Targeting Cognition in Bipolar Disorder With Pramipexole
NCT ID: NCT02397837
Last Updated: 2020-02-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
103 participants
INTERVENTIONAL
2014-10-31
2018-07-26
Brief Summary
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Detailed Description
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Randomization will be conducted via a computer generated program and all study staff will be blinded unless un-blinding is required for safety reasons. Subjects will be randomized on a 1:1 ratio with stratification for concomitant antipsychotic status and depression at baseline (HRSD \<8 vs \> 8). Study drug will be blinded and matched to placebo. Adapting from our previous work in BD and according to package labeling, the dosage titration schedule will be slow and flexible. Dosing will be initiated at 0.25 mg QHS on night one, followed by 0.25 mg BID day two onward, and increased every week to a target of 4.5 mg/day. As compared with our previous maximum 1.5 mg/day (Burdick et al. 2012), we opted to allow up to 4.5 mg/day (the maximum approved dosage in Parkinson's disease) to ensure adequate target engagement. We are familiar with this dose range, as 4.5 mg/day was allowed in our study in BD depression (Goldberg et al. 2004). Dosing will be flexible based on side effects; however, if 1.5 mg/day cannot be tolerated, the subject will be discontinued. Titration will occur up to week 6 and then efforts will be made to maintain the same dose until the completion of the trial (week 12).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Pramipexole
Pramipexole, by mouth. Dosing will be initiated at 0.25 mg on night one, followed by 0.25 mg twice-a-day day two onward, and increased every week to a target of 4.5 mg/day for the 12-week duration of the study.
Pramipexole
Up to 4.5mg, PO, (by mouth) per day of the 12-week study.
Placebo
Placebo, by mouth. Dosing will be initiated at 0.25 mg on night one, followed by 0.25 mg twice-a-day day two onward, and increased every week to a target of 4.5 mg/day for the 12-week duration of the study.
Placebo
placebo match study drug
Interventions
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Pramipexole
Up to 4.5mg, PO, (by mouth) per day of the 12-week study.
Placebo
placebo match study drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* DSM-IV BD I or II diagnosis
* Affective stability, defined by a Young Mania Rating Scale (YMRS) rating of \< 8 and a Hamilton Depression Rating Scale (HRSD) rating of \< 16 at screening and baseline. We will further require that any subsyndromal depression has not significantly worsened in the 4 weeks prior to randomization so as to avoid enrolling subjects who are on the verge of a full depressive episode.
* Evidence of clinically-significant neurocognitive impairment at screening
* Clinically-acceptable, stably-dosed, mood stabilizing medication regimen for \> 1 month prior to enrollment, with no medication changes planned over the 12-week study period.
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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The Zucker Hillside Hospital
OTHER
Northwell Health
OTHER
National Institute of Mental Health (NIMH)
NIH
Icahn School of Medicine at Mount Sinai
OTHER
Brigham and Women's Hospital
OTHER
Responsible Party
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Katherine Burdick
Lead Investigator
Principal Investigators
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Katherine Burdick, PhD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Anil Malhotra, MD
Role: PRINCIPAL_INVESTIGATOR
The Zucker Hillside Hospital, North Shore LIJ- Health System
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
The Zucker Hillside Hospital
Glen Oaks, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Countries
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References
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Burdick KE, Braga RJ, Nnadi CU, Shaya Y, Stearns WH, Malhotra AK. Placebo-controlled adjunctive trial of pramipexole in patients with bipolar disorder: targeting cognitive dysfunction. J Clin Psychiatry. 2012 Jan;73(1):103-12. doi: 10.4088/JCP.11m07299. Epub 2011 Nov 29.
Goldberg JF, Burdick KE, Endick CJ. Preliminary randomized, double-blind, placebo-controlled trial of pramipexole added to mood stabilizers for treatment-resistant bipolar depression. Am J Psychiatry. 2004 Mar;161(3):564-6. doi: 10.1176/appi.ajp.161.3.564.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan: Zucker Hillside Hospital Site
Document Type: Study Protocol and Statistical Analysis Plan: Brigham and Women's Hospital Site
Document Type: Informed Consent Form
Document Type: Study Protocol and Statistical Analysis Plan: Mount Sinai School of Medicine Site
Other Identifiers
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