NCT00691353

Brief Summary

Cross - Sectional study requiring one visit at the investigators office for the data collection.

  • Target Group: Patients that suffer from Bipolar Disorder Type 1.
  • YMRS - HAMILTON and GAF scales are going to be used to assess the clinical outcome. The findings are going to be based on the different scores reported by Specialists (before the patients started to use as a therapy atypical antipsychotics / at the time that the visit actually takes place for the cause of the study.) We predefine the time period that the patient should be using atypical antipsychotics at minimum (2 months).
  • The first 9 consecutive patients that visit the Specialist and meet the entry criteria and signs the ICF will be recruited in the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
540

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2008

Shorter than P25 for all trials

Geographic Reach
1 country

20 active sites

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

April 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2008

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

December 3, 2008

Status Verified

December 1, 2008

Enrollment Period

3 months

First QC Date

June 3, 2008

Last Update Submit

December 2, 2008

Conditions

Bipolar Disorder

Keywords

Bipolar Disorderantipsychoticssocial functioningmood stabilizersBipolar Disorder Type Iatypical antipsychoticsmonotherapycotherapy

Outcome Measures

Primary Outcomes (2)

  • Difference in the scores reported in YMRS and Hamilton - D scales from baseline(start of therapy)

    Assessment of the progress of disease 2 to 4 months after the initiation of the therapy(baseline)

  • Assessment of functioning - Relative score reported in GAF scale

    2 - 4 months after the initiation of the therapy. No baseline comparison

Secondary Outcomes (1)

  • To depict sociodemographic characteristics and comorbidities.

    Reported at the site visit

Eligibility Criteria

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

Target Group:Patients that suffer from Bipolar Disorder Type 1 who are treated with atypical antipsychotics as monotherapy or cotherapy with mood stabilizers

You may qualify if:

  • Patients that are diagnosed with Bipolar Disorder Type 1 according to diagnostic criteria DSM - IV
  • Patients that have started therapy with atypical antipsychotics as monotherapy or cotherapy with mood stabilizers the last three months, but have completed 2 full months of therapy.
  • Patients with anxiety disorder can be recruited in the study unless it is dominant.

You may not qualify if:

  • Patients that use antidepressant medication
  • Patients who were treated with depot antipsychotic in the last quarter before their enrollment in the study.
  • Patients who are addicts of toxic substances.
  • Patients who suffer from other serious diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Research Site

Agrinio, Greece

Location

Research Site

Alexandroupoli, Greece

Location

Research Site

Athens, Greece

Location

Research Site

Crete, Greece

Location

Research Site

Elefsina, Greece

Location

Research Site

Ioannina, Greece

Location

Research Site

Karditsa, Greece

Location

Research Site

Katerini, Greece

Location

Research Site

Kos, Greece

Location

Research Site

Kozani, Greece

Location

Research Site

Lamia, Greece

Location

Research Site

Larissa, Greece

Location

Research Site

Nafplion, Greece

Location

Research Site

Pátrai, Greece

Location

Research Site

Piraeus, Greece

Location

Research Site

Rhodes, Greece

Location

Research Site

Serres, Greece

Location

Research Site

Thebes, Greece

Location

Research Site

Thessalonii, Greece

Location

Research Site

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Bipolar DisorderSocial Adjustment

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersSocial BehaviorBehavior

Study Officials

  • Charalambos Touloumis, MD

    Athens Psychiatric Hospital Greece

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 3, 2008

First Posted

June 5, 2008

Study Start

April 1, 2008

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

December 3, 2008

Record last verified: 2008-12

Locations

GR(20)