xml: <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/NCT05999240</url>
    </required_header>
    <id_info>
      <org_study_id>8449</org_study_id>
      <nct_id>NCT05999240</nct_id>
    </id_info>
    <brief_title>Pimavanserin for Rigid-compulsive Symptoms in Autism Spectrum Disorder</brief_title>
    <official_title>A Target Engagement Study of Pimavanserin for Behavioral Inflexibility With Open Label Trial for Rigid Rigid-compulsive Behavior in Adolescents and Adults With Autism</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>New York State Psychiatric Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>ACADIA Pharmaceuticals Inc.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Kansas Medical Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Research Foundation for Mental Hygiene, Inc.</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Weill Medical College of Cornell University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>New York State Psychiatric Institute</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This Phase 2 study examines the safety, tolerability, and preliminary efficacy of&#xD;
        pimavanserin in individuals with Autism Spectrum Disorder. Male or female participants aged&#xD;
        16 to 40 years of age will be randomized to receive single doses of either placebo or&#xD;
        pimavanserin in this randomized, placebo-controlled, cross-over designed study, followed by&#xD;
        open label extension.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The goal of this clinical trial is to learn the safety, tolerability and to assess&#xD;
        pimavanserin for effects on behavioral rigidity and rigid-compulsive behavior in adolescents&#xD;
        and adults with Autism Spectrum Disorder.&#xD;
  &#xD;
        Participants who meet protocol criteria will be randomly assigned to receive either&#xD;
        pimavanserin or placebo in a 1:1 ratio in the Treatment Period. After completing the second&#xD;
        experimental day of the cross-over trial, participants will immediately enter the Open-Label&#xD;
        Trial, where they will take pimavanserin 34 mg for six weeks total. There will be 2&#xD;
        recruiting sites with a total sample of 30 participants. Blinding will be maintained by using&#xD;
        identical tablets containing either Pimavanserin or placebo.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">December 15, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 15, 2025</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <intervention_model_description>This study plans to enroll 30 participants between the ages of 16-40 years old with a diagnosis of autism spectrum disorder to participate in a randomized, placebo-controlled, cross-over designed study. Participants will be randomized to take a single dose of either pimavanserin 34 mg or placebo (Visit 2) three hours before beginning a cognitive neuroscience battery. One week later (Visit 3), participants will take the other medication (placebo or pimavanserin 34 mg) three hours before beginning the cognitive neuroscience battery. After completing the second experimental day, participants will immediately enter the Open Label Trial, where they will take pimavanserin 34 mg for six weeks total, with study visits at 3 weeks (Visit 4) and 6 weeks (Visit 5) to complete safety and primary/secondary outcome measures, followed by a follow-up phone call within 30 days after completing the open label trial.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
      <masking_description>Information regarding Masking will be communicated to the investigational pharmacy only - all other staff will remain blind to group assignment throughout the study.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Evaluate the impact of a single dose of pimavanserin 34 mg versus placebo</measure>
      <time_frame>Post Intervention, 30 days after study completion</time_frame>
      <description>Assessed using cognitive neuroscience task, comparison between pimavanserin and placebo within participants in single-dose cross-over experiment.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Evaluate pimavanserin for treatment of restricted/repetitive behavior in ASD</measure>
      <time_frame>6 weeks of Open-Label treatment</time_frame>
      <description>Assessed using the Repetitive Behavior Scale - Revised (RBS-R) rated at baseline, 3, and 6 weeks.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Explore the effects of pimavanserin on an electroencephalogram event-related potential (EEG/ERP) reversal learning test</measure>
      <time_frame>Post 6-week treatment</time_frame>
      <description>Explore the effects of pimavanserin on an electroencephalogram event-related potential (EEG/ERP) learning task in the cross-over comparison (visits 2 and 3) and again at the end of 6 weeks of open label treatment.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Autism Spectrum Disorder</condition>
    <arm_group>
      <arm_group_label>Pimavanserin tartrate</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Pimavanserin 34 mg white to off-white capsules.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo to Pimavanserin tartrate</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Pimavanserin Tartrate 34 Mg ORAL CAPSULE [NUPLAZID]</intervention_name>
      <description>Participants will be randomized to take a single dose of either pimavanserin 34 mg or placebo at Visit 2.</description>
