Risk Factors for Development of Rapid Cycling in Bipolar... | NCT01992302

Studies
Risk Factors for Development of Rapid Cycling in Bipolar Disorder Patients

NCT01992302

Sponsor

Hospital Clinic of Barcelona

Status

Completed

Last Update Posted

Nov 25, 2013Estimated

Enrollment

289Actual

Phase

Not provided

Conditions

Bipolar Disorder

Interventions

Not provided

Countries

Spain

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

Nov 2013

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

Jun 2004

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Nov 6, 2013

First Submission Date that Met QC Criteria

Nov 18, 2013

First Posted Date

Nov 25, 2013Estimated

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

Nov 18, 2013

Last Update Posted Date

Nov 25, 2013Estimated

Description Module

Brief Summary

In this study we tried to elucidate the factors associated with the development of a rapid cycling course in bipolar disorder patients, in a prospective and longitudinal design, and the role of antidepressants. The identification of risk factors is extremely relevant from the clinical point of view. We hypothesized that rapid cycling bipolar disorder is associated with more chronicity, poor outcome, and more antidepressant prescription.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

289Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rapid Cycling Group		Patients who develop a rapid cycling course during the follow-up period.
Non Rapid Cycling Group		Patients who do not develop a rapid cycling course during the follow-up period.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients who develop rapid cycling		8 years

Secondary Outcomes

Measure	Description	Time Frame
Factors associated with the development of a rapid cycling course in bipolar disorder patients		8 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Bipolar I and II disorder patients according to DSM-IV criteria

Exclusion Criteria:

Major medical comorbidities, voluntary drop-out from study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Bipolar I and II disorder patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Barcelona Bipolar Disorders Program, Hospital Clinic Barcelona		Barcelona	Catalonia	08037	Spain

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