Targeting Cognition in Bipolar Disorder With Pramipexole

NCT02397837 | Completed Phase 4 Results DMC

• 3 other identifiers: 2017P0011851R01MH1022571R01MH102309
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Bipolar Disorder

Keywords

Bipolar Disorder; Cognition

Outcome Measures

Primary Outcomes (3)

• MATRICS Consensus Cognitive Battery

  MATRICS Consensus Cognitive Battery (MCCB) as measure of Neurocognitive/Functional Measures is a standardized battery designed to measure cognitive functioning in people with schizophrenia. The MCCB is represented as a composite T score. This T-score scale has a mean of 50 and a standard deviation of 10, where higher scores reflect better performance.

  Baseline

• MATRICS Consensus Cognitive Battery

  MATRICS Consensus Cognitive Battery (MCCB) as measure of Neurocognitive/Functional Measures is a standardized battery designed to measure cognitive functioning in people with schizophrenia. The MCCB is represented as a composite T score. This T-score scale has a mean of 50 and a standard deviation of 10, where higher scores reflect better performance.

  Week 6

• MATRICS Consensus Cognitive Battery

  MATRICS Consensus Cognitive Battery (MCCB) as measure of Neurocognitive/Functional Measures is a standardized battery designed to measure cognitive functioning in people with schizophrenia. The MCCB is represented as a composite T score. This T-score scale has a mean of 50 and a standard deviation of 10, where higher scores reflect better performance.

  Week 12

Secondary Outcomes (7)

• Young Mania Rating Scale (YMRS)

  Baseline and week 12

• Hamilton Rating Scale for Depression (HRSD)

  Baseline and week 12

• Brief Psychiatric Rating Scale (BPRS)

  Baseline and week 12

• Number of Participants With Suicidal Acknowledgements

  up to Week 12

• The Probabilistic Stimulus Selection Task

  Baseline

Study Arms (2)

Pramipexole

EXPERIMENTAL

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.

Drug: Pramipexole

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Pramipexole DRUG

Up to 4.5mg, PO, (by mouth) per day of the 12-week study.

Also known as: Mirapex

Pramipexole

Placebo DRUG

placebo match study drug

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• The Zucker Hillside Hospital: collaborator
• Northwell Health: collaborator
• National Institute of Mental Health (NIMH): collaborator
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (3)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

The Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (2)

• 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.

  PMID: 22152405 BACKGROUND

• 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.

  PMID: 14992985 BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Katherine Burdick
• Organization: Brigham and Women's Hospital

kburdick1@bwh.harvard.edu

617-732-5789

Study Officials

• Katherine Burdick, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Anil Malhotra, MD

  The Zucker Hillside Hospital, North Shore LIJ- Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead Investigator

Study Record Dates

• First Submitted: March 19, 2015
• First Posted: March 25, 2015
• Study Start: October 1, 2014
• Primary Completion: July 26, 2018
• Study Completion: July 26, 2018
• Last Updated: February 28, 2020
• Results First Posted: February 28, 2020

Record last verified: 2020-02

Locations

US (3)