NCT00584961

Brief Summary

To assess the prevalence of Metabolic Syndrome in Spanish population with Bipolar I or II Disorder. To analyse the clinical progress disease in patients with Bipolar I or II Disorder for 12 months using the assessment of the symptoms disease and the progress of metabolic and cardiovascular risk. To analyse the health status, quality of life and functioning/disability of patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
553

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2007

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 2, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

1.8 years

First QC Date

December 21, 2007

Last Update Submit

February 18, 2021

Conditions

Bipolar Disorder

Keywords

Metabolic Syndrome, Bipolar Disorder and Cardiovascular Risk Factors

Outcome Measures

Primary Outcomes (3)

  • Evolution of Modifiable Metabolic and Cardiovascular Risk Factors (Weight, and serum levels of Glucose, Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol and Triglycerides)

    12 months

  • Clinical Evolution of the Disease

    12 months

  • Cardiovascular Risk

    12 months

Secondary Outcomes (4)

  • Current pattern of treatment in Bipolar Disorder

    12 month

  • Prevalence of Metabolic Syndrome in Spanish Population with Bipolar Disorder

    1 day

  • Patient functional impairment

    12 months

  • Patient quality of life

    12 month

Study Arms (1)

600 patients

Patients with diagnosis of Bipolar Disorder (DSM-IV TR)

Other: non-interventional

Interventions

non-interventionalOTHER

non-interventional

600 patients

Eligibility Criteria

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

Community sample. Patients \>17 years older with diagnosis of Bipolar Disorder (DSM-IV TR)

You may qualify if:

  • Patients with diagnosis of Bipolar Disorder (DSM-IV TR)
  • Patients or their legal representatives have provided informed consent

You may not qualify if:

  • Patients are unable to complete or to understand health questionnaires in Spanish language
  • Patients enrolled in clinical trials or other studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Bipolar DisorderMetabolic Syndrome

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 2, 2008

Study Start

May 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

February 21, 2021

Record last verified: 2021-02