examine whether d-cycloserine increases the
      benefit that individuals with bipolar disorder receive from participation in cognitive
      remediation.
    

Eligibility criteria:

        - Inclusion Criteria: [i] Diagnosis of Bipolar I or Bipolar II Disorder determined by the
        Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders
        (DSM) [ii] Ages 18-65 [iii] No evidence of mental retardation, dementia, or other organic
        disorder that may reduce cognitive functioning [iv] premorbid intelligence quotient (IQ)
        greater than or equal to 70 as determined by reading subtest of the Wide Range Achievement
        Test.

        [v] Able to provide informed consent as evidenced by passing the informed consent quiz with
        a score of 80% or greater.

        [vi] Fluent in English as assessed per self-report from participant [vii] Female subjects
        cannot be pregnant or breastfeeding. All subjects must consent to using at least one form
        of birth control during study participation.

        [viii] Current remission of depressive symptoms as indicated by a score of 8 or less on the
        Bipolar Depression Rating Scale.

        [ix] Current remission of manic symptoms as indicated by a score of 7 or less on the Young
        Mania Scale

        Exclusion criteria:

        [i] Hypersensitivity to previous receipt of cycloserine per subject report [ii] Epilespy or
        history of seizures as assessed using the Medical History form [iii] Meets DSM-IV criteria
        for alcohol or drug abuse in the past month or dependence in the past three months.

        [iv] Active suicidal or homicidal ideation [v] Initiation or increase in dosage of any
        antidepressant within six weeks, or mood stabilizer within four weeks as assessed using the
        Medication Checklist.

        [vi] Previous or current participation in cognitive remediation per subject report [vii]
        Currently taking d-cycloserine [viii] Reduced kidney or liver functioning, vitamin B12
        deficiency, folic acid deficiency, megaloblastic anemia, or sideroblastic anemia per
        baseline safety labs.

        [ix] Currently taking medication known to have problematic interactions with d-cycloserine,
        including etionamide and isoniazid.

        [x] History of the blood disease porphyria as assessed using the Medical History form [xi]
        Current active symptoms of psychosis defined as not meeting existing guidelines [12] for
        remission of psychotic symptoms using the Positive and Negative Syndrome Scale.