A Randomized Controlled Trial of Cognitive Remediation and D-cycloserine for Individuals With Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      Individuals with bipolar disorder suffer from a broad array of cognitive deficits that may
      hinder their ability to achieve successful community functioning. Consequently, greater
      attention has recently been directed toward the development of strategies to ameliorate these
      cognitive deficits. One strategy which has been shown to be successful in this endeavor is
      cognitive remediation (CR). This intervention, which is recognized as a "best practice" in
      the treatment of serious mental illness, is typically comprised of a series of repeated
      exercises delivered by a clinician or via a computer that are designed to improve performance
      in cognitive functioning. Yet, despite the promise of cognitive remediation, the benefit of
      this intervention among individuals with bipolar disorder has yet to be investigated.

      Recently, studies have demonstrated that d-cycloserine (DCS), an N-methyl-D-aspartate
      receptor (NMDAR) agonist, may facilitate the learning process for emotional and non-emotional
      information in both humans and animals. These results raise the possibility that DCS may
      increase the benefits associated with the receipt of cognitive remediation among individuals
      with bipolar disorder. To date, we are unaware of any study which has examined whether
      concurrent receipt of DCS may increase the benefits produced by cognitive remediation among
      individuals with a severe mental illness.

      Thus, we propose to complete an exploratory investigation of augmenting cognitive remediation
      with DCS among individuals with bipolar disorder. Approximately forty subjects will be
      randomized to one of two study arms: [i] CR + DCS; or [ii] CR + placebo. The primary outcome
      of interest will be changes in cognitive functioning before and after receipt of the
      cognitive remediation intervention. Secondary outcomes of interest will be changes in
      symptomatology, social and vocational functioning, and performance of tasks of everyday
      living.
    

Intervention name(s): CR + DCS (D-cycloserine); CR + placebo
Intervention type(s): Other; Other
Intervention description(s): CR + DCS; CR + placebo
Other intervention name(s): DCS and Cognitive Remediation; Cognitive Remediation
Intervention MeSH terms: Cycloserine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar disorder