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Bipolar disorder is a common condition that can cause significant disability and risk for suicide. Second generation antipsychotic medications can be used to treat depression in bipolar disorder, yet we do not know how they work. Here, we will use a recently approved medication, cariprazine (Vraylar), to treat participants with bipolar depression. They will have brain imaging with PET scans before and during treatment to understand how the medication may be working. Particularly, we will look at the role of the D3 dopamine receptor.
Full description
Bipolar disorder is a common and disabling condition with a high rate of suicide. The depressed phase of the disorder accounts for most of the morbidity and mortality. Only four medications are FDA approved to treat bipolar depression. They all include a second generation antipsychotic (SGA), yet the antidepressant mechanism of SGA's is unknown. Not all bipolar patients respond to these treatments, and they can have problematic side effects. There is therefore a great need to understand these medications' antidepressant mechanism of action in order to design more effective treatment options.
This will be an exploratory occupancy study with cariprazine (Vraylar) in unmedicated participants with bipolar depression (n=8). Participants will have [11C]-(+)-PHNO scans before treatment starts, after three weeks of cariprazine, and after six weeks. Participants will be randomized to two dose groups, 1.5 mg daily (n=4) and 3 mg daily (n=4). These are typical doses of the medication for bipolar depression. Serum levels of cariprazine will be measured at each PET scan.
Enrollment
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Inclusion criteria
Exclusion criteria
Diagnosis of any other major psychiatric disorders such as schizoaffective disorder, current psychotic depression. Any recent drug or alcohol use disorder; within 3 months before the study unless mild. Participant meets DSM5 criteria for manic episode at the time of screening, or has YMRS > 12.
Previous failed trial of cariprazine, defined by at least six weeks of treatment at the dose of 1.5 mg per day or more. Experienced intolerable side effects of cariprazine in the past. Taking any medications that are either contraindicated or that have clinically significant drug-drug interactions (such as strong CYP3A4 inducers) with cariprazine, unless there is a plan to stop these as part of the washout.
History of clinical deterioration when any of the medications that the participant is taking at presentation have been discontinued in the past if they will be discontinued as part of the washout.
First-degree family history of schizophrenia if the participant is less than 33 years old.
Significant active physical illness, including blood dyscrasias, lymphomas, hypersplenism, endocrinopathies, renal failure, chronic obstructive lung disease, autonomic neuropathies, peripheral vascular disease, neuromuscular disorder or tardive dyskinesia. Any medical diagnoses that would be a contraindication to cariprazine treatment, including any movement disorders. Any history of a seizure disorder.
Actively suicidal, as defined by expressive ideation with a plan and intent for suicide, or developing suicidal ideation that requires immediate medical or treatment intervention.
Active lactation
Electroconvulsive therapy within the past 6 months
Participants who endorse a history of prior head trauma and score 1.5 standard deviations below the mean of Trailmaking A & B test
Metal implants, cardiac pacemaker, metal prostheses, metal orthodontic appliances or shrapnel in the body unless there is confirmation that the substance is MRI compatible
Current, past or anticipated exposure to radiation, including:
A. Having been badged for radiation exposure in the workplace B. Participation in nuclear medicine protocols in the past year. However, participants will be eligible if the injected dose and dosimetry of the radiotracer used are known and the cumulative annual exposure of the previous study and this study is lower than the annual limit for research participants defined by FDA (21 CFR 361.1)
History of claustrophobia that would prevent participation in imaging scans.
Inadequate understanding of English
Weight >350 lbs or inability to fit into the MRI scanner
Primary purpose
Allocation
Interventional model
Masking
8 participants in 2 patient groups
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Central trial contact
Martin Lan, MD
Data sourced from clinicaltrials.gov
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