Status:

COMPLETED

Functional Remediation for Bipolar Disorder

Lead Sponsor:

University of Michigan

Conditions:

Bipolar Disorder

Eligibility:

All Genders

18-55 years

Phase:

NA

Brief Summary

Bipolar Disorder is a major mood disorder with periodic mood episodes that may be very distressing, both to the individual and to others. When ill, the person is at particular risk for disruptions to ...

Eligibility Criteria

Inclusion

  • diagnosis of bipolar I or II disorder (BD), as determined by a structured diagnostic interview
  • at least three months of clinical remission (euthymia or minimal symptoms), based on the phone screen assessing mood episodes in the prior three months
  • score greater than 11 on a measure of everyday functioning (FAST; described in measures section) indicating at least mild impairment
  • use of a standard bipolar mood-stabilizing medication at the same, adequate dose (according to CANMAT treatment guidelines) for at least 3 months prior to screening, with ability to continue that dose during the study.

Exclusion

  • history of neurological illness or injury (e.g., stroke, brain tumor)
  • documented intellectual disability
  • inability to provide written informed consent
  • substance dependence within last 3 months or substance abuse in last 30 days
  • inability to complete the six-month intervention
  • received ECT in the past 12 months

Key Trial Info

Start Date :

November 17 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 20 2018

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT03403179

Start Date

November 17 2017

End Date

December 20 2018

Last Update

February 28 2019

Active Locations (1)

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1

University of Michigan Depression Center

Ann Arbor, Michigan, United States, 48109