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NCT01880957 · ClinicalTrials.gov registry record · NA
PET and MRI Brain Imaging of Bipolar Disorder
A NA study, sponsored by Stony Brook University.
- Completed
- Registry status
- NA
- Development phase
- 76
- Enrollment target
NCT01880957: Completed NA study, sponsored by Stony Brook University.
NCT01880957 is a NA study that has completed, run by Stony Brook University. The registered enrollment target is 76 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01880957, a NA study, has completed, sponsored by Stony Brook University.
- COMPLETED
- Registry status
- NA
- Development phase
- 76 participants
- Enrollment target
Study Summary
The primary aims of this study are to: 1. Quantify serotonin transporter (5-HTT) binding potential (BP) in vivo in bipolar disorder patients (BPD) during a major depressive episode (MDE). 2. Assess the effect of lithium treatment of bipolar disorder on 5-HTT. 3. Assess the effect of lithium treatment of bipolar disorder on 5-HT1A BP. 4. Assess the effect of lamotrigine treatment of bipolar disorder on 5-HTT and 5-HT1A BP. 5. Assess the effect of lithium treatment of unipolar depression on 5-HTT BP.
Primary Outcome
Patients will have a Hamilton Depression Rating Scale-24 (HDRS) score obtained at baseline. Minimum score 0, maximum possible score 75; the higher the score on the scale, the more severe the degree of depression. Participants must have an HDRS score of at least 15 to be eligible. After eight weeks of medication treatment, the HDRS score will be reevaluated with the HDRS-24 (and rescanned with PET and MRI). Participants who have a 50% or greater decrease in their HDRS-24 score will be considered
Interventions
- DRUG Lamotrigine
- DRUG Lithium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2011-11-08 |
| Est. Completion | 2017-06-23 |
| Phase | NA |
What the finished NCT01880957 record still lists
NCT01880957 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Lamotrigine is the first listed.
NCT01880957 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01880957 about?
NCT01880957 is a clinical study titled "PET and MRI Brain Imaging of Bipolar Disorder". The primary aims of this study are to: 1. Quantify serotonin transporter (5-HTT) binding potential (BP) in vivo in bipolar disorder patients (BPD) during a major depressive episode (MDE). 2. Assess the effect of lithium treatment of bipolar disorder on 5-HTT. 3. Assess the effect of lithium treatme...
What is the current status of trial NCT01880957?
This trial is currently completed. It is a NA study. The enrollment target is 76 participants. The study started on 2011-11-08. Estimated completion is 2017-06-23.
What interventions are being tested in trial NCT01880957?
The interventions under investigation include: Lamotrigine (DRUG), Lithium (DRUG).
Who is sponsoring clinical trial NCT01880957?
This trial is sponsored by Stony Brook University, which has 127 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01880957's enrollment target sits among peer trials
76 1062nd of 2000 higher than 932 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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