Bipolar Depression, Bipolar Disorder, Unipolar Depression
Conditions
Keywords
bipolar disorder, bipolar depression, serotonin transporter, serotonin receptors, binding potential, brain imaging, unipolar depression
Brief 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.
Detailed description
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.
Interventions
DRUGLithium
DRUGLamotrigine
Sponsors
National Institute of Mental Health (NIMH)
The Dana Foundation
Stony Brook University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion 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 \<6mos ago; anorexia nervosa or bulimia nervosa in the past year; IV drug use or ecstasy use more than two times. * A first-degree family history of schizophrenia if the subject is less than 33 years old (mean age of onset for schizophrenia plus two standard deviations). * Significant active physical illness particularly those that may affect the brain or serotonergic system including blood dyscrasias lymphomas, hypersplenism, endocrinopathies, renal failure or chronic obstructive lung disease, autonomic neuropathies, peripheral vascular disease, diabetes, low hemoglobin and malignancy, significant anemic disease or blood loss and the lab parameters platelet count \< 80,000. * Lacks capacity to consent. * Actively suicidal-begins expressing a plan for suicide during the washout phase or develop suicidal ideation that warrants admission or requires medication or treatment intervention. * Electroconvulsive therapy (ECT) within the past 6 months. * Pregnancy, currently lactating; planning to conceive during the course of study participation or abortion in the past two months. * Metal implants, pacemaker or metal prostheses or orthodontic appliances, the presence of shrapnel * Current, past or anticipated exposure to radiation, that may include: being badged for radiation exposure in the workplace, participation in nuclear medicine procedures, including research protocols in the last year. * A neurological disease or loss of consciousness for more than a few minutes * Medicinal Patch (participants will be asked to remove before MRI) * Patients who are responding satisfactorily to psychiatric medications, because they will not be washed-out for purposes of this study * A documented history of a lack of response to a trial of adequate dose and duration of both lithium and lamotrigine defined as minimal clinical response to lamotrigine 200 mgs for at least 4 weeks or lithium serum levels of at least 0.8 (or dose \>= 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 \<6mos ago; anorexia nervosa or bulimia nervosa in the past year; IV drug use or ecstasy use more than two times. * A first-degree family history of schizophrenia if the subject is less than 33 years old (mean age of onset for schizophrenia plus two standard deviations). * Significant active physical illness particularly those that may affect the brain or serotonergic system including blood dyscrasias lymphomas, hypersplenism, endocrinopathies, renal failure or chronic obstructive lung disease, autonomic neuropathies, peripheral vascular disease, diabetes, low hemoglobin and malignancy, significant anemic disease or blood loss and the lab parameters platelet count \< 80,000. * Lacks capacity to consent. * Actively suicidal-begins expressing a plan for suicide during the washout phase or develop suicidal ideation that warrants admission or requires medication or treatment intervention. * Electroconvulsive therapy (ECT) within the past 6 months. * Pregnancy, currently lactating; planning to conceive during the course of study participation or abortion in the past two months. * Metal implants, pacemaker or metal prostheses or orthodontic appliances, the presence of shrapnel * Current, past or anticipated exposure to radiation, that may include: being badged for radiation exposure in the workplace, participation in nuclear medicine procedures, including research protocols in the last year. * A neurological disease or loss of consciousness for more than a few minutes * Medicinal Patch (participants will be asked to remove before MRI) * Patients who are responding satisfactorily to psychiatric medications, because they will not be washed-out for purposes of this study * A documented history of a lack of response to a trial of adequate dose and duration of both lithium and lamotrigine defined as minimal clinical response to lamotrigine 200 mgs for at least 4 weeks or lithium serum levels of at least 0.8 (or dose \>= 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 suicide attempt; two or more first degree relatives with a history of substance dependence. * Significant active physical illness particularly those that may affect the brain or serotonergic system including blood dyscrasias lymphomas, hypersplenism, endocrinopathies, renal failure or chronic obstructive lung disease, autonomic neuropathies, peripheral vascular disease, diabetes, low hemoglobin and malignancy, significant anemic disease or blood loss, and the following lab parameters: platelet count \< 80,000 * Lacks capacity to consent * Pregnancy, currently lactating; planning to conceive during the course of study participation or abortion in the past two months * Metal implants, pacemaker or metal prostheses or orthodontic appliances, the presence of shrapnel * Current, past or anticipated exposure to radiation, that may include: being badged for radiation exposure in the workplace, participation in nuclear medicine procedures, including research protocols in the last year. * A neurological disease or loss of consciousness for more than a few minutes * Medicinal Patch (participants will be asked to remove before MRI) * Subjects on drugs or medication that affect the serotonin system * Claustrophobia * Blood donation within 8 weeks of the start of the study. * History of bleeding disorder or are currently taking anticoagulants.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-Lithium Treatment Hamilton Depression Rating Scale (HDRS) | 8 weeks | 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 responders (to Lithium treatment). |
