Bipolar DisorderNCT01282281
Prospective Metabolic Monitoring of Youth and Adults With Bipolar Disorder
An observational study of Bipolar Disorder and Youth, run by Dr. Ayal Schaffer at 1 site in Canada.
Trial summary
Background: Most psychotropic medications that are effective in the treatment of Bipolar Disorder (BD) are associated with endocrine-metabolic changes (EMCs). To date, there is no long-term study in BD that has examined specifically the association of inflammation with EMCs in BD. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Bipolar Disorder, Youth, Adults
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Sep 2013
- 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 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Thirty adolescent participants with BD (type I, II, or not otherwise specified), and 30 adult participants with BD will be enrolled. Participants with BD will be recruited from the Youth and Adult Mood Disorder Clinics. Psychiatry Division staff will identify patients who meet the study criteria during weekly treatment team meetings. New referrals will also be screened to identify potential participants.
Who may be able to join
- Provision of written informed consent
- Diagnosis of BD type I, II, or NOS as determined by DSM-IV diagnostic criteria (confirmed using SCID or K-SADS)
- Both females and males, age14 to 65 years
- Decision by physician and patient to initiate pharmacotherapy with a traditional mood stabilizer or atypical antipsychotic
- Able to understand and comply with requirements of the study
- Proficient in English.
Who cannot join
- A primary psychiatric disorder other than bipolar disorder I, II or NOS (comorbid Axis I or II disorders are permitted, as long as clinician judges that bipolar disorder is the primary condition)
- Initiation of an antipsychotic, mood stabilizer or other medication with known endocrine-metabolic effects within 4 weeks prior to baseline visit
- Patients who, in the investigators opinion, are unlikely to adhere to pharmacotherapy for at least 4 weeks after baseline visit
- Significant medical condition that would contraindicate the use of mood stabilizers or atypical antipsychotics
- Patients who are receiving pharmacological treatment for diabetes mellitus (DM), hyperlipidemia, or obesity
- Acute or chronic medical illness (e.g. urinary tract infection, bronchitis, rheumatoid arthritis) that, as judged by the investigator, would significantly alter inflammatory, metabolic, or endocrine indices
- Screening bloodwork that identifies any other clinically significant deviation from the reference range in clinical laboratory test results, as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Metabolic Monitoring of Youth and Adults With Bipolar Disorder.
Background: Most psychotropic medications that are effective in the treatment of Bipolar Disorder (BD) are associated with endocrine-metabolic changes (EMCs). To date, there is no long-term study in BD that has examined specifically the association of inflammation with EMCs in BD. Specific aims: 1) to identify predictors of EMCs among adolescents and adults with BD who are being started on a medication ; 2) to compare change in EMCs in youth and adults treated for BD; 3) to measure change in EMCs associated with use of different medications for BD. Research Design: Participants: 30 adolescents (14-18 years old) with BD and 30 adults (19-65 years old) with BD. Measures: Blood levels of biomarkers that are associated with EMCs will be measured.
- Conditions
- Bipolar Disorder, Youth, Adults
- Keywords
- Bipolar Disorder, Youth, Adults, Endocrine-metabolic changes
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Individuals aged 14-18 and 19-65 with a diagnosis of BD | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in metabolic syndrome components
i.e. weight glucose, lipids, blood pressure, etc.
Measured: Screening, week 4/visit 2, week 12/visit 3, week 52/final visit
Secondary outcomes (1)
Cytokines, Chemokines, Insulin, Prolactin, Thyroid Hormone
- Cytokines include: pro-inflammatory markers such as c-reactive protein, interleukin-6, and tumor-necrosis factor alpha; anti-inflammatory cytokines include interleukin-4
- Chemokines include: Leptin, Ghrelin and Adiponectin
Measured: Screening, week 4/visit 2, week 12/visit 3, week 52/final visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Ayal Schaffer
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor-investigator, Dr. Ayal Schaffer, Sunnybrook Health Sciences Centre
- Investigators
- Ayal Schaffer, MD, Principal investigator, Sunnybrook Health Sciences CentreBenjamin Goldstein, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282281
- Sponsor's protocol ID
- WS688773
- Status last verified
- Jan 2014
- First submitted
- 21 Jan 2011
- Last updated
- 17 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Metabolic Monitoring of Youth and Adults With Bipolar Disorder.
- ClinicalTrials.gov ID
- NCT01282281
- Acronym / sponsor ID
- WS688773
- Conditions
- Bipolar Disorder, Youth, Adults
- Keywords
- Bipolar Disorder, Youth, Adults, Endocrine-metabolic changes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Dr. Ayal SchafferUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 24 Jan 2011 (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.
Background: Most psychotropic medications that are effective in the treatment of Bipolar Disorder (BD) are associated with endocrine-metabolic changes (EMCs). To date, there is no long-term study in BD that has examined specifically the association of inflammation with EMCs in BD. Specific aims: 1) to identify predictors of EMCs among adolescents and adults with BD who are being started on a medication ; 2) to compare change in EMCs in youth and adults treated for BD; 3) to measure change in EMCs associated with use of different medications for BD. Research Design: Participants: 30 adolescents (14-18 years old) with BD and 30 adults (19-65 years old) with BD. Measures: Blood levels of biomarkers that are associated with EMCs will be measured.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals aged 14-18 and 19-65 with a diagnosis of BD | – | – |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Thirty adolescent participants with BD (type I, II, or not otherwise specified), and 30 adult participants with BD will be enrolled. Participants with BD will be recruited from the Youth and Adult Mood Disorder Clinics. Psychiatry Division staff will identify patients who meet the study criteria during weekly treatment team meetings. New referrals will also be screened to identify potential participants.
Key inclusion criteria (6 listed)
- Provision of written informed consent
- Diagnosis of BD type I, II, or NOS as determined by DSM-IV diagnostic criteria (confirmed using SCID or K-SADS)
- Both females and males, age14 to 65 years
- Decision by physician and patient to initiate pharmacotherapy with a traditional mood stabilizer or atypical antipsychotic
- Able to understand and comply with requirements of the study
Key exclusion criteria (7 listed)
- A primary psychiatric disorder other than bipolar disorder I, II or NOS (comorbid Axis I or II disorders are permitted, as long as clinician judges that bipolar disorder is the primary condition)
- Initiation of an antipsychotic, mood stabilizer or other medication with known endocrine-metabolic effects within 4 weeks prior to baseline visit
- Patients who, in the investigators opinion, are unlikely to adhere to pharmacotherapy for at least 4 weeks after baseline visit
- Significant medical condition that would contraindicate the use of mood stabilizers or atypical antipsychotics
- Patients who are receiving pharmacological treatment for diabetes mellitus (DM), hyperlipidemia, or obesity
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
Change in metabolic syndrome components
Time frame: Screening, week 4/visit 2, week 12/visit 3, week 52/final visit
i.e. weight glucose, lipids, blood pressure, etc.
1 secondary outcome
Cytokines, Chemokines, Insulin, Prolactin, Thyroid Hormone
Time frame: Screening, week 4/visit 2, week 12/visit 3, week 52/final visit
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 17 Jan 2014.
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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.
Ayal Schaffer, MD principal investigator
Sunnybrook Health Sciences Centre
Benjamin Goldstein, MD principal investigator
Sunnybrook Health Sciences Centre
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 and Youth, run by Dr. Ayal Schaffer at 1 site in Canada.
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 6 inclusion and 7 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 17 Jan 2014. 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 Canada. 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?
Change in metabolic syndrome components (time frame: Screening, week 4/visit 2, week 12/visit 3, week 52/final visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2014.