Depression, BipolarNCT00608296
Functional and Neurochemical Brain Changes Bipolar Depression
An observational study of Depression, Bipolar, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of the research is to study brain structure, function and chemistry of patients with bipolar disorder who are receiving quetiapine or lithium, in order to better understand who benefits from treatment and why they respond to medications. Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- Depression, Bipolar
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jul 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 12 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: You are being asked to take part in this research study because you have been diagnosed with bipolar disorder and are currently experiencing a depressive episode. Bipolar disorder is an illness characterized by recurrent mood swings including mania, (periods of elation, excessive excitement, irritability, high energy, racing thoughts, poor sleep, poor judgment, reckless behavior) and clinical depression (periods of depressed mood, loss of interest in activities and disruption of sleep, appetite and energy). To participate in this study you must be at least 12 years old, and no older than 35.
Inclusion Criteria - Depressed bipolar patients (N=100; 15-20 patients/year):
- Patients will meet DSM-IV criteria for type I bipolar disorder, depressed, as determined by structured interview and best-estimate diagnostic procedures.138
- Patient has experienced a maximum of three documented affective episodes.
- Patient has been off medications for one week prior to study enrollment.
- Patient has a Hamilton Depression Rating Scale (HDRS) total score ≥20
- Patient is between the ages of 12 and 35 years.
Exclusion criteria: All subjects will be excluded from participation for the following reasons:
- Any chemical use disorder within 3 months.
- Any history of significant suicidality that would place the patient at risk to participate in this protocol.
- Current score ≥3 on item 3 of the HDRS-17 (Suicide Item)
- Any medical or neurological disorder that could influence fMRI results.
- A history of mental retardation or an estimated IQ total score <85.
- An MRI scan is contraindicated in the subject for any reason.
- The patient lives >100 miles from the University of Cincinnati or cannot attend follow-up visits.
- Meets DSM-IV criteria for a bipolar mixed episode
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati
Cincinnati, Ohio, 45267-0559
About this study
Official title: Functional and Neurochemical Brain Changes Following Successful Treatment of Early Course Bipolar Depression
The purpose of the research is to study brain structure, function and chemistry of patients with bipolar disorder who are receiving quetiapine or lithium, in order to better understand who benefits from treatment and why they respond to medications.
- Conditions
- Depression, Bipolar
- 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 |
|---|---|---|
| 1 | Study subjects on lithium | |
| 2 | study subjects on quetiapine |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, BipolarStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Caleb M. Adler, University of Cincinnati
- Investigators
- Caleb M Adler, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608296
- Sponsor's protocol ID
- BITREC - Project II
- Status last verified
- Dec 2014
- First submitted
- 23 Jan 2008
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Neurochemical Brain Changes Following Successful Treatment of Early Course Bipolar Depression
- ClinicalTrials.gov ID
- NCT00608296
- Acronym / sponsor ID
- BITREC - Project II
- Conditions
- Depression, Bipolar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jan 2008
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 6 Feb 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 the research is to study brain structure, function and chemistry of patients with bipolar disorder who are receiving quetiapine or lithium, in order to better understand who benefits from treatment and why they respond to medications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Study subjects on lithium |
| 2 | – | –study subjects on quetiapine |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- You are being asked to take part in this research study because you have been diagnosed with bipolar disorder and are currently experiencing a depressive episode. Bipolar disorder is an illness characterized by recurrent mood swings including mania, (periods of elation, excessive excitement, irritability, high energy, racing thoughts, poor sleep, poor judgment, reckless behavior) and clinical depression (periods of depressed mood, loss of interest in activities and disruption of sleep, appetite and energy). To participate in this study you must be at least 12 years old, and no older than 35.
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
Not reported in the source record.
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 23 Dec 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.
Caleb M Adler, MD principal investigator
University of Cincinnati
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 Depression, Bipolar, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 23 Dec 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 United States. 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.
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 23 Dec 2014.