| Prediction of Treatment Response | 8 Weeks | Outcome measures were generated following LASSO linear regression analysis using pretreament HDRS-24 AND.. 1. pre-treatment 5-HTT OR 2. pretreatment 5-HT1A OR 3. the combination of both 5-HTT and 5-HT1A binding potential * to predict post-treatment response defined by a dichotomous remission status variable (remitter vs. non-remitter, where remitter is defined a priori by HDRS-24 \<10 post-treatment and a reduction of greater than or equal to 50% in HDRS-24 pre-to-post treatment). Outcome measure is reported as percent accuracy, sensitivity, or specificity in predicting remitter status outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Group Differences in 5-HTT Binding Potential | 8 Weeks | Differences in mean of 5-HTT binding potential between patients with depression pre-treatment, post-treatment, compared to healthy volunteers. Broadly, binding potential is defined as the ratio of the tracer concentration in tissue to the free plasma concentration. It is a measure of the density of available targets (e.g. 5-HTT) & the affinity of the ligand (tracer) to that target. |
| Group Differences in 5-HT1A Binding Potential | 8 Weeks | Differences in mean of 5-HT1A binding potential between patients with depression pre-treatment, post-treatment, compared to healthy volunteers. Broadly, binding potential is defined as the ratio of the tracer concentration in tissue to the free plasma concentration. It is a measure of the density of available targets (e.g. 5-HT1A) & the affinity of the ligand (tracer) to that target. |
| Relationship Between Change in 5-HTT or 5-HT1A Binding Potential Pre- to Post Treatment and Lithium Treatment Response | 8 weeks | Linear regression & correlation to assess the relationship between between change in binding potential pre- to post treatment vs. treatment response |
Countries
United States
Participant flow
Recruitment details
Dates of Recruitment: 11/2011 - 05/2017 Location: University Medical Centers (Columbia, Stony Brook University)
Pre-assignment details
1. Inclusion/Exclusion Criteria must be met prior to beginning study protocols. 2. Wash-out Period: For participants in the patient group, all were required to be 3 weeks medication free before beginning the study.
Participants by arm
| Arm | Count |
|---|---|
| Patients With Depression Patients with Bipolar depression 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
Lithium | 31 |
| Healthy Volunteers Participants in this group underwent baseline assessment for Hamilton Depression Rating Scale and Baseline PET and MRI Imaging. No treatment was provided for this group. | 23 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Diagnosis: Unipolar Depression | 12 | 0 |
| Overall Study | Lost to Follow-up | 11 | 0 |
| Overall Study | Poor Tolerance to Lithium/Declined Treatment | 5 | 0 |
Baseline characteristics
| Characteristic | Patients With Depression | Healthy Volunteers | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 23 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 7 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 16 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 0 Participants | 6 Participants |
| Hamilton Depression Rating Sale | 26.19 units on a scale STANDARD_DEVIATION 5.86 | 1.62 units on a scale STANDARD_DEVIATION 2.1 | 16.71 units on a scale STANDARD_DEVIATION 13.27 |
| Sex: Female, Male Female | 15 Participants | 12 Participants | 27 Participants |
| Sex: Female, Male Male | 16 Participants | 11 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 29 |
| other Total, other adverse events | 0 / 47 | 0 / 29 |
| serious Total, serious adverse events | 0 / 47 | 0 / 29 |
Outcome results
Primary
Post-Lithium Treatment Hamilton Depression Rating Scale (HDRS)
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 responders (to Lithium treatment).
Time frame: 8 weeks
Population: Pre-to-Post lithium treatment change in HDRS Score
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With BPD | Post-Lithium Treatment Hamilton Depression Rating Scale (HDRS) | -44.49 Percent Change in HDRS-24 Score | Standard Deviation 34.17 |
Primary
Prediction of Treatment Response
Outcome measures were generated following LASSO linear regression analysis using pretreament HDRS-24 AND.. 1. pre-treatment 5-HTT OR 2. pretreatment 5-HT1A OR 3. the combination of both 5-HTT and 5-HT1A binding potential * to predict post-treatment response defined by a dichotomous remission status variable (remitter vs. non-remitter, where remitter is defined a priori by HDRS-24 \<10 post-treatment and a reduction of greater than or equal to 50% in HDRS-24 pre-to-post treatment). Outcome measure is reported as percent accuracy, sensitivity, or specificity in predicting remitter status outcomes.
