A Preliminary Study of the Effectiveness and Tolerability... | NCT00363337

Studies
A Preliminary Study of the Effectiveness and Tolerability of Aripiprazole in Bipolar Depression

NCT00363337

Sponsor

Lindner Center of HOPE

Status

Completed

Last Update Posted

Jun 22, 2011Estimated

Enrollment

31Actual

Phase

Phase 4

Conditions

Bipolar Depression

Interventions

aripiprazole

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

Jun 2011

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

Aug 2006

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Aug 11, 2006

First Submission Date that Met QC Criteria

Aug 11, 2006

First Posted Date

Aug 15, 2006Estimated

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

Jun 21, 2011

Last Update Posted Date

Jun 22, 2011Estimated

Name	Class
University of Cincinnati	OTHER

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

31Actual

Name	Type	Description	Arm Group Labels	Other Names
aripiprazole	Drug	open label treatment with aripiprazole		Abilify

Measure	Description	Time Frame
Montgomery-Asberg Depression Rating Scale (MADRS)		per protocol

Measure	Description	Time Frame
Clinical Global Impression Scale Modified for Bipolar Illness (CGI-BP)		per protocol

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

subjects must have bipolar I, II or NOS disorder as defined by DSM-IV-TR; must have clinical significant depressive symptoms and have failed one or more mood stabilizer trials; may or may not be receiving antimanic or mood stabilizing medications; subjects or legally authorized representative must sign the Informed Consent document after the nature of the trial has been fully explained; if female, subjects must be postmenopausal, surgically incapable of childbearing or practicing medically acceptable effective method(s) of contraception.

Exclusion Criteria:

subjects who do not have bipolar disorder by DSM-IV criteria; subjects with current DSM-IV Axis I diagnosis of delirium, dementia, amnesia or other cognitive disorders or a psychotic disorder; subjects with serious general medical illness; subjects who are allergic to or have demonstrated hypersensitivity to aripiprazole; women who are pregnant or nursing; subjects who have received an experimental drug or used an experimental device within 30 days; subjects who have a history of neurologic malignant syndrome.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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
Susan L McElroy, MD	University of Cincinnati	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Cincinnati Medical Center		Cincinnati	Ohio	45267-0559	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17229469	Result	McElroy SL, Suppes T, Frye MA, Altshuler LL, Stanford K, Martens B, Leverich GS, Post RM, Keck PE Jr. Open-label aripiprazole in the treatment of acute bipolar depression: a prospective pilot trial. J Affect Disord. 2007 Aug;101(1-3):275-81. doi: 10.1016/j.jad.2006.11.025. Epub 2007 Jan 16.

ID	Term
D001714	Bipolar Disorder
D003863	Depression

ID	Term
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms

ID	Term
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D015363	Quinolones