<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/NCT04447807</url>
  </required_header>
  <id_info>
    <org_study_id>4040551</org_study_id>
    <secondary_id>3148742040000068</secondary_id>
    <nct_id>NCT04447807</nct_id>
  </id_info>
  <brief_title>Metacognitive Training With Bipolar Disorder Patients.</brief_title>
  <official_title>Rehabilitating Theory of Mind: A Randomized Control Study Using Metacognitive Training in a Group Format With Bipolar Disorder Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The guiding question of this project is to evaluate the effectiveness of MCT as a form of ToM&#xD;
      rehabilitation in patients diagnosed with BD who have deficits in this domain of social&#xD;
      cognition. To do this, the work aims to be divided into three stages: (i) Evaluation of&#xD;
      functionality through the FAST instrument (FAST score greater than or equal to 12 = mild&#xD;
      impairment), to determine a subgroup of patients with deficits in functionality and&#xD;
      evaluation scales for Montgomery &amp; Åsberg Depression Rating Scale (MADRS) and Young Mania&#xD;
      Rating Scale (YMRS) to verify euthymia, (ii) once these inclusion aspects have been verified,&#xD;
      a neuropsychological assessment of hot cognition variables will be carried out, (iii)&#xD;
      finally, the sample will be randomly divided into two groups, where one group will receive&#xD;
      structured MCT rehabilitation and the other will continue with standard pharmacological&#xD;
      treatment (TAU).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present study is justified by the importance of understanding, both theoretically and&#xD;
      practically, psychotherapeutic interventions aimed at rehabilitating social cognition (SC)&#xD;
      and specifically Theory of Mind (ToM) in individuals diagnosed with bipolar disorder (BD).&#xD;
      ToM is an essential component for social interaction and, therefore, impairment in this area&#xD;
      leads to problems related to interpersonal functioning. The majority of group rehabilitation&#xD;
      interventions proposed for BD have focused primarily on cold cognitive domains or, in some&#xD;
      cases, have only reserved one to two meetings to address strategies that integrate SC. BD is&#xD;
      a heterogeneous disorder in terms of sociocognitive impairments and, therefore, demands more&#xD;
      specific interventions for each individual (&quot;personalized medicine&quot;). Thus, the proposed&#xD;
      intervention corresponds to a specific focus on functional rehabilitation of social&#xD;
      cognition, with a focus on ToM, and has not yet been evaluated in this population through a&#xD;
      randomized controlled trial. Therefore, MCT intervention may be promising as a&#xD;
      psychotherapeutic intervention for patients who present deficits in ToM (evaluated through&#xD;
      their functionality).&#xD;
&#xD;
      Objectives General objective&#xD;
&#xD;
      To evaluate the effectiveness of MCT intervention through a randomized controlled trial in&#xD;
      euthymic patients diagnosed with BD, using Theory of Mind measures (using the RMET scale).&#xD;
&#xD;
      Specific objectives&#xD;
&#xD;
      To analyze the dynamics of changes between ToM and SC with the functionality scale (FAST). In&#xD;
      this way, it is better understood if: (i) as ToM improves, FAST also improves&#xD;
      (synchronicity)? And (ii) as SC improves, FAST also improves? (iii) Is there a correlation&#xD;
      between the change of the two before and after intervention?&#xD;
&#xD;
      To evaluate, analyze, and demonstrate, through neuropsychological assessment in a&#xD;
      descriptive-analytical study, qualitative and quantitative aspects of Social Cognition&#xD;
      processes in patients with BD.&#xD;
&#xD;
      Material and Methods&#xD;
&#xD;
      All participants will be recruited from patients regularly enrolled and clinically followed&#xD;
      up at the Bipolar Disorder Program - PROMAN - outpatient clinic at Hospital das Clínicas,&#xD;
      Faculty of Medicine, University of São Paulo. Participants will have access to the Informed&#xD;
      Consent Form (ICF) for this research, and only those who agree to participate will be&#xD;
      included in the study. This study aims to evaluate the efficacy of the MCT intervention with&#xD;
      a specific focus on ToM and CS. To this end, the methodological proposal is divided into two&#xD;
      stages: 01) Neuropsychological Evaluation of Cognition, ToM, and Social Cognition, and 02)&#xD;
      MCT Intervention versus TAU.&#xD;
&#xD;
      Randomization Individuals with Bipolar Disorder recruited for the research will be randomized&#xD;
      to the MCT arm or TP arm through the Pass 22 tool using a true random algorithm.&#xD;
&#xD;
      Procedures All patients who meet the described criteria and agree to participate in the study&#xD;
      by signing the research consent form will be evaluated using the proposed neuropsychological&#xD;
      battery. To proceed to the next stage of the project (intervention), only patients who have a&#xD;
      deficit (represented by a score of 12 or more points) on the functionality scale (Rosa et&#xD;
      al., 2007) will be randomly distributed (using the Pass 22 tool and a true random algorithm&#xD;
      by a third party blinded to the research) between the experimental (MCT) and control (TP)&#xD;
      groups. Twenty-six patients in the experimental group will participate in 9 weekly sessions&#xD;
