A Randomized Controlled Trial of Cognitive Remediation and D-cycloserine for Individuals With Bipolar Disorder (DCS)
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.
|Bipolar Disorder||Other: CR + DCS (D-cycloserine) Other: CR + placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Trial of Cognitive Remediation and D-cycloserine for Individuals With Bipolar Disorder|
- Change from baseline in cognitive functioning [ Time Frame: 26 weeks ]
Level of cognitive functioning will be assessed via the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery & Cognitive Neuroscience Test Reliability and Clinical Applications for Schizophrenia (CNTRACS) battery.
Per existing recommendations for assessment of cognition in individuals w/bipolar disorder, the MATRICS battery will be supplement with (i) the California Verbal Learning Test; (ii) the Stroop Test; (iii) Trail Making Test-part B; and (iv) Wisconsin Card Sorting Test
- Change from baseline in Manic Symptomatology [ Time Frame: 26 weeks ]Manic symptomatology assesed using the Yung Mania Sclare and the Altman Self-Rating Mania Scale
- Change from baseline in Depressive Symptomatology [ Time Frame: 26 Weeks ]Depressive symptomatology assessed using the Inventory or Depressive Symptomatology (Clinician-Rated), Inventory for Depressive Symptomatology (Self-Rated), and Bipolar Depression Rating Scale
- Change from Baseline in Social Functioning [ Time Frame: 26 Weeks ]Social functioning assessed using the Social Functioning Scale
- Change from Baseline in Performance of Tasks of Everyday Living [ Time Frame: 26 Weeks ]Performances of tasks of everyday living assessed using the Brief University of California, San Diego Performance-Based Skills Assessment and the Specific Level of Functioning Assessment Scale
- Change from baseline in emotional, motor, and sensory functioning [ Time Frame: 26 weeks ]Assessed using the NIH Toolbox
- Change from baseline in health-related quality of life [ Time Frame: 26 weeks ]Health-related quality of life assessed using the RAND 36-Item Health Survey
- Change from baseline in service utilization [ Time Frame: 26 Weeks ]Service utilization assessed using the Service Utilization and Resources Form
- Change from baseline in medication adherence [ Time Frame: 26 Weeks ]Medication adherence assessed using the Medication Adherence Rating Scale
- Change from baseline in quality of life [ Time Frame: 26 Weeks ]Quality of life assessed using the World Health Organization Quality of Life Scale
- Change from baseline in stage of recovery [ Time Frame: 26 weeks ]Stage of recovery assessed using the Stages of Recovery Instrument
- Change from baseline in personality traits [ Time Frame: 26 weeks ]Personality traits assessed using the Ten Item Personality Inventory
- Change from baseline in metacognition [ Time Frame: 26 weeks ]Metacognition assessed using the Metacognitive Awareness Inventory
- Change in instrinsic motivation from baseline [ Time Frame: 26 weeks ]Intrinsic motivation assessed using the Intrinsic Motivation Inventory
- Frequency of side effects during study participation [ Time Frame: 26 Weeks ]Assessed using the Systematic Assessment for Treatment Emergent Events
|Actual Study Start Date:||March 2013|
|Study Completion Date:||April 2017|
|Primary Completion Date:||April 2017 (Final data collection date for primary outcome measure)|
Experimental: CR + DCS
Subjects will receive Cognitive Remediation and active study drug.
Other: CR + DCS (D-cycloserine)
CR + DCS
Other Name: DCS and Cognitive Remediation
Active Comparator: CR + placebo
Cognitive Remediation and placebo
Other: CR + placebo
CR + placebo
Other Name: Cognitive Remediation
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01934972
|United States, Arizona|
|University of Arizona Medical Center South Campus|
|Tucson, Arizona, United States, 85713|
|Principal Investigator:||Nicholas Breitborde, PhD||The University of Arizona|