PET and MRI Brain Imaging of Bipolar Disorder
The primary aims of this study are to:
- Quantify serotonin transporter (5-HTT) binding potential (BP) in vivo in bipolar disorder patients (BPD) during a major depressive episode (MDE).
- Assess the effect of lithium treatment of bipolar disorder on 5-HTT.
- Assess the effect of lithium treatment of bipolar disorder on 5-HT1A BP.
- Assess the effect of lamotrigine treatment of bipolar disorder on 5-HTT and 5-HT1A BP.
- Assess the effect of lithium treatment of unipolar depression on 5-HTT BP.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Pathophysiology and Treatment of Bipolar Disorder as Assessed by in Vivo Imaging|
- Hamilton Depression Rating Scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Patients will have a Hamilton Depression Rating Scale (HDRS) score obtained at baseline; participants must have an HDRS score of at least 15 to be eligible. After 6 weeks of medication treatment, the HDRS score will be reevaluated. Participants who have a 50% or greater decrease in their HDRS score will be considered responders and will proceed to the repeat PET scans.
|Study Start Date:||August 2012|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Patients in this condition will receive lithium administered as follows: Day 1, 2 and 3, 300 mg bid; Days 4-7 lithium 300 qam and 600 qhs. Lithium level will be checked as close to Day 7 as possible and titrated to a therapeutic plasma level of 0.8-1.2 mEq/l. Subjects will not undergo lithium monotherapy if they have a documented history of at least two failed trials of lithium of at least 4 weeks duration with therapeutic blood levels for a major depressive episode
Other Name: lithium carbonate
Patients who have not respond to adequate prior lithium treatment while depressed, or who refuse lithium, will be given lamotrigine. Lamotrigine will be started at 25 mg bid and increased to 50 mg bid after 2 weeks and again increased to 100 mg bid after an additional 2 weeks.
Other Name: Lamictal
PET and MRI imaging will be used to investigate the aims described above in patients who have bipolar disorder or unipolar depression and are currently experiencing a depressive episode. Both healthy controls and depressed participants with bipolar disorder or unipolar depression will be recruited. Patients who are on medication before enrolling in the study will have a three week washout. At baseline, healthy controls and patients will have an MRI consisting of both structural and functional sequences. Psychological measures will also be obtained at baseline. Within one week of the MRI, both patients and healthy controls will have one CUMI and one DASB PET scan.
Following the baseline PET scans, patient participants will begin medication treatment with either lithium or lamotrigine, based on the clinical judgement of the treating psychiatrist. Psychological measures will be obtained every 2 weeks. After 6 weeks of medication treatment at a therapeutic dose, patients will be assessed for remission (defined as a 50% decrease in the HDRS score from baseline). If this criteria is met, patient participants will then have follow-up PET scans (one CUMI and one DASB). If this criteria is not met, the patient will be switched to the other medication under study and will be reevaluated after an additional 4 weeks of medication treatment. Patients who still do not demonstrate a 50% decrease in their HDRS will be considered non-responders and will have repeat CUMI and DASB scans.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01880957
|Contact: Kalynn Gruenfelder, BA||631 638 2053||Kalynn.Gruenfelder@stonybrookmedicine.edu|
|United States, New York|
|Stony Brook University||Recruiting|
|Stony Brook, New York, United States, 11794|
|Principal Investigator: Ramin Parsey, MD, PhD|
|Principal Investigator:||Ramin Parsey, MD, PhD||Stony Brook University|