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Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study

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University of Pittsburgh

Status and phase

Completed
Phase 4

Conditions

Bipolar Disorder

Treatments

Drug: paroxetine
Drug: lamotrigine
Drug: mirtazapine
Drug: tranylcypromine
Drug: venlafaxine
Drug: bupropion
Drug: risperidone
Drug: olanzapine
Drug: Depakote-ER
Drug: lithium carbonate

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The purpose of this study is to collect pilot data on the feasibility of recruiting, eliciting informed consent, assessing, treating, and following patients aged 60 and older with bipolar mood disorders.

Full description

Study specific aims are:

  • to establish a recruitment, referral, and collaborative network for elderly bipolar patients, in collaboration with the NIMH funded STEP-BD
  • to establish an outpatient treatment clinic at the Bellefield Towers site of the NIMH funded Intervention Research Center for Late Life Mood Disorders
  • to implement standardized care pathways compatible with STEP-BD treatment algorithms for mood stabilizing pharmacotherapy.
  • to document short- and long-term treatment response with respect to affective symptoms, sleep, general life functioning, cognition, treatment-emergent side effects
  • to establish the clinical infrastructure necessary for randomized controlled clinical trials and for clinical research training in bipolar mood disorders of late-life.

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • DSM-IV diagnosis of Bipolar Disorder
  • Folstein Mini-Mental Status Exam score of 18 or higher

Exclusion criteria

  • Medical condition that precludes the use of both lithium and depakote
  • If mood disturbance is deemed an organic mood disorder (i.e., iatrogenic, secondary to medication)
  • If refuse to designate someone who the study staff can contact about bipolar symptoms, concerns about the subject's health, in an emergency, and/or inability to reach the subject.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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