<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02239094</url>
  </required_header>
  <id_info>
    <org_study_id>#6954</org_study_id>
    <secondary_id>6954</secondary_id>
    <nct_id>NCT02239094</nct_id>
  </id_info>
  <brief_title>Biosignatures of Latuda for Bipolar Depression</brief_title>
  <official_title>Identification of Biosignatures for Lurasidone (Latuda) Response in Bipolar Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>New York State Psychiatric Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sumitomo Pharma America, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>New York State Psychiatric Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study proposes to conduct a pilot study of biological predictors of lurasidone response&#xD;
      in bipolar depression.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study proposes to enroll 20 participants with a bipolar disorder who are currently in an&#xD;
      episode of major depression.Magnetic resonance imaging (MRI), recordings of brain electrical&#xD;
      activity (EEG), and psychological testing to explore possible predictors of lurasidone&#xD;
      treatment response will be conducted. Blood samples will be collected for a future study of&#xD;
      blood protein predictors of response. After testing, participants will receive an open-label&#xD;
      8-week trial of lurasidone (Latuda™) at approved dosage levels. Participants who attain&#xD;
      remission of their major depressive episode will be eligible for a six-month continuation&#xD;
      phase to explore predictors of sustained response to continuation treatment. Data analyses&#xD;
      will use statistical testing to explore potential biological predictors of lurasidone&#xD;
      response. This will provide a framework for clarifying which patients are best suited to this&#xD;
      treatment and begin to develop a model for precision treatment of this difficult-to-treat&#xD;
      disorder.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Montgomery-Asberg Rating Scale for Depression (MADRS)</measure>
    <time_frame>Baseline</time_frame>
    <description>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.&#xD;
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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Montgomery-Asberg Rating Scale for Depression (MADRS) at Week8</measure>
    <time_frame>Week 8</time_frame>
    <description>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.&#xD;
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).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Bipolar Depression</condition>
  <arm_group>
    <arm_group_label>Lurasidone (Latuda)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All study participants will receive open-label Latuda.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lurasidone (Latuda)</intervention_name>
    <description>Antipsychotic medication approved for use with Bipolar disorder</description>
    <arm_group_label>Lurasidone (Latuda)</arm_group_label>
    <other_name>Latuda</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18- 60&#xD;
&#xD;
          2. Outpatients with a primary Diagnostic and Statistical Manual of the American&#xD;
             Psychiatric Association, Fourth Edition (DSM-IV) diagnosis of Bipolar Disorder I, II,&#xD;
             or NOS (Not Otherwise Specified)&#xD;
&#xD;
          3. Current episode of Major Depression&#xD;
&#xD;
          4. At least moderate severity of depression&#xD;
&#xD;
          5. Agrees to, and is eligible for, electroencephalogram (EEG) / psychological testing,&#xD;
             magnetic resonance imaging (MRI), and blood draws&#xD;
&#xD;
          6. Provides informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current drug or alcohol abuse/dependence, except nicotine (within 6 months for&#xD;
             dependence; 2 for abuse)&#xD;
&#xD;
          2. Taking any of the following exclusionary medications: antipsychotics, anticonvulsants,&#xD;
             mood stabilizers, stimulants, antidepressant medications, medications with significant&#xD;
             interactions with lurasidone, except during the washout prior to testing and blood&#xD;
             collection&#xD;
&#xD;
          3. Unstable medical condition, including significant liver disease, hypothyroidism (i.e.,&#xD;
             condition not adequately stabilized for 3 months), and conditions likely to require&#xD;
             hospitalization or with a life expectancy of &lt; 6 mos.*&#xD;
&#xD;
          4. Patients considered at significant risk for suicide&#xD;
&#xD;
          5. Inadequate understanding of English&#xD;
&#xD;
          6. Currently pregnant or breast-feeding; fecund women not using adequate contraceptive&#xD;
             methods; plan to become pregnant within 12 months&#xD;
&#xD;
          7. Contraindications to MRI (e.g. ferromagnetic body implants, history of metal working,&#xD;
             etc.)&#xD;
&#xD;
          8. Have epilepsy, neuromuscular disorder, or tardive dyskinesia&#xD;
&#xD;
          9. Require immediate hospitalization for psychiatric disorder&#xD;
&#xD;
         10. Require medications for a general medical condition that contraindicate any study&#xD;
             medication**&#xD;
&#xD;
         11. Receiving or have received during the index episode vagus nerve stimulation,&#xD;
             electroconvulsive therapy, transcranial magnetic stimulation, or other somatic&#xD;
             treatments&#xD;
&#xD;
         12. Allergy to, or other medical contraindication to lurasidone treatment&#xD;
&#xD;
         13. Currently enrolled in another research study, and participation in that study&#xD;
             contraindicates participation&#xD;
&#xD;
         14. Clinically significant screening laboratory abnormalities (* see below)&#xD;
&#xD;
         15. Currently taking an effective mood stabilizer and/or antidepressant regimen&#xD;
&#xD;
         16. Inability to undergo a three week medication-free period, including history of&#xD;
             significant clinical deterioration from past periods off medication or when medication&#xD;
             dosage was reduced, including mania, severe depression, etc.&#xD;
&#xD;
         17. Any reason not listed herein that would make participation in the study hazardous&#xD;
             *Medical criteria for exclusion:&#xD;
&#xD;
               -  Untreated hypertension: &gt; 140/90 Torr on repeated measurement (If hypertension&#xD;
                  becomes stabilized, subject may enroll in study)&#xD;
&#xD;
               -  Hepatitis: any liver function test &gt; 2x the upper limit of normal&#xD;
&#xD;
               -  Renal failure: estimated Glomerular Filtration Rate (eGFR, corrected for body&#xD;