      <arm_group_label>Pimavanserin tartrate</arm_group_label>
      <other_name>Nuzplazid</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo for Pimavanserin Tartrate 34 Mg ORAL CAPSILE [NUPLAZID]</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participant must be at least 16 years old and no greater than 40 years old.&#xD;
  &#xD;
            -  Participants 18 years of age or older or a legally acceptable representative must be&#xD;
               able and willing to sign an informed consent document indicating understanding of the&#xD;
               protocol and procedures and willingness to participate in full. For adult&#xD;
               participants, a parent, caregiver, or other adult informant must also sign an informed&#xD;
               consent document indicating understanding the requirements for completing their&#xD;
               portion of the study and their willingness to participate. For a participant who is&#xD;
               under 18 years of age, a parent or guardian must sign an informed consent document&#xD;
               indicating understanding the protocol and procedures and willingness to participate in&#xD;
               full. Signed assent indicating understanding and willingness to participate is&#xD;
               required of participants under 18 years of age.&#xD;
  &#xD;
            -  Participant must have a diagnosis of Autism Spectrum Disorder, according to DSM-5&#xD;
               criteria, made by a licensed study psychiatrist or psychologist and supported by the&#xD;
               Autism Diagnostic Observation Schedule 2 (ADOS-2) completed at screening or within the&#xD;
               past 12 months prior to screening by an appropriately trained professional.&#xD;
  &#xD;
            -  Participant must have a Clinical Global Impression of Severity for Repetitive Behavior&#xD;
               of 4 or greater, as rated by the study psychiatrist or psychologist at Screening and&#xD;
               at Baseline&#xD;
  &#xD;
            -  Participant must have a non-verbal IQ of greater than or equal to 70 as determined by&#xD;
               the 4-subtest Wechsler Abbreviated Scale of Intelligence.&#xD;
  &#xD;
            -  Participant must be able to speak and understand English in order to complete study&#xD;
               measures.&#xD;
  &#xD;
            -  Participant must live with a parent, primary caregiver, or other adult informant who&#xD;
               can complete study measures on the basis of spending an average of at least 4 hours&#xD;
               per day with the participant&#xD;
  &#xD;
            -  Parent, primary caregiver, or other adult informant must speak and understand English&#xD;
               in order to complete study measures.&#xD;
  &#xD;
            -  Participant must be able to self-administer study medication or have parent/caregiver&#xD;
               be able to administer study medication.&#xD;
  &#xD;
            -  Participant must be able to swallow study medication whole with liquid.&#xD;
  &#xD;
            -  Participant or legally acceptable representative must be willing to continue current&#xD;
               medication(s) and behavioral intervention(s) and to not add or change medication(s) or&#xD;
               behavioral intervention(s) over the full course of the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participant is judged by the Investigator to be unable to perform or comply with all&#xD;
               study specific requirements.&#xD;
  &#xD;
            -  Participant is an employee of an investigator with direct involvement in the proposed&#xD;
               study or other studies under the direction of a study investigator, or is a family&#xD;
               member of an investigator.&#xD;
  &#xD;
            -  Participant has a history of any severe or unstable psychiatric condition (e.g.,&#xD;
               schizophrenia or other psychotic disorder, bipolar disorder, major depressive&#xD;
               disorder) that, in the opinion of the Investigator, could confound the interpretation&#xD;
               of the study results or put the participant at undue risk. An acute episode of a mood&#xD;
               disorder will be considered exclusionary; a participant with a history of mild to&#xD;
               moderate mood disorder may be included in the study under the discretion of the&#xD;
               Investigator. Other stable psychiatric conditions are permitted at the discretion of&#xD;
               the Investigator (e.g., attention deficit hyperactivity disorder, generalized anxiety&#xD;
               disorder, etc.).&#xD;
  &#xD;
            -  Participant has a current or recent history of clinically significant suicidal&#xD;
               ideation within the past 6 months, corresponding to a score of 3 or higher (active&#xD;
               suicidal ideation with some intent to act, without specific plan) on the Columbia&#xD;
               Suicide Severity Rating Scale (C-SSRS), or a history of suicidal behavior within the&#xD;
               past year, as validated by the C-SSRS at screening or Day 1.&#xD;
  &#xD;
            -  Participant has met DSM-5 criteria for a substance abuse disorder within the last 6&#xD;
               months prior to Screening, except for disorders related to caffeine or nicotine.&#xD;
  &#xD;
            -  Participant has a positive test for an illicit drug or cannabis at Screening or&#xD;
