Bipolar DisorderNCT00741299
A Study of the Association Between Tobacco Smoking and Bipolar Affective Disorder
An observational study of Bipolar Disorder, run by Tirat Carmel Mental Health Center at 1 site in Israel.
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.) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2007to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Unwillingness or inability to participate in the study
Trial locations and contacts
1 site in 1 country.
Israel1 site
Tirat Carmel Mental Health Center
Tirat HaCarmel, Tirat HaCarmel, 30200
About this study
Official title: Association Between Tobacco Smoking and Bipolar Affective Disorder.Clinico-epidemiological, Cross-sectional, Retrospective Study.
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.)
Read the detailed 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.
- Conditions
- Bipolar Disorder
- Keywords
- bipolar affective disorder, Smoking
- Medical subject headings
- Bipolar Disorder, Smoking
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One interview session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2008 (estimated)
- Study startAug 2007
- Primary completionJul 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tirat Carmel Mental Health Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Anatoly Dr. Kreinin, Tirat Carmel Mental Health Center
- Investigators
- Anatoly Kreinin, MD, PHD, Principal investigator, B. Rappaport Faculty of Medicine, Technion, Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00741299
- Sponsor's protocol ID
- GKN2007
- Other IDs
- GKN2007
- Status last verified
- Jul 2012
- First submitted
- 25 Aug 2008
- Last updated
- 26 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21664608
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Tobacco Smoking and Bipolar Affective Disorder.Clinico-epidemiological, Cross-sectional, Retrospective Study.
- ClinicalTrials.gov ID
- NCT00741299
- Acronym / sponsor ID
- GKN2007
- Conditions
- Bipolar Disorder
- Keywords
- bipolar affective disorder, Smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tirat Carmel Mental Health CenterOther government
- Study start
- Aug 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 26 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.)
Detailed 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.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Unwillingness or inability to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: One interview session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2012.
- Derived from this study: PubMed 21664608Kreinin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anatoly Kreinin, MD, PHD principal investigator
B. Rappaport Faculty of Medicine, Technion, Haifa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by Tirat Carmel Mental Health Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: One interview session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00741299, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2012.