MedTrace Logo

Targeting Cognition in Bipolar Disorder With Pramipexole

NCT02397837 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2020-02-28

Study results available
· View outcomes & findings →

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

Interventions

DRUG

Pramipexole

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

DRUG

Placebo

placebo match study drug

Sponsors & Collaborators

  • The Zucker Hillside Hospital

    collaborator OTHER

  • Northwell Health

    collaborator OTHER

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Icahn School of Medicine at Mount Sinai

    collaborator OTHER

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Katherine Burdick, PhD · Icahn School of Medicine at Mount Sinai

  • Anil Malhotra, MD · The Zucker Hillside Hospital, North Shore LIJ- Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2018-07-26
Completion
2018-07-26

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02397837 on ClinicalTrials.gov