Bipolar DisorderNCT01880957
PET and MRI Brain Imaging of Bipolar Disorder
A study testing Lithium and Lamotrigine in people with Bipolar Disorder and Bipolar Depression, run by Stony Brook University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Bipolar Depression, Unipolar Depression
- What is being tested?
- Lithium and Lamotrigine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2011to 23 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 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.
Show all 13Show fewer
- 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
- No lifetime history of Axis I disorders
- Age range 18-65 years.
- Willing to travel for PET scanning.
Who cannot join
- 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.
Show all 50Show fewer
- 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
- 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
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Brook University Hospital
Stony Brook, New York, 11794
About this study
Official title: Pathophysiology and Treatment of Bipolar Disorder as Assessed by in Vivo Imaging
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.
Read the 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.
- Conditions
- Bipolar Disorder, Bipolar Depression, Unipolar Depression
- Being tested
- Lithium, Lamotrigine
- Keywords
- bipolar disorder, bipolar depression, serotonin transporter, serotonin receptors, binding potential, brain imaging, unipolar depression
- Medical subject headings
- Bipolar Disorder, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LithiumDrug
Also called lithium carbonate
LamotrigineDrug
Also called Lamictal
| Study group | Role | What they receive |
|---|---|---|
| Lithium | Other | 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 Receives: Drug: Lithium |
| Lamotrigine | Other | 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. Receives: Drug: Lamotrigine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 weeks
Prediction of Treatment Response
Outcome measures were generated following LASSO linear regression analysis using pretreament HDRS-24 AND..
- pre-treatment 5-HTT OR
- pretreatment 5-HT1A OR
- 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.
Measured: 8 Weeks
Secondary outcomes (3)
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.
Measured: 8 Weeks
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.
Measured: 8 Weeks
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study start8 Nov 2011
- Primary completion23 Jun 2017
- Study completion23 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), The Dana Foundation
- Responsible party
- Principal investigator, Ramin Parsey, Stony Brook University
- Investigators
- Ramin Parsey, MD, PhD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880957
- Sponsor's protocol ID
- 2012-1826-F
- Other IDs
- 7R01MH090276-03
- Status last verified
- Jul 2022
- First submitted
- 17 Jun 2013
- Last updated
- 20 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ananth M, Bartlett EA, DeLorenzo C, Lin X, Kunkel L, Vadhan NP, Perlman G, Godstrey M, Holzmacher D, Ogden RT, Parsey RV, Huang C. Prediction of lithium treatment response in bipolar depression using 5-HTT and 5-HT1A PET. Eur J Nucl Med Mol Imaging. 2020 Sep;47(10):2417-2428. doi: 10.1007/s00259-020-04681-6. Epub 2020 Feb 13.
PubMed 32055965
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiology and Treatment of Bipolar Disorder as Assessed by in Vivo Imaging
- ClinicalTrials.gov ID
- NCT01880957
- Acronym / sponsor ID
- 2012-1826-F
- Conditions
- Bipolar Disorder, Bipolar Depression, Unipolar Depression
- Keywords
- bipolar disorder, bipolar depression, serotonin transporter, serotonin receptors, binding potential, brain imaging, unipolar depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), The Dana Foundation
- Study start
- 8 Nov 2011 (actual)
- Primary completion
- 23 Jun 2017 (actual)
- Study completion
- 23 Jun 2017 (actual)
- First posted
- 19 Jun 2013 (estimated)
- Results
- Posted 29 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lithium | Other | Drug: LithiumPatients 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 |
| Lamotrigine | Other | Drug: LamotriginePatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (50 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LithiumAlso: lithium carbonate | Drug | Lithium |
| LamotrigineAlso: Lamictal | Drug | Lamotrigine |
Primary outcome
Post-Lithium Treatment Hamilton Depression Rating Scale (HDRS)
Time frame: 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
Time frame: 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.
3 secondary outcomes
Group Differences in 5-HTT Binding Potential
Time frame: 8 Weeks
Group Differences in 5-HT1A Binding Potential
Time frame: 8 Weeks
Relationship Between Change in 5-HTT or 5-HT1A Binding Potential Pre- to Post Treatment and Lithium Treatment Response
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32055965Ananth M, Bartlett EA, DeLorenzo C, Lin X, Kunkel L, Vadhan NP, Perlman G, Godstrey M, Holzmacher D, Ogden RT, Parsey RV, Huang C. Prediction of lithium treatment response in bipolar depression using 5-HTT and 5-HT1A PET. Eur J Nucl Med Mol Imaging. 2020 Sep;47(10):2417-2428. doi: 10.1007/s00259-020-04681-6. Epub 2020 Feb 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramin Parsey, MD, PhD principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lithium and Lamotrigine in people with Bipolar Disorder and Bipolar Depression, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 50 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Lithium Treatment Hamilton Depression Rating Scale (HDRS) (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01880957, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.