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| Sponsors and Collaborators: |
Emory University National Institute of Mental Health (NIMH) |
| Information provided by: | Emory University |
| ClinicalTrials.gov Identifier: | NCT00562861 |
Purpose
Bipolar depression is one of the least studied depressive illnesses. The standard practice for many doctors is to use antidepressant medicines, but there are few studies on the long-term results of these medicines. The goal of this study is to look at how effective and safe these medicines are in treating bipolar depression when taken with a mood stabilizer medicine.
The drug being studied is citalopram, also known as Celexa. Celexa is FDA approved for the treatment of major depression, but is not FDA approved for the treatment of bipolar depression. It is, however, standard practice for many doctors is to use antidepressants, like Celexa, to treat their patients with bipolar disorder depression.
The drug will be studied in three ways. We will see if it helps treat depressive symptoms. We will see how the drug affects the brain using PET and fMRI scans. Finally, we will look at the possibility that there may be a gene that could predict if a person would get better taking the drug using genetics.
| Condition | Intervention | Phase |
|
Bipolar Disorder Bipolar Depression |
Drug: citalopram + mood stabilizer Procedure: FDG PET scans Procedure: MRI structural scans Procedure: Genotyping Procedure: Blood Draw Drug: placebo + mood stabilizer |
Phase II Phase III |
| MedlinePlus related topics: | Antidepressants Bipolar Disorder Depression Nuclear Scans |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Treatment for Bipolar Depression: Acute & Prophylactic Efficacy With Citalopram |
| Estimated Enrollment: | 150 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Active Comparator
Mood stabilizer plus citalopram
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Drug: citalopram + mood stabilizer
Citalopram dose will be flexibly designed, beginning at 10 mg/d for at least one week, and the increased by 10 mg per week to a maximum of 50 mg/d. No target dose will be provided but rather clinicians will dose to clinical efficacy. Thus the study will provide clinicians data on the effective dose if it is positive. The dose will not be predetermined at static amounts.
Procedure: FDG PET scans
Two scans will be acquired in two separate PET imaging sessions, 6 weeks apart (baseline vs. end-of-acute treatment phase). The exploratory imaging component of this study will be limited to 60 individuals (30 in each arm) taking lithium as a sole mood stabilizer.
Procedure: MRI structural scans
MRI acquisitions will be acquired using a Siemens 3T whole body scanner (Trio) with a 60 cm diameter bore. Anatomical imaging will be conducted for anatomic reference for precise spatial normalization of co-registered PET images for the planned functional analyses. The exploratory imaging component of this study will be limited to 60 individuals (30 in each arm) taking lithium as a sole mood stabilizer.
Subjects will be asked to provide a blood sample at the start of the study for the genotyping portion of the study.
Procedure: Blood Draw
Subjects will have their blood drawn at the Emory Medical Labs at the same time as their safety labs are performed.
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2: Placebo Comparator
Mood stabilizer alone
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Procedure: FDG PET scans
Two scans will be acquired in two separate PET imaging sessions, 6 weeks apart (baseline vs. end-of-acute treatment phase). The exploratory imaging component of this study will be limited to 60 individuals (30 in each arm) taking lithium as a sole mood stabilizer.
Procedure: MRI structural scans
MRI acquisitions will be acquired using a Siemens 3T whole body scanner (Trio) with a 60 cm diameter bore. Anatomical imaging will be conducted for anatomic reference for precise spatial normalization of co-registered PET images for the planned functional analyses. The exploratory imaging component of this study will be limited to 60 individuals (30 in each arm) taking lithium as a sole mood stabilizer.
Subjects will be asked to provide a blood sample at the start of the study for the genotyping portion of the study.
Procedure: Blood Draw
Subjects will have their blood drawn at the Emory Medical Labs at the same time as their safety labs are performed.
Drug: placebo + mood stabilizer
This arm will only receive mood stabilizing medication. All subjects will be required to receive treatment with lithium, lamotrigine, valproate, or carbamazepine for at least one month at therapeutic blood levels or doses before randomization, or they must initiate one of these agents at study entry.
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Georgia | |||||
| Emory University School of Medicine: Wesley Woods Health Center | |||||
| Atlanta, Georgia, United States, 30322 | |||||
| United States, Massachusetts | |||||
| Tufts University | |||||
| Boston, Massachusetts, United States, 02111 | |||||
| Emory University |
| National Institute of Mental Health (NIMH) |
| Principal Investigator: | Nassir Ghaemi, MD, MPH | Tufts University Medical |
More Information
| Responsible Party: | Tufts Medical Center ( Nassir Ghaemi ) |
| Study ID Numbers: | MH78060-01A1, MH-0708060-01 |
| First Received: | November 20, 2007 |
| Last Updated: | July 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00562861 |
| Health Authority: | United States: Institutional Review Board |
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