      following the MCT intervention proposal developed for this study. This will be based on a&#xD;
      protocol recently developed for patients with TB by Haffner and colleagues (Haffner et al.,&#xD;
      2018) and adapted and translated by the author of this project, Luisa de Siqueira Rotenberg,&#xD;
      with authorization and approval for necessary modifications by the original authors. The&#xD;
      other twenty-six patients in the control group will receive standard treatment (TP). All&#xD;
      patients will also be accompanied by medical consultations at the Bipolar Disorder Program&#xD;
      outpatient clinic (PROMAN, IPq-HCFMUSP), which will be scheduled according to medical&#xD;
      evaluation. The amount of medication used and the number of medical consultations will not be&#xD;
      limited in this study, with the aim of increasing the generalization of possible results to&#xD;
      real clinical situations. However, these variables will be subsequently observed through&#xD;
      medical records produced during these consultations. The neuropsychological assessment&#xD;
      battery will be applied to all participants before the start of therapy groups and will be&#xD;
      reapplied after the end of the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 20, 2022</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients eligible for this study will be randomized into two groups: Metacognitive Training Intervention (9 weeks) or Treatment as Usual (9 weeks).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Theory of Mind</measure>
    <time_frame>9 weeks.</time_frame>
    <description>After the intervention, the group that received the MCT intervention will present changes from baseline Theory of Mind (ToM) scores at 9 weeks, when compared to TAU group. ToM Scores is evaluated by using Reading the Mind in the Eyes Test (RMET). Reading the Mind in the Eyes Test (RMET) is evaluated by each correct response is awarded 1 point, resulting in a minimum score of 0 and a maximum score of 28. Incomplete responses are treated as incorrect, domain scores are scaled in a positive direction (i.e. higher scores denote higher theory of mind).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functioning Outcome</measure>
    <time_frame>9 weeks</time_frame>
    <description>The functional assessment scale (FAST): FAST is a standardized rating scale that is used to assess the functional impairment of individuals with bipolar disorder. The scale is designed to assess the level of functional impairment across a range of domains including autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships, and leisure time. The FAST is typically administered as an interview-based assessment, with the interviewer asking questions about the individual's ability to perform specific tasks and activities in each of these domains.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Cognition</measure>
    <time_frame>9 weeks</time_frame>
    <description>Social cognition will be evaluated through the subtask of the CANTAB: Emotion Recognition Task.CANTAB Emotion Recognition Task is a computer-based cognitive assessment tool designed to measure an individual's ability to recognize emotions from facial expressions. The task presents a series of faces, each displaying a different emotional expression, and the participant is required to identify the emotion being displayed (such as happiness, sadness, anger, or fear) by selecting the appropriate label from a list of options.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">52</enrollment>
  <condition>Bipolar Disorder</condition>
  <arm_group>
    <arm_group_label>Group A: Metacognitive Training Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants of this group will undergo Metacognitive Training (MCT) in group format for the duration of 9 weeks. The intervention will be held once a week, with an estimated duration of 1-2 hours. The MCT intervention focuses on rehabilitating Social Cognition and teaching skills of interpersonal relations, as well as functional remediation aspects.&#xD;
We estimate a total of 26 participants in this group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B: Treatment as Usual</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants of this group will continue to receive medical attention in the Bipolar Disorder Program -PROMAN- part of the University of São Paulo Medical School, although they will not be part taking in any group rehabilitation format We estimate a total of 26 participants in this group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Metacognitive Training</intervention_name>
    <description>MCT is a structured, interactive approach that addresses cognitive biases, social cognition, and self-esteem. This study will conducted this intervention using group format, on a weekly basis, with duration of 9 weeks total.</description>
    <arm_group_label>Group A: Metacognitive Training Intervention</arm_group_label>
    <other_name>MCT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment as Usual</intervention_name>
    <description>Patients will continue to receive medical attention in the Bipolar Disorder Program -PROMAN- part of the University of São Paulo Medical School.</description>
    <arm_group_label>Group B: Treatment as Usual</arm_group_label>
    <other_name>TAU</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Diagnosis of Bipolar Disorder Type I and Type II following the DSM-V criteria, using&#xD;
