Ropinirole in the Treatment of Bipolar Depression | NCT00314821

Studies
Ropinirole in the Treatment of Bipolar Depression

NCT00314821

Sponsor

Cambridge Health Alliance

Status

Completed

Last Update Posted

Apr 18, 2017Actual

Enrollment

40Estimated

Phase

Phase 4

Conditions

Bipolar Disorder

Interventions

ropinirole

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

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Sep 2005Actual

Primary Completion Date

Jun 1, 2007Actual

Completion Date

Mar 17, 2008Actual

First Submitted Date

Apr 13, 2006

First Submission Date that Met QC Criteria

Apr 13, 2006

First Posted Date

Apr 17, 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

Apr 17, 2017

Last Update Posted Date

Apr 18, 2017Actual

Name	Class
Emory University	OTHER
GlaxoSmithKline	INDUSTRY

Description Module

Brief Summary

To demonstrate efficacy and safety of Requip in in treating bipolar depression.

Detailed Description

This study is 8 weeks long, with an optional additional 8 weeks. The study is placebo-controlled and patients are randomized to receive either ropinerol or placebo. Changes in depression, anxiety and overall psychiatric symptoms will be monitored during participation.

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

40Estimated

Name	Type	Description	Arm Group Labels	Other Names
ropinirole	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary outcome will be group differences between Requip and placebo in random effects linear regression analysis.

Secondary Outcomes

Measure	Description	Time Frame
The secondary outcomes will include predictors of response, such as insight into illness, comorbid anxiety symptoms, prior course of illness, previous treatment history with antidepressants, and other relevant clinical and demographic features.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Meet DSM-IV criteria for bipolar disorder
Current MADRS score > 16
Current MRS-SADS score < 10
Prior to participation in this study, each subject must sign an informed consent.
All patients will be required to also take at least one other mood-stabilizing agent, defined as a standard agent (lithium, valproate, carbamazepine) or a novel anticonvulsant agent (oxcarbazepine, gabapentin, topiramate). If patients are not taking any of these agents on study initiation, they will be required to start one of these agents at study initiation. Study inclusion criteria must be met after at least 2 weeks of treatment with one of these mood-stabilizing agents.

Exclusion Criteria:

Any serious acute medical illness
Any clinically serious evidence of suicidality or score of 3 or greater on suicide item on MADRS scale

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert T Dunn, MD,PhD	Cambridge Health Alliance	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emory University		Atlanta	Georgia	30322	United States
Cambridge Health Alliance

Condition Browse Module

MeSH Terms

ID	Term
D001714	Bipolar Disorder
D003863	Depression

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C046649	ropinirole

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided