Phase 4 N=63 Randomized Triple-blind Treatment

Targeting Cognition in Bipolar Disorder With Pramipexole

Bipolar Disorder

Bottom Line

View on ClinicalTrials.gov: NCT02397837 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2020

Primary outcome: Primary: MATRICS Consensus Cognitive Battery — 35.45; 38.07 T-score — p=0.38

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Pramipexole (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Brigham and Women's Hospital
Primary completion: Jul 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY MATRICS Consensus Cognitive Battery	36.46; 41.50	0.17
PRIMARY MATRICS Consensus Cognitive Battery	36.46; 41.50	0.17
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
SECONDARY The Probabilistic Stimulus Selection Task	59.54; 50.99	0.17
SECONDARY The Probabilistic Stimulus Selection Task	59.54; 50.99	0.17

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.

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

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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.