                  surface area) repeatedly &lt; 30 mL/min&#xD;
&#xD;
               -  Hypothyroidism: thryrotropin stimulating hormone level &gt; upper limit of normal&#xD;
                  (unless accompanied by other euthyroid indices and the confirmation by an&#xD;
                  internist or endocrinologist that this does not represent hypothyroidism)&#xD;
&#xD;
               -  Anemia: hemoglobin &lt; 10 grams/deciliter (borderline hemoglobin must be of known&#xD;
                  origin, stable, and not clinically significant)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrick J McGrath, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York State Psychiatric Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York State Psychiatric Institute</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.depression-nyc.org</url>
    <description>Depression Evaluation Service (site location) website</description>
  </link>
  <link>
    <url>http://columbiapsychiatry.org/</url>
    <description>Institutional department website</description>
  </link>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <results_first_submitted>September 14, 2017</results_first_submitted>
  <results_first_submitted_qc>October 12, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">November 13, 2017</results_first_posted>
  <last_update_submitted>November 13, 2017</last_update_submitted>
  <last_update_submitted_qc>November 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bipolar Disorder</keyword>
  <keyword>depression</keyword>
  <keyword>Bipolar depression</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Bipolar Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lurasidone Hydrochloride</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Lurasidone (Latuda)</title>
          <description>All study participants will receive open-label Latuda.&#xD;
Lurasidone (Latuda): Antipsychotic medication approved for use with Bipolar disorder</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Remitted before started</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Lurasidone (Latuda)</title>
          <description>All study participants will receive open-label Latuda.&#xD;
Lurasidone (Latuda): Antipsychotic medication approved for use with Bipolar disorder</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="18"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.4" spread="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Montgomery-Asberg Rating Scale for Depression (MADRS)</title>
        <description>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.&#xD;
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).</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lurasidone (Latuda)</title>
            <description>All study participants will receive open-label Latuda.&#xD;
Lurasidone (Latuda): Antipsychotic medication approved for use with Bipolar disorder</description>
          </group>
        </group_list>
        <measure>
          <title>Montgomery-Asberg Rating Scale for Depression (MADRS)</title>
          <description>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.&#xD;
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).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.3" spread="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Montgomery-Asberg Rating Scale for Depression (MADRS) at Week8</title>
        <description>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.&#xD;
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).</description>
        <time_frame>Week 8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lurasidone (Latuda)</title>
            <description>All study participants will receive open-label Latuda.&#xD;
Lurasidone (Latuda): Antipsychotic medication approved for use with Bipolar disorder</description>
          </group>
        </group_list>
        <measure>
          <title>Montgomery-Asberg Rating Scale for Depression (MADRS) at Week8</title>
          <description>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.&#xD;
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).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" spread="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event was carefully monitored throughout the whole study period (8 Weeks)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Lurasidone (Latuda)</title>
          <description>All study participants will receive open-label Latuda.&#xD;
Lurasidone (Latuda): Antipsychotic medication approved for use with Bipolar disorder</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="2" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Weight Gain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>No healthy volunteer group and no placebo comparisons. And this is an open label treatment study.The results are also limited by the sample size.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>David J. Hellerstein</name_or_title>
      <organization>Depression Evaluation Service (New York State Psychiatric Institute)</organization>
      <phone>646-774-8069</phone>
      <email>david.hellerstein@nyspi.columbia.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02239094
org study id: #6954
secondary id: 6954
nct id: NCT02239094
lead sponsor: 
collaborator: 
has dmc: No
The study proposes to conduct a pilot study of biological predictors of lurasidone response
      in bipolar depression.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Montgomery-Asberg Rating Scale for Depression (MADRS)
time frame: Baseline
description: 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).
measure: Montgomery-Asberg Rating Scale for Depression (MADRS) at Week8
time frame: Week 8
description: 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).
arm group label: Lurasidone (Latuda)
arm group type: Other
description: All study participants will receive open-label Latuda.
intervention type: Drug
intervention name: Lurasidone (Latuda)
description: Antipsychotic medication approved for use with Bipolar disorder
arm group label: Lurasidone (Latuda)
other name: Latuda
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Patrick J McGrath, MD
role: Principal Investigator
affiliation: New York State Psychiatric Institute
facility: 
country: United States
url: http://www.depression-nyc.org
description: Depression Evaluation Service (site location) website
url: http://columbiapsychiatry.org/
description: Institutional department website
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Bipolar Disorder
mesh term: Lurasidone Hydrochloride
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: No healthy volunteer group and no placebo comparisons. And this is an open label treatment study.The results are also limited by the sample size.
point of contact: 