NCT01992302

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
289

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

9.4 years

First QC Date

November 6, 2013

Last Update Submit

November 18, 2013

Conditions

Bipolar Disorder

Keywords

Rapid cycling

Outcome Measures

Primary Outcomes (1)

  • Number of patients who develop rapid cycling

    8 years

Secondary Outcomes (1)

  • Factors associated with the development of a rapid cycling course in bipolar disorder patients

    8 years

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Bipolar I and II disorder patients

You may qualify if:

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

You may not qualify if:

  • Major medical comorbidities, voluntary drop-out from study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barcelona Bipolar Disorders Program, Hospital Clinic Barcelona

Barcelona, Catalonia, 08037, Spain

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 6, 2013

First Posted

November 25, 2013

Study Start

June 1, 2004

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

ES(1)