             the Mini International Neuropsychiatric Interview (MINI) (Sheehan et al., 1998).&#xD;
&#xD;
          2. Adults between the ages of 18 and 60.&#xD;
&#xD;
          3. Both sexes.&#xD;
&#xD;
          4. FAST score greater than or equal to 12 (= mild impairment).&#xD;
&#xD;
          5. Education: Completed Elementary School, as a minimum educational criterion.&#xD;
&#xD;
          6. Estimated IQ ≥ 80.&#xD;
&#xD;
          7. Being in euthymia, assessed through scores lower than 8 on the Young Mania Rating&#xD;
             Scale (YMRS) and/or 12 on the Montgomery-Åsberg Depression Rating Scale (MADRS).&#xD;
&#xD;
          8. Agreement to participate in the study by signing the Informed Consent Form (TCLE).&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Subjects with complaints of visual or auditory sensory impairment that would not allow&#xD;
             for the administration of the tests.&#xD;
&#xD;
          2. Subjects with organic mental disorders.&#xD;
&#xD;
          3. Subjects with a history of alcohol or drug abuse in the last six months.&#xD;
&#xD;
          4. Treatment with electroconvulsive therapy in the last 12 months.&#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>Beny Lafer</last_name>
    <role>Study Director</role>
    <affiliation>Associate Professor of the Department of Psychiatry, USP</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Beny Lafer</last_name>
    <phone>551126617928</phone>
    <email>blafer@usp.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Luisa de Siqueira Rotenberg</last_name>
    <phone>551126617928</phone>
    <email>luisarotenberg@usp.br</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Institute of Psychiatry, Clinic Hospital University of São Paulo</name>
      <address>
        <city>São Paulo</city>
        <zip>05403-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luisa de Siqueira Rotenberg, PhD</last_name>
      <email>luisa.rotenberg@usp.br</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <results_reference>
    <citation>Haffner P, Quinlivan E, Fiebig J, Sondergeld LM, Strasser ES, Adli M, Moritz S, Stamm TJ. Improving functional outcome in bipolar disorder: A pilot study on metacognitive training. Clin Psychol Psychother. 2018 Jan;25(1):50-58. doi: 10.1002/cpp.2124. Epub 2017 Aug 30.</citation>
    <PMID>28857347</PMID>
  </results_reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>February 27, 2023</last_update_submitted>
  <last_update_submitted_qc>February 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Beny Lafer</investigator_full_name>
    <investigator_title>Associate Professor of the Department of Psychiatry (IPq), University of São Paulo Medical School</investigator_title>
  </responsible_party>
  <keyword>Bipolar Disorder</keyword>
  <keyword>Theory of Mind</keyword>
  <keyword>Social Cognition</keyword>
  <keyword>Metacognitive Training</keyword>
  <keyword>Cognitive Rehabilitation</keyword>
  <keyword>Cognitive Impairment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bipolar Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04447807
org study id: 4040551
secondary id: 3148742040000068
nct id: NCT04447807
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The guiding question of this project is to evaluate the effectiveness of MCT as a form of ToM
      rehabilitation in patients diagnosed with BD who have deficits in this domain of social
      cognition. To do this, the work aims to be divided into three stages: (i) Evaluation of
      functionality through the FAST instrument (FAST score greater than or equal to 12 = mild
      impairment), to determine a subgroup of patients with deficits in functionality and
      evaluation scales for Montgomery & Åsberg Depression Rating Scale (MADRS) and Young Mania
      Rating Scale (YMRS) to verify euthymia, (ii) once these inclusion aspects have been verified,
      a neuropsychological assessment of hot cognition variables will be carried out, (iii)
      finally, the sample will be randomly divided into two groups, where one group will receive
      structured MCT rehabilitation and the other will continue with standard pharmacological
      treatment (TAU).
The present study is justified by the importance of understanding, both theoretically and
      practically, psychotherapeutic interventions aimed at rehabilitating social cognition (SC)
      and specifically Theory of Mind (ToM) in individuals diagnosed with bipolar disorder (BD).
      ToM is an essential component for social interaction and, therefore, impairment in this area
      leads to problems related to interpersonal functioning. The majority of group rehabilitation
      interventions proposed for BD have focused primarily on cold cognitive domains or, in some
      cases, have only reserved one to two meetings to address strategies that integrate SC. BD is
      a heterogeneous disorder in terms of sociocognitive impairments and, therefore, demands more
      specific interventions for each individual ("personalized medicine"). Thus, the proposed
      intervention corresponds to a specific focus on functional rehabilitation of social
      cognition, with a focus on ToM, and has not yet been evaluated in this population through a
      randomized controlled trial. Therefore, MCT intervention may be promising as a
      psychotherapeutic intervention for patients who present deficits in ToM (evaluated through
      their functionality).

