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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00741299
Other study ID # GKN2007
Secondary ID GKN2007
Status Completed
Phase N/A
First received August 25, 2008
Last updated July 25, 2012
Start date August 2007
Est. completion date September 2009

Study information

Verified date July 2012
Source Tirat Carmel Mental Health Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.)


Description:

An association exists between smoking and schizophrenia, independent of other factors and related to psychotic symptomatology. Only a few small descriptive studies have examined the prevalence and correlates of tobacco use among bipolar patients with conflicting results. Patients who smoke score higher on rating scales for psychotic symptoms than their non-smoking peers. While the association of smoking with psychotic symptomatology in schizophrenia is established, such association according to bipolar affective disorder has been reported in a few studies and remains unclear. Also a few studies reported about association of smoking with depressive and manic symptoms, and with suicidal behavior in bipolar patients. Thus further investigation of these issues is warranted.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date September 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Unwillingness or inability to participate in the study

Study Design

Time Perspective: Retrospective


Locations

Country Name City State
Israel Tirat Carmel Mental Health Center Tirat HaCarmel

Sponsors (1)

Lead Sponsor Collaborator
Tirat Carmel Mental Health Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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