Time frame: 8 Weeks
Population: Remission status prediction by groups: accuracy, specificity, and sensitivity. The analyzed population here must have completed both pre- and post-treatment scans for BOTH 5-HTT and 5-HT1A and have 8 weeks of HDRS-24 followup so the predictive power of each individual tracer could be assessed as well as the combination of the two tracers. This is a smaller population that each tracer individually or the outcome of the HDRS-24 scale alone.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With BPD | Prediction of Treatment Response | Prediction Sensitivity= True positives divided by the sum of true positive and false negative | 60 Percentage |
| Patients With BPD | Prediction of Treatment Response | Prediction Specificity = True negatives divided by the sum of true negative and false positive | 77.8 Percentage |
| Patients With BPD | Prediction of Treatment Response | Prediction Accuracy = True positive + negative divided by the sum of true + false positive/negative | 71.4 Percentage |
| Prediction by Pre-treatment 5-HT1A | Prediction of Treatment Response | Prediction Specificity = True negatives divided by the sum of true negative and false positive | 87.5 Percentage |
| Prediction by Pre-treatment 5-HT1A | Prediction of Treatment Response | Prediction Accuracy = True positive + negative divided by the sum of true + false positive/negative | 85.7 Percentage |
| Prediction by Pre-treatment 5-HT1A | Prediction of Treatment Response | Prediction Sensitivity= True positives divided by the sum of true positive and false negative | 80 Percentage |
| Combinatorial Prediction Using Pre-Treatment 5-HTT & 5-HT1A | Prediction of Treatment Response | Prediction Accuracy = True positive + negative divided by the sum of true + false positive/negative | 84.6 Percentage |
| Combinatorial Prediction Using Pre-Treatment 5-HTT & 5-HT1A | Prediction of Treatment Response | Prediction Sensitivity= True positives divided by the sum of true positive and false negative | 60 Percentage |
| Combinatorial Prediction Using Pre-Treatment 5-HTT & 5-HT1A | Prediction of Treatment Response | Prediction Specificity = True negatives divided by the sum of true negative and false positive | 87.5 Percentage |
Secondary
Group Differences in 5-HT1A Binding Potential
Differences in mean of 5-HT1A binding potential between patients with depression pre-treatment, post-treatment, compared to healthy volunteers. Broadly, binding potential is defined as the ratio of the tracer concentration in tissue to the free plasma concentration. It is a measure of the density of available targets (e.g. 5-HT1A) & the affinity of the ligand (tracer) to that target.
Time frame: 8 Weeks
Population: Comparison of mean binding potential across patients pre-treatment, post-treatment, and controls.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With BPD | Group Differences in 5-HT1A Binding Potential | Raphe Nucleus | 8.91 Weighted Mean Binding Potential | Standard Error 3.15 |
| Patients With BPD | Group Differences in 5-HT1A Binding Potential | Parahippocampal Gyrus | 12.48 Weighted Mean Binding Potential | Standard Error 2.41 |
| Patients With BPD | Group Differences in 5-HT1A Binding Potential | Amygdala | 20.8 Weighted Mean Binding Potential | Standard Error 5.26 |
| Patients With BPD | Group Differences in 5-HT1A Binding Potential | Hippocampus | 27.06 Weighted Mean Binding Potential | Standard Error 8.4 |
| Prediction by Pre-treatment 5-HT1A | Group Differences in 5-HT1A Binding Potential | Hippocampus | 30.17 Weighted Mean Binding Potential | Standard Error 7.84 |
| Prediction by Pre-treatment 5-HT1A | Group Differences in 5-HT1A Binding Potential | Raphe Nucleus | 9.62 Weighted Mean Binding Potential | Standard Error 1.79 |
| Prediction by Pre-treatment 5-HT1A | Group Differences in 5-HT1A Binding Potential | Amygdala | 17.86 Weighted Mean Binding Potential | Standard Error 4.39 |
| Prediction by Pre-treatment 5-HT1A | Group Differences in 5-HT1A Binding Potential | Parahippocampal Gyrus | 14.88 Weighted Mean Binding Potential | Standard Error 3.13 |
| Combinatorial Prediction Using Pre-Treatment 5-HTT & 5-HT1A | Group Differences in 5-HT1A Binding Potential | Hippocampus | 28.39 Weighted Mean Binding Potential | Standard Error 7.73 |
| Combinatorial Prediction Using Pre-Treatment 5-HTT & 5-HT1A | Group Differences in 5-HT1A Binding Potential | Parahippocampal Gyrus | 15.79 Weighted Mean Binding Potential | Standard Error 3.75 |
| Combinatorial Prediction Using Pre-Treatment 5-HTT & 5-HT1A | Group Differences in 5-HT1A Binding Potential | Amygdala | 14.01 Weighted Mean Binding Potential | Standard Error 3.41 |
| Combinatorial Prediction Using Pre-Treatment 5-HTT & 5-HT1A | Group Differences in 5-HT1A Binding Potential | Raphe Nucleus | 8.57 Weighted Mean Binding Potential | Standard Error 2.58 |
Secondary
Group Differences in 5-HTT Binding Potential
Differences in mean of 5-HTT binding potential between patients with depression pre-treatment, post-treatment, compared to healthy volunteers. Broadly, binding potential is defined as the ratio of the tracer concentration in tissue to the free plasma concentration. It is a measure of the density of available targets (e.g. 5-HTT) & the affinity of the ligand (tracer) to that target.
