A Randomized Controlled Trial of Cognitive Remediation and D-cycloserine for Individuals With Bipolar Disorder
Source: ClinicalTrials.gov NCT01934972 ↗Summary
Linked Publications
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A randomized controlled trial of cognitive remediation and d-cycloserine for individuals with bipolar disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Cognitive Functioning |
10.90; 7.12 | — |
| SECONDARY Change From Baseline in Manic Symptomatology |
0.27; -0.25 | — |
| SECONDARY Change From Baseline in Depressive Symptomatology |
1.25; 2.67 | — |
| SECONDARY Change From Baseline in Social Functioning |
17.87; 30.85 | — |
| SECONDARY Change From Baseline in Functional Capacity |
9.59; -9.26 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01934972) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.