      Objectives General objective

      To evaluate the effectiveness of MCT intervention through a randomized controlled trial in
      euthymic patients diagnosed with BD, using Theory of Mind measures (using the RMET scale).

      Specific objectives

      To analyze the dynamics of changes between ToM and SC with the functionality scale (FAST). In
      this way, it is better understood if: (i) as ToM improves, FAST also improves
      (synchronicity)? And (ii) as SC improves, FAST also improves? (iii) Is there a correlation
      between the change of the two before and after intervention?

      To evaluate, analyze, and demonstrate, through neuropsychological assessment in a
      descriptive-analytical study, qualitative and quantitative aspects of Social Cognition
      processes in patients with BD.

      Material and Methods

      All participants will be recruited from patients regularly enrolled and clinically followed
      up at the Bipolar Disorder Program - PROMAN - outpatient clinic at Hospital das Clínicas,
      Faculty of Medicine, University of São Paulo. Participants will have access to the Informed
      Consent Form (ICF) for this research, and only those who agree to participate will be
      included in the study. This study aims to evaluate the efficacy of the MCT intervention with
      a specific focus on ToM and CS. To this end, the methodological proposal is divided into two
      stages: 01) Neuropsychological Evaluation of Cognition, ToM, and Social Cognition, and 02)
      MCT Intervention versus TAU.

      Randomization Individuals with Bipolar Disorder recruited for the research will be randomized
      to the MCT arm or TP arm through the Pass 22 tool using a true random algorithm.

