Phase 4
Completed N=63
Targeting Cognition in Bipolar Disorder With Pramipexole
Source: ClinicalTrials.gov NCT02397837 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: MATRICS Consensus Cognitive Battery — 35.45; 38.07 T-score — p=0.38
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Converging evidence suggests that patients with bipolar disorder suffer from deficits in neurocognitive functioning that persist, despite remission of acute affective symptoms. These impairments contribute directly to functional disability, highlighting the need for interventions above and beyond standard treatments in order to achieve a full inter-episode recovery. The current study aims to investigate the safety and efficacy of a dopamine agonist (pramipexole), on these persistent cognitive abnormalities in euthymic bipolar patients using a placebo-controlled, adjunctive, 12-week trial design.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MATRICS Consensus Cognitive Battery |
36.46; 41.50 | 0.17 |
| SECONDARY Young Mania Rating Scale (YMRS) |
-0.92; -0.57 | 0.55 |
| SECONDARY Hamilton Rating Scale for Depression (HRSD) |
-0.24; -.22 | 0.99 |
| SECONDARY Brief Psychiatric Rating Scale (BPRS) |
-0.63; -0.61 | 0.98 |
| SECONDARY Number of Participants With Suicidal Acknowledgements |
0; 5 | — |
| SECONDARY The Probabilistic Stimulus Selection Task |
59.54; 50.99 | 0.17 |
Eligibility Criteria
Inclusion criteria
- Age 18-65
- DSM-IV BD I or II diagnosis
- Affective stability, defined by a Young Mania Rating Scale (YMRS) rating of 1 month prior to enrollment, with no medication changes planned over the 12-week study period.
Exclusion Criteria
- History of CNS trauma, neurological disorder, ADHD, or learning disability
- Positive urine toxicology or DSM-IV diagnosis of substance abuse/dependence within 3 months
- Active, unstable medical problem that may interfere with cognition
- Recent history of rapid-cycling
- Abnormal lab or ECG result at screen
- History of heart failure
- Significant suicidal risk (HRSD item 3 > 2 or by clinical judgment)
- Estimated IQ in MR range as per Wide Range Achievement Test (WRAT) standard score of less than 70
- Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (including oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy)
- Women who are breastfeeding
- Participation in any other investigational cognitive enhancement study within 30 days
Data sourced from ClinicalTrials.gov (NCT02397837). 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.