Phase 4
Completed N=50
Cognitive Enhancement in Bipolar Disorder
Source: ClinicalTrials.gov NCT00597896 ↗Enrolled (actual)
50
Serious AEs
6.7%
Results posted
Jun 2015
Primary outcomePrimary: Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Forward) — 8.43; 8.54; 8.48; 8.13 number of correct numbers recalled
Summary
The purpose of this study is to examine whether the medication pramipexole (Mirapex) may be able to improve cognitive problems (i.e. difficulties with thinking, memory, and concentration) that may be associated with bipolar disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Forward) |
8.43; 8.54; 8.48; 8.13; .05; -.41 | — |
| PRIMARY Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Backward) |
6.48; 6.46; 6.86; 6.67; .38; .21 | — |
| PRIMARY Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Symbol Coding Test |
8.52; 8.08; 9.05; 8.75; .52; .67 | — |
| PRIMARY Change From Baseline to Week 8 in Stroop Color-Word Test |
99.95; 95.42; 103.10; 94.33; 3.14; -1.08 | — |
| PRIMARY Change From Baseline to Week 8 in Trail Making Test Part A |
32.88; 35.37; 28.57; 32.79; -4.31; -2.58 | — |
| PRIMARY Change From Baseline to Week 8 in Trail Making Test Part B |
76.90; 106.14; 75.55; 93.39; -1.35; -12.74 | — |
| PRIMARY Change From Baseline to Week 8 in d2 Test of Attention |
.90; 1.54 | — |
| PRIMARY Change From Baseline to Week 8 in Hopkins Verbal Learning Test |
8.00; 8.13; 8.09; 8.42; .09; .29 | — |
| PRIMARY Change From Baseline to Week 8 in Controlled Oral Word Association Test (COWAT) Letter Fluency |
38.33; 33.63; 39.62; 33.50; 1.29; -.13 | — |
| SECONDARY Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint |
-.9; -1.5 | — |
| SECONDARY Double-blind: Change From Baseline in Clinician-Administered Rating Scale for Mania (CARS-M)Total Score at Endpoint |
.5; -.9 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects between 18 and 65 years of age, who meet Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for BPD I or II (by SCID) and confirmed in the diagnostic consensus conference will be included.
- Subjects must also meet criteria for euthymia described above.
- All subjects must be taking a standard mood stabilizer at a stable therapeutic dose (i.e. lithium, carbamazepine, valproate, lamotrigine).
Exclusion Criteria
- Subjects with a history of central nervous system (CNS) trauma, neurological disorder, Attention Deficit Hyperactivity Disorder (ADHD), or learning disability will be excluded.
- Subjects with a DSM-IV diagnosis of current or recent substance abuse or dependence (in the previous 1 month) will be excluded.
- Moreover, subjects with rapid-cycling during the past year will be excluded (based on SCID).
- Any subject with an active, unstable medical problem that may interfere with cognition will be excluded based on the investigator's judgment.
- While medication status is an important consideration in any study of bipolar disorder, the exclusion of patients taking any medication is not practical, given the high prevalence of combination pharmacotherapy for bipolar disorder. To help control for medication effects on cognition, we plan to limit the types of medications allowed by excluding certain medications with a known impact on cognitive performance.
- Subjects taking clozapine will be excluded due to it's potential overlapping mechanisms of action with pramipexole.
- Subjects taking prescription or over-the counter medications may also be excluded if these medications have been shown to impact cognition (i.e. diphenhydramine).
- The use of benzodiazepines, sedatives, or sleeping pills, within 6 hours of neurocognitive testing will not be allowed. In addition, patients taking topiramate, tricyclic antidepressants, or anticholinergic medications that are known to impact cognition will be excluded from participation.
- Subjects taking any medications that are known to interact with pramipexole (i.e. Zantac, Tagamet, Reglan, Benemid, Probalan, Compazine, Phenergan, quinidine, selegiline, verapamil, and any other medication with a known interaction) will also be excluded.
Data sourced from ClinicalTrials.gov (NCT00597896). 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.