Bipolar DepressionNCT02239094
Biosignatures of Latuda for Bipolar Depression
A study testing Lurasidone (Latuda) in people with Bipolar Depression, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The study proposes to conduct a pilot study of biological predictors of lurasidone response in bipolar depression. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bipolar Depression
- What is being tested?
- Lurasidone (Latuda)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Sep 2016
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18- 60
- Outpatients with a primary Diagnostic and Statistical Manual of the American Psychiatric Association, Fourth Edition (DSM-IV) diagnosis of Bipolar Disorder I, II, or NOS (Not Otherwise Specified)
- Current episode of Major Depression
- At least moderate severity of depression
- Agrees to, and is eligible for, electroencephalogram (EEG) / psychological testing, magnetic resonance imaging (MRI), and blood draws
- Provides informed consent
Who cannot join
- Current drug or alcohol abuse/dependence, except nicotine (within 6 months for dependence; 2 for abuse)
- Taking any of the following exclusionary medications: antipsychotics, anticonvulsants, mood stabilizers, stimulants, antidepressant medications, medications with significant interactions with lurasidone, except during the washout prior to testing and blood collection
- Unstable medical condition, including significant liver disease, hypothyroidism (i.e., condition not adequately stabilized for 3 months), and conditions likely to require hospitalization or with a life expectancy of < 6 mos.*
- Patients considered at significant risk for suicide
- Inadequate understanding of English
- Currently pregnant or breast-feeding; fecund women not using adequate contraceptive methods; plan to become pregnant within 12 months
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- Contraindications to MRI (e.g. ferromagnetic body implants, history of metal working, etc.)
- Have epilepsy, neuromuscular disorder, or tardive dyskinesia
- Require immediate hospitalization for psychiatric disorder
- Require medications for a general medical condition that contraindicate any study medication**
- Receiving or have received during the index episode vagus nerve stimulation, electroconvulsive therapy, transcranial magnetic stimulation, or other somatic treatments
- Allergy to, or other medical contraindication to lurasidone treatment
- Currently enrolled in another research study, and participation in that study contraindicates participation
- Clinically significant screening laboratory abnormalities (* see below)
- Currently taking an effective mood stabilizer and/or antidepressant regimen
- Inability to undergo a three week medication-free period, including history of significant clinical deterioration from past periods off medication or when medication dosage was reduced, including mania, severe depression, etc.
- Any reason not listed herein that would make participation in the study hazardous *Medical criteria for exclusion:
- Untreated hypertension: > 140/90 Torr on repeated measurement (If hypertension becomes stabilized, subject may enroll in study)
- Hepatitis: any liver function test > 2x the upper limit of normal
- Renal failure: estimated Glomerular Filtration Rate (eGFR, corrected for body surface area) repeatedly < 30 mL/min
- Hypothyroidism: thryrotropin stimulating hormone level > upper limit of normal (unless accompanied by other euthyroid indices and the confirmation by an internist or endocrinologist that this does not represent hypothyroidism)
- Anemia: hemoglobin < 10 grams/deciliter (borderline hemoglobin must be of known origin, stable, and not clinically significant)
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Identification of Biosignatures for Lurasidone (Latuda) Response in Bipolar Depression
The study proposes to conduct a pilot study of biological predictors of lurasidone response in bipolar depression.
Read the detailed description
The study proposes to enroll 20 participants with a bipolar disorder who are currently in an episode of major depression.Magnetic resonance imaging (MRI), recordings of brain electrical activity (EEG), and psychological testing to explore possible predictors of lurasidone treatment response will be conducted. Blood samples will be collected for a future study of blood protein predictors of response. After testing, participants will receive an open-label 8-week trial of lurasidone (Latuda™) at approved dosage levels. Participants who attain remission of their major depressive episode will be eligible for a six-month continuation phase to explore predictors of sustained response to continuation treatment. Data analyses will use statistical testing to explore potential biological predictors of lurasidone response. This will provide a framework for clarifying which patients are best suited to this treatment and begin to develop a model for precision treatment of this difficult-to-treat disorder.
- Conditions
- Bipolar Depression
- Being tested
- Lurasidone (Latuda)
- Keywords
- Bipolar Disorder, depression, Bipolar depression
- Medical subject headings
- Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lurasidone (Latuda)Drug
Also called Latuda
Antipsychotic medication approved for use with Bipolar disorder
| Study group | Role | What they receive |
|---|---|---|
| Lurasidone (Latuda) | Other | All study participants will receive open-label Latuda. Receives: Drug: Lurasidone (Latuda) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Rating Scale for Depression (MADRS)
The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression.
Nine of the items are based upon patient report, and one is on the rater's observation during the rating interview. MADRS items are rated on a 0-6 continuum (0=no abnormality, 6=severe).
Measured: Baseline
Montgomery-Asberg Rating Scale for Depression (MADRS) at Week8
The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression.
