A Randomized Controlled Trial of Cognitive Remediation and D-cycloserine for Individuals With Bipolar Disorder

Completed · Phase 3 · Has a placebo group

Conditions studied: Bipolar Disorder

In brief

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.

Key facts

Study ID

NCT01934972

Run by

University of Arizona

People needed

30

Starts

2013-03-01

Expected to finish

2017-04-01

Last updated by the study team

2020-06-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• [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.

Where it is running

• University of Arizona Medical Center South Campus — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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