Time frame: 8 Weeks
Population: Comparison of mean binding potential across patients pre-treatment, post-treatment, and controls.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With BPD | Group Differences in 5-HTT Binding Potential | Anterior Cingulate | 131.80 Weighted Mean Binding Potential | Standard Error 26.99 |
| Patients With BPD | Group Differences in 5-HTT Binding Potential | Midbrain | 264.82 Weighted Mean Binding Potential | Standard Error 32.47 |
| Patients With BPD | Group Differences in 5-HTT Binding Potential | Grey Matter of Cerebellum | 93.27 Weighted Mean Binding Potential | Standard Error 17.86 |
| Patients With BPD | Group Differences in 5-HTT Binding Potential | Amygdala | 198.56 Weighted Mean Binding Potential | Standard Error 27.64 |
| Prediction by Pre-treatment 5-HT1A | Group Differences in 5-HTT Binding Potential | Midbrain | 81.73 Weighted Mean Binding Potential | Standard Error 18.59 |
| Prediction by Pre-treatment 5-HT1A | Group Differences in 5-HTT Binding Potential | Grey Matter of Cerebellum | 88 Weighted Mean Binding Potential | Standard Error 1.87 |
| Prediction by Pre-treatment 5-HT1A | Group Differences in 5-HTT Binding Potential | Anterior Cingulate | 187.48 Weighted Mean Binding Potential | Standard Error 60.73 |
| Prediction by Pre-treatment 5-HT1A | Group Differences in 5-HTT Binding Potential | Amygdala | 116.94 Weighted Mean Binding Potential | Standard Error 28.73 |
| Combinatorial Prediction Using Pre-Treatment 5-HTT & 5-HT1A | Group Differences in 5-HTT Binding Potential | Anterior Cingulate | 130.04 Weighted Mean Binding Potential | Standard Error 30.73 |
| Combinatorial Prediction Using Pre-Treatment 5-HTT & 5-HT1A | Group Differences in 5-HTT Binding Potential | Midbrain | 181.13 Weighted Mean Binding Potential | Standard Error 90.2 |
| Combinatorial Prediction Using Pre-Treatment 5-HTT & 5-HT1A | Group Differences in 5-HTT Binding Potential | Grey Matter of Cerebellum | 88.70 Weighted Mean Binding Potential | Standard Error 21.71 |
| Combinatorial Prediction Using Pre-Treatment 5-HTT & 5-HT1A | Group Differences in 5-HTT Binding Potential | Amygdala | 166.73 Weighted Mean Binding Potential | Standard Error 61.75 |
Secondary
Relationship Between Change in 5-HTT or 5-HT1A Binding Potential Pre- to Post Treatment and Lithium Treatment Response
Linear regression & correlation to assess the relationship between between change in binding potential pre- to post treatment vs. treatment response
Time frame: 8 weeks
Population: Linear regression between change in PET binding potential pre and post treatment and treatment response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With BPD | Relationship Between Change in 5-HTT or 5-HT1A Binding Potential Pre- to Post Treatment and Lithium Treatment Response | R-Squared: 5-HTT Midbrain | 0.061 Percent Change in Binding Potential |
| Patients With BPD | Relationship Between Change in 5-HTT or 5-HT1A Binding Potential Pre- to Post Treatment and Lithium Treatment Response | R-Squared: 5-HT1A Raphe | NA Percent Change in Binding Potential |
| Patients With BPD | Relationship Between Change in 5-HTT or 5-HT1A Binding Potential Pre- to Post Treatment and Lithium Treatment Response | R-Squared: 5-HT1A Hippocampus | NA Percent Change in Binding Potential |
| Prediction by Pre-treatment 5-HT1A | Relationship Between Change in 5-HTT or 5-HT1A Binding Potential Pre- to Post Treatment and Lithium Treatment Response | R-Squared: 5-HTT Midbrain | NA Percent Change in Binding Potential |
| Prediction by Pre-treatment 5-HT1A | Relationship Between Change in 5-HTT or 5-HT1A Binding Potential Pre- to Post Treatment and Lithium Treatment Response | R-Squared: 5-HT1A Raphe | 0.086 Percent Change in Binding Potential |
| Prediction by Pre-treatment 5-HT1A | Relationship Between Change in 5-HTT or 5-HT1A Binding Potential Pre- to Post Treatment and Lithium Treatment Response | R-Squared: 5-HT1A Hippocampus | 0.073 Percent Change in Binding Potential |