NCT00741299

Brief Summary

The purpose of this study is to examine whether tobacco smoking is associated with bipolar affective disorder (severity of depressive and manic symptoms, presence of psychotic symptoms, history of a suicide attempts and other clinical features.)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2007

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

July 26, 2012

Status Verified

July 1, 2012

Enrollment Period

1.9 years

First QC Date

August 25, 2008

Last Update Submit

July 25, 2012

Conditions

Bipolar Disorder

Keywords

bipolar affective disorder, Smoking

Outcome Measures

Primary Outcomes (1)

  • Relationship between smoking and other factors including: bipolar subtype, current and past clinical status, illness severity,history of a suicide attempts, age of bipolar onset, gender, education, social class, economic status.

    One interview session

Eligibility Criteria

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

The sample will consist of all patients ascertained in database of Tirat Carmel Mental Health Center and Psychiatric Outpatients Clinic, Rambam Medical Center

You may qualify if:

  • Age 18-65 male or female
  • DSM -IV criteria for bipolar I affective disorder
  • Ability and willingness to sign informed consent for participation in the study

You may not qualify if:

  • Unwillingness or inability to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tirat Carmel Mental Health Center

Tirat HaCarmel, Tirat HaCarmel, 30200, Israel

Location

Related Publications (1)

  • Kreinin A, Novitski D, Rabinowitz D, Weizman A, Grinshpoon A. Association between tobacco smoking and bipolar affective disorder: clinical, epidemiological, cross-sectional, retrospective study in outpatients. Compr Psychiatry. 2012 Apr;53(3):269-74. doi: 10.1016/j.comppsych.2011.04.063. Epub 2011 Jun 12.

    PMID: 21664608DERIVED

MeSH Terms

Conditions

Bipolar DisorderSmoking

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersBehavior

Study Officials

  • Anatoly Kreinin, MD, PHD

    B. Rappaport Faculty of Medicine, Technion, Haifa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of psychiatric department

Study Record Dates

First Submitted

August 25, 2008

First Posted

August 26, 2008

Study Start

August 1, 2007

Primary Completion

July 1, 2009

Study Completion

September 1, 2009

Last Updated

July 26, 2012

Record last verified: 2012-07

Locations

IL(1)