Bipolar DepressionNCT01639482
Neuroimaging Studies of the Treatment of Bipolar Depression With Citalopram
An observational study of Bipolar Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Regional metabolic changes associated with response to 6 weeks of citalopram treatment, using 18-Fluorodeoxyglucose Positron Emission Tomography imaging, will be characterized (FDG PET). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Bipolar Depression
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Dec 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with Bipolar Depression
Who may be able to join
- Current age 18-64 years; DSM-IV diagnosis of BPD, type-I, or type-II; Enrolled in the Citalopram Study at Tufts Medical Center
Who cannot join
- Current pregnancy, or inability to utilize contraception, The presence of any metallic implants, History of claustrophobia
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital - East
Charlestown, Massachusetts, 02129
About this study
Regional metabolic changes associated with response to 6 weeks of citalopram treatment, using 18-Fluorodeoxyglucose Positron Emission Tomography imaging, will be characterized (FDG PET).
Read the detailed description
Regional metabolic changes associated with response to 6 weeks of citalopram treatment, using 18-Fluorodeoxyglucose Positron Emission Tomography imaging, will be characterized (FDG PET). The following hypothesis will be tested: Antidepressant response or remission in depressed BPD patients will be associated with changes in cortical (prefrontal, parietal, premotor) and paralimbic (hippocampus, anterior cingulate, subgenual cingulate, posterior cingulate, and anterior insula) regions, consistent with SRI antidepressant response in unipolar depressed patients.
- Conditions
- Bipolar Depression
- 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 |
|---|---|---|
| Citalopram | Patients with bipolar disorder | |
| Placebo | Patients with bipolar disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
rCMRglu
regional glucose metabolism
Measured: pre and post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startApr 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DepressionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darin Dougherty, Massachusetts General Hospital
- Investigators
- Darin D Dougherty, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639482
- Sponsor's protocol ID
- 2009P002712
- Status last verified
- Mar 2019
- First submitted
- 10 Jul 2012
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Studies of the Treatment of Bipolar Depression With Citalopram
- ClinicalTrials.gov ID
- NCT01639482
- Acronym / sponsor ID
- 2009P002712
- Conditions
- Bipolar Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 Jul 2012 (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.
Regional metabolic changes associated with response to 6 weeks of citalopram treatment, using 18-Fluorodeoxyglucose Positron Emission Tomography imaging, will be characterized (FDG PET).
Detailed description
Regional metabolic changes associated with response to 6 weeks of citalopram treatment, using 18-Fluorodeoxyglucose Positron Emission Tomography imaging, will be characterized (FDG PET). The following hypothesis will be tested: Antidepressant response or remission in depressed BPD patients will be associated with changes in cortical (prefrontal, parietal, premotor) and paralimbic (hippocampus, anterior cingulate, subgenual cingulate, posterior cingulate, and anterior insula) regions, consistent with SRI antidepressant response in unipolar depressed patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Citalopram | – | –Patients with bipolar disorder |
| Placebo | – | –Patients with bipolar disorder |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with Bipolar Depression
Key inclusion criteria (1 listed)
- Current age 18-64 years; DSM-IV diagnosis of BPD, type-I, or type-II; Enrolled in the Citalopram Study at Tufts Medical Center
Key exclusion criteria (1 listed)
- Current pregnancy, or inability to utilize contraception, The presence of any metallic implants, History of claustrophobia
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
rCMRglu
Time frame: pre and post-treatment
regional glucose metabolism
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 7 Mar 2019.
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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.
Darin D Dougherty, MD principal investigator
Massachusetts General Hospital
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 Depression, run by Massachusetts General Hospital 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?
The sponsor lists 1 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 7 Mar 2019. 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.
What does the primary outcome measure?
rCMRglu (time frame: pre and post-treatment). 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 7 Mar 2019.