Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study | NCT00177567

Studies
Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study

NCT00177567

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

Sep 15, 2005Estimated

Enrollment

Phase

Phase 4

Conditions

Bipolar Disorder

Interventions

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

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2001

Primary Completion Date

Not provided

Completion Date

Jan 2004

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2005

Last Update Posted Date

Sep 15, 2005Estimated

Description Module

Brief Summary

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lithium carbonate	Drug
Depakote-ER	Drug
risperidone	Drug
olanzapine	Drug
paroxetine	Drug
bupropion	Drug
lamotrigine	Drug
venlafaxine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The percent of subjects remitting from their index affective episode, the time to remission, the percent of partially and non-remitting patients, the incidence of relapse during continuation treatment, and of recurrence during maintenance treatment

Secondary Outcomes

Measure	Description	Time Frame
Measures of affective symptoms, functional status, side effects, and cognition tracked over acute, continuation, and maintenance phases of treatment.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charles F Reynolds III, MD	University of Pittsburgh	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pittsburgh Medical Center		Pittsburgh	Pennsylvania	15213	United States
University of Pittsubrgh Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D001714	Bipolar Disorder

Ancestor Terms

ID	Term
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016651	Lithium Carbonate
D014635	Valproic Acid
D018967	Risperidone
D000077152	Olanzapine
D017374	Paroxetine
D016642	Bupropion
D000077213	Lamotrigine
D000069470	Venlafaxine Hydrochloride
D014191	Tranylcypromine
D000078785	Mirtazapine

Ancestor Terms

ID	Term
D002254	Carbonates
D000468	Alkalies
D007287	Inorganic Chemicals
D002255	Carbonic Acid

Browse Leaves

Not provided

Browse Branches

Not provided