      Procedures All patients who meet the described criteria and agree to participate in the study
      by signing the research consent form will be evaluated using the proposed neuropsychological
      battery. To proceed to the next stage of the project (intervention), only patients who have a
      deficit (represented by a score of 12 or more points) on the functionality scale (Rosa et
      al., 2007) will be randomly distributed (using the Pass 22 tool and a true random algorithm
      by a third party blinded to the research) between the experimental (MCT) and control (TP)
      groups. Twenty-six patients in the experimental group will participate in 9 weekly sessions
      following the MCT intervention proposal developed for this study. This will be based on a
      protocol recently developed for patients with TB by Haffner and colleagues (Haffner et al.,
      2018) and adapted and translated by the author of this project, Luisa de Siqueira Rotenberg,
      with authorization and approval for necessary modifications by the original authors. The
      other twenty-six patients in the control group will receive standard treatment (TP). All
      patients will also be accompanied by medical consultations at the Bipolar Disorder Program
      outpatient clinic (PROMAN, IPq-HCFMUSP), which will be scheduled according to medical
      evaluation. The amount of medication used and the number of medical consultations will not be
      limited in this study, with the aim of increasing the generalization of possible results to
      real clinical situations. However, these variables will be subsequently observed through
      medical records produced during these consultations. The neuropsychological assessment
      battery will be applied to all participants before the start of therapy groups and will be
      reapplied after the end of the intervention.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients eligible for this study will be randomized into two groups: Metacognitive Training Intervention (9 weeks) or Treatment as Usual (9 weeks).
primary purpose: Treatment
masking: Single (Investigator)
measure: Theory of Mind
time frame: 9 weeks.
description: After the intervention, the group that received the MCT intervention will present changes from baseline Theory of Mind (ToM) scores at 9 weeks, when compared to TAU group. ToM Scores is evaluated by using Reading the Mind in the Eyes Test (RMET). Reading the Mind in the Eyes Test (RMET) is evaluated by each correct response is awarded 1 point, resulting in a minimum score of 0 and a maximum score of 28. Incomplete responses are treated as incorrect, domain scores are scaled in a positive direction (i.e. higher scores denote higher theory of mind).
measure: Functioning Outcome
time frame: 9 weeks
description: The functional assessment scale (FAST): FAST is a standardized rating scale that is used to assess the functional impairment of individuals with bipolar disorder. The scale is designed to assess the level of functional impairment across a range of domains including autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships, and leisure time. The FAST is typically administered as an interview-based assessment, with the interviewer asking questions about the individual's ability to perform specific tasks and activities in each of these domains.
measure: Social Cognition
time frame: 9 weeks
description: Social cognition will be evaluated through the subtask of the CANTAB: Emotion Recognition Task.CANTAB Emotion Recognition Task is a computer-based cognitive assessment tool designed to measure an individual's ability to recognize emotions from facial expressions. The task presents a series of faces, each displaying a different emotional expression, and the participant is required to identify the emotion being displayed (such as happiness, sadness, anger, or fear) by selecting the appropriate label from a list of options.
arm group label: Group A: Metacognitive Training Intervention
arm group type: Experimental
description: Participants of this group will undergo Metacognitive Training (MCT) in group format for the duration of 9 weeks. The intervention will be held once a week, with an estimated duration of 1-2 hours. The MCT intervention focuses on rehabilitating Social Cognition and teaching skills of interpersonal relations, as well as functional remediation aspects.
We estimate a total of 26 participants in this group.
arm group label: Group B: Treatment as Usual
arm group type: Experimental
description: Participants of this group will continue to receive medical attention in the Bipolar Disorder Program -PROMAN- part of the University of São Paulo Medical School, although they will not be part taking in any group rehabilitation format We estimate a total of 26 participants in this group.
intervention type: Behavioral
intervention name: Metacognitive Training
description: MCT is a structured, interactive approach that addresses cognitive biases, social cognition, and self-esteem. This study will conducted this intervention using group format, on a weekly basis, with duration of 9 weeks total.
arm group label: Group A: Metacognitive Training Intervention
other name: MCT
intervention type: Other
intervention name: Treatment as Usual
description: Patients will continue to receive medical attention in the Bipolar Disorder Program -PROMAN- part of the University of São Paulo Medical School.
arm group label: Group B: Treatment as Usual
other name: TAU
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Beny Lafer
role: Study Director
affiliation: Associate Professor of the Department of Psychiatry, USP
last name: Beny Lafer
phone: 551126617928
email: blafer@usp.br
last name: Luisa de Siqueira Rotenberg
phone: 551126617928
email: luisarotenberg@usp.br
facility: 
status: Recruiting
contact: 
country: Brazil
citation: Haffner P, Quinlivan E, Fiebig J, Sondergeld LM, Strasser ES, Adli M, Moritz S, Stamm TJ. Improving functional outcome in bipolar disorder: A pilot study on metacognitive training. Clin Psychol Psychother. 2018 Jan;25(1):50-58. doi: 10.1002/cpp.2124. Epub 2017 Aug 30.
PMID: 28857347
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Beny Lafer
investigator title: Associate Professor of the Department of Psychiatry (IPq), University of São Paulo Medical School
mesh term: Bipolar Disorder
sharing ipd: No