A randomized controlled trial of cognitive remediation and d-cycloserine for individuals with bipolar disorder

Nicholas Jk Breitborde, Spencer C Dawson, Cindy Woolverton, David Dawley, Emily K Bell, Kaila Norman, Angelina Polsinelli, Beth Bernstein, Pamela Mirsky, Christine Pletkova, Felix Grucci 3rd, Carly Montoya, Bernard Nanadiego, Ehsan Sarabi, Michael DePalma, Francisco Moreno, Nicholas Jk Breitborde, Spencer C Dawson, Cindy Woolverton, David Dawley, Emily K Bell, Kaila Norman, Angelina Polsinelli, Beth Bernstein, Pamela Mirsky, Christine Pletkova, Felix Grucci 3rd, Carly Montoya, Bernard Nanadiego, Ehsan Sarabi, Michael DePalma, Francisco Moreno

Abstract

Background: Cognitive remediation (CR) has shown significant promise in addressing the cognitive deficits that accompany serious mental illness. However, this intervention does not appear to completely ameliorate the cognitive deficits that accompany these illnesses. D-cycloserine (DCS), an NMDA receptor partial agonist, has been shown to enhance the therapeutic benefits of learning-based psychosocial interventions for psychiatric disorders. Thus, the goal of this study is to examine the utility of combining cognitive remediation and d-cycloserine in the treatment of cognitive deficits among individuals with bipolar disorder.

Methods/design: Approximately forty individuals with bipolar disorder will be recruited to participate in this study. Participants will be randomized to one of two study arms: CR + DCS or CR + placebo. The primary outcome for this study is change in cognitive functioning. We will also examine several secondary outcomes, including the rate of change of cognitive functioning, social functioning, and symptomatology.

Discussion: Cognitive deficits are a rate-limiting factor in functional recovery among individuals with bipolar disorder. Unfortunately, treatment options for these deficits are limited. The results of the proposed study may reveal a valuable intervention strategy (i.e., CR with concurrent DCS) to improve cognitive functioning among individuals with bipolar disorder. Ultimately, this treatment strategy may prove useful in addressing the cognitive deficits that are ubiquitous across serious mental illnesses.

Trial registration: ClinicalTrials.gov NCT01934972.

Figures

Figure 1
Figure 1
Participant flow and study design.

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