N/A
N=76
PET and MRI Brain Imaging of Bipolar Disorder
Bipolar Disorder · Bipolar Depression · Unipolar Depression
Bottom Line
View on ClinicalTrials.gov: NCT01880957 ↗Enrolled (actual)
76
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Post-Lithium Treatment Hamilton Depression Rating Scale (HDRS) — -44.49 Percent Change in HDRS-24 Score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lithium (Drug); Lamotrigine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stony Brook University
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-Lithium Treatment Hamilton Depression Rating Scale (HDRS) |
-44.49 | — |
| PRIMARY Prediction of Treatment Response |
71.4; 85.7; 84.6; 77.8; 87.5; 87.5 | — |
| SECONDARY Group Differences in 5-HTT Binding Potential |
93.27; 88; 88.70; 264.82; 81.73; 181.13 | — |
| SECONDARY Group Differences in 5-HT1A Binding Potential |
8.91; 9.62; 8.57; 12.48; 14.88; 15.79 | — |
| SECONDARY Relationship Between Change in 5-HTT or 5-HT1A Binding Potential Pre- to Post Treatment and Lithium Treatment Response |
0.061; NA; NA; 0.086; NA; 0.073 | — |
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.
Eligibility Criteria
PATIENTS
BIPOLAR
Inclusion Criteria
- Bipolar patients suffering from a major depressive episode currently or recently (in the month prior to scanning). Patients on psychiatric medication will have failed their current regimen for the treatment of their depression: they will meet criteria for depression, be seeking treatment for it, and have been on an adequate dose of antidepressant or mood stabilizer (as defined by the Antidepressant Treatment Form-see Oquendo et al., 2003) for 4 weeks or more.
- Of sufficient severity to score at least 15 on the first 17 items of the Hamilton Depression Rating Scale or a score of 10 to 14 on the first 17 items of the Hamilton Depression Scale in conjunction with a score of at least 29 on the Beck Depression Inventory.
- Age range 18-65 years.
- Off all psychotropic and other types of drugs likely to interact with serotonin transporters and 5-HT1A receptors for at least 21 days. Allowed short-acting benzodiazepines for distressing anxiety or insomnia (up to 24 hours prior to each PET scan). Patients will be off neuroleptics for 3 weeks and off fluoxetine for 6 weeks prior to study. Off serotonin depleting drugs such as reserpine for 3 months. Patient will also be off anti-coagulant/anti-platelet treatment such as coumadin, with the exception of aspirin for 10 days.
- Willing to travel for PET scanning
Exclusion Criteria
- Other major psychiatric disorders such as schizophrenia, schizoaffective illness; current drug or alcohol abuse (within past 2 months), or drug or alcohol dependence = 900 mgs) for at least 4 weeks.
- Patient is unlikely to be able to tolerate medication washout
- Claustrophobia
- Blood donation within 8 weeks of the start of the study.
- History of bleeding disorder or are currently taking anticoagulants.
UNIPOLAR
Inclusion:
- Unipolar patients suffering from a major depressive episode currently or recently (in the month prior to scanning). Patients on psychiatric medication will have failed their current regimen for the treatment of their depression: they will meet criteria for depression, be seeking treatment for it, and have been on an adequate dose of antidepressant or mood stabilizer (as defined by the Antidepressant Treatment Form-see Oquendo et al., 2003) for 4 weeks or more.
- Of sufficient severity to score at least 15 on the first 17 items of the Hamilton Depression Rating Scale or a score of 10 to 14 on the first 17 items of the Hamilton Depression Scale in conjunction with a score of at least 29 on the Beck Depression Inventory.
- Age range 18-65 years.
- Off all psychotropic and other types of drugs likely to interact with serotonin transporters and 5-HT1A receptors for at least 21 days. Allowed short-acting benzodiazepines for distressing anxiety or insomnia (up to 24 hours prior to each PET scan). Patients will be off neuroleptics for 3 weeks and off fluoxetine for 6 weeks prior to study. Off serotonin depleting drugs such as reserpine for 3 months. Patient will also be off anti-coagulant/anti-platelet treatment such as coumadin, with the exception of aspirin for 10 days.
- Willing to travel for PET scanning
Exclusion:
- Other major psychiatric disorders such as schizophrenia, schizoaffective illness; current drug or alcohol abuse (within past 2 months), or drug or alcohol dependence = 900 mgs) for at least 4 weeks.
- Patient is unlikely to be able to tolerate medication washout
- Claustrophobia
- Blood donation within 8 weeks of the start of the study.
- History of bleeding disorder or are currently taking anticoagulants.
- Past unsuccessful treatment of Lithium of adequate dose and duration.
HEALTHY CONTROLS
Inclusion:
- No lifetime history of Axis I disorders
- Age range 18-65 years.
- Willing to travel for PET scanning.
Exclusion:
- Past or present alcohol/substance abuse or dependence; IV drug use or ecstasy use more than two times.
- A first-degree relative with history of major depression, schizophrenia, schizoaffective disorder, or s
Data sourced from ClinicalTrials.gov (NCT01880957). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.