Nine of the items are based upon patient report, and one is on the rater's observation during the rating interview. MADRS items are rated on a 0-6 continuum (0=no abnormality, 6=severe).
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startJan 2015
- Primary completionSep 2016
- Study completionSep 2016
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 DepressionStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc.
- Responsible party
- Sponsor
- Investigators
- Patrick J McGrath, MD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02239094
- Sponsor's protocol ID
- #6954
- Other IDs
- 6954
- Status last verified
- Nov 2017
- First submitted
- 9 Sep 2014
- Last updated
- 12 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lan MJ, Pantazatos SP, Ogden RT, Rubin-Falcone H, Hellerstein D, McGrath PJ, Mann JJ. Resting State MRI Amplitude of Low Frequency Fluctuations Associated With Suicidal Ideation in Bipolar Depression. J Clin Psychiatry. 2022 Mar 30;83(3):21m14054. doi: 10.4088/JCP.21m14054.
PubMed 35377567
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Biosignatures for Lurasidone (Latuda) Response in Bipolar Depression
- ClinicalTrials.gov ID
- NCT02239094
- Acronym / sponsor ID
- #6954
- Conditions
- Bipolar Depression
- Keywords
- Bipolar Disorder, depression, Bipolar depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc.
- Study start
- Jan 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 12 Sep 2014 (estimated)
- Results
- Posted 13 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study proposes to conduct a pilot study of biological predictors of lurasidone response in bipolar depression.
Detailed description
The study proposes to enroll 20 participants with a bipolar disorder who are currently in an episode of major depression.Magnetic resonance imaging (MRI), recordings of brain electrical activity (EEG), and psychological testing to explore possible predictors of lurasidone treatment response will be conducted. Blood samples will be collected for a future study of blood protein predictors of response. After testing, participants will receive an open-label 8-week trial of lurasidone (Latuda™) at approved dosage levels. Participants who attain remission of their major depressive episode will be eligible for a six-month continuation phase to explore predictors of sustained response to continuation treatment. Data analyses will use statistical testing to explore potential biological predictors of lurasidone response. This will provide a framework for clarifying which patients are best suited to this treatment and begin to develop a model for precision treatment of this difficult-to-treat disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lurasidone (Latuda) | Other | Drug: Lurasidone (Latuda)All study participants will receive open-label Latuda. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18- 60
- Outpatients with a primary Diagnostic and Statistical Manual of the American Psychiatric Association, Fourth Edition (DSM-IV) diagnosis of Bipolar Disorder I, II, or NOS (Not Otherwise Specified)
- Current episode of Major Depression
- At least moderate severity of depression
- Agrees to, and is eligible for, electroencephalogram (EEG) / psychological testing, magnetic resonance imaging (MRI), and blood draws
Key exclusion criteria (22 listed)
- Current drug or alcohol abuse/dependence, except nicotine (within 6 months for dependence; 2 for abuse)
- Taking any of the following exclusionary medications: antipsychotics, anticonvulsants, mood stabilizers, stimulants, antidepressant medications, medications with significant interactions with lurasidone, except during the washout prior to testing and blood collection
- Unstable medical condition, including significant liver disease, hypothyroidism (i.e., condition not adequately stabilized for 3 months), and conditions likely to require hospitalization or with a life expectancy of < 6 mos.*
- Patients considered at significant risk for suicide
- Inadequate understanding of English
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 |
|---|---|---|
| Lurasidone (Latuda)Also: LatudaAntipsychotic medication approved for use with Bipolar disorder | Drug | Lurasidone (Latuda) |
Primary outcome
Montgomery-Asberg Rating Scale for Depression (MADRS)
Time frame: Baseline
The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression. Nine of the items are based upon patient report, and one is on the rater's observation during the rating interview. MADRS items are rated on a 0-6 continuum (0=no abnormality, 6=severe).
Montgomery-Asberg Rating Scale for Depression (MADRS) at Week8
Time frame: Week 8
The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression. Nine of the items are based upon patient report, and one is on the rater's observation during the rating interview. MADRS items are rated on a 0-6 continuum (0=no abnormality, 6=severe).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35377567Lan MJ, Pantazatos SP, Ogden RT, Rubin-Falcone H, Hellerstein D, McGrath PJ, Mann JJ. Resting State MRI Amplitude of Low Frequency Fluctuations Associated With Suicidal Ideation in Bipolar Depression. J Clin Psychiatry. 2022 Mar 30;83(3):21m14054. doi: 10.4088/JCP.21m14054.
- Depression Evaluation Service (site location) websiteLink provided by the sponsor.
- Institutional department websiteLink provided by the sponsor.
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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.
Patrick J McGrath, MD principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lurasidone (Latuda) in people with Bipolar Depression, run by New York State Psychiatric Institute 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 6 inclusion and 22 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 12 Dec 2017. 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 13 Nov 2017). 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?
Montgomery-Asberg Rating Scale for Depression (MADRS) (time frame: Baseline). 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 NCT02239094, 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 12 Dec 2017.