               Baseline. Participants who test positive for cannabis and who have a valid&#xD;
               prescription may be rescreened if they agree to abstain from the cannabis for the&#xD;
               length of their participation in the study. The repeat test must be negative for them&#xD;
               to participate in the study.&#xD;
  &#xD;
            -  Participant is taking a serotonin reuptake inhibitor or antipsychotic medication.&#xD;
  &#xD;
            -  Participant has had a change to psychotropic medications within the last 2 months&#xD;
  &#xD;
            -  Participant has received electroconvulsive therapy (ECT) in the last 6 months.&#xD;
  &#xD;
            -  Participant has received new-onset psychotherapy or has had a change in the intensity&#xD;
               of psychotherapy within the 2 months prior to Screening.&#xD;
  &#xD;
            -  Participant has known allergies, hypersensitivity, or intolerance to Pimavanserin or&#xD;
               its excipients.&#xD;
  &#xD;
            -  Participant has received an investigational drug or used an investigational medical&#xD;
               device within 3 months before the planned start of study or is currently enrolled in&#xD;
               an investigational study.&#xD;
  &#xD;
            -  Participant has a body mass index (BMI) &lt;17 or &gt;40 at Screening.&#xD;
  &#xD;
            -  Participant has a known history of long QT syndrome or family history of sudden death.&#xD;
  &#xD;
            -  Participant has a history of myocardial infarction, unstable angina, acute coronary&#xD;
               syndrome, or cerebrovascular accident (CVA) within the last 4 months. Has greater than&#xD;
               NYHA Class 2 congestive heart failure or Class 2 angina pectoris, sustained&#xD;
               ventricular tachycardia (VT), ventricular fibrillation, torsade de pointes, or syncope&#xD;
               due to an arrhythmia.&#xD;
  &#xD;
            -  Participant has a history of neuroleptic malignant syndrome/serotonin syndrome.&#xD;
  &#xD;
            -  Participant has had a seizure within the past 12 months. Individuals with seizure&#xD;
               disorders who are on stable seizure medications (i.e., without seizures in the past 12&#xD;
               months) are permitted at the discretion of the Investigator.&#xD;
  &#xD;
            -  Participant is pregnant or breast-feeding, or planning to become pregnant or&#xD;
               breastfeed while enrolled in this study or within 3 months after the last dose of&#xD;
               study drug.&#xD;
  &#xD;
            -  Participant has current evidence, or a history within the previous 3 months prior to&#xD;
               screening, of a serious and/or unstable neurologic, cardiovascular, respiratory,&#xD;
               gastrointestinal, renal, hepatic, hematologic, or other medical disorder, that, in the&#xD;
               opinion of the Investigator, would jeopardize the safe participation of the&#xD;
               Participant in the study.&#xD;
  &#xD;
            -  Participant has a history of malignancy within 5 years before screening (exceptions&#xD;
               are squamous and basal cell carcinomas of the skin and carcinoma in situ of the&#xD;
               cervix, or malignancy that in the opinion of the Investigator, is considered cured&#xD;
               with minimal risk of recurrence).&#xD;
  &#xD;
            -  Participant has a known history of a positive hepatitis C virus (HCV) or human&#xD;
               immunodeficiency virus (HIV) test.&#xD;
  &#xD;
            -  Participant has a Screening or Baseline ECG with a QTcF&gt;450ms when the QRS duration is&#xD;
               &lt;120 ms or has a Screening or Baseline ECG with a QTcF&gt;470 ms when the QRS duration is&#xD;
               &gt;120 ms.&#xD;
  &#xD;
            -  Participant has laboratory evidence of hypothyroidism at Screening, as measured by&#xD;
               thyroid stimulating hormone (TSH) and reflex free thyroxine (T4). If TSH is abnormal&#xD;
               and the reflex free T4 is normal, the Participant may be enrolled.&#xD;
  &#xD;
            -  Participant has current unstable diabetes or glycosylated hemoglobin (HbAIc) &gt;8% at&#xD;
               Screening.&#xD;
  &#xD;
            -  Participant has other clinically significant laboratory abnormalities that, in the&#xD;
               opinion of the Investigator, would jeopardize the safe participation of the study&#xD;
               Participant.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jeremy Veenstra-VanderWeele, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>New York State Psychiatric Institute</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Matthew Mosconi, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Kansas Center for Autism Research and Training</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alyssa Verdes, BA</last_name>
      <phone>914-997-5532</phone>
      <email>alyssa.verdes@nyspi.columbia.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Suvekcha Bhattachan, MA</last_name>
      <phone>914-997-5587</phone>
      <email>suvekcha.bhattachan@nyspi.columbia.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Wakarusa Research Facility</name>
        <address>
          <city>Lawrence</city>
          <state>Kansas</state>
          <zip>66049</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Abigail Driggers, B.S</last_name>
        <phone>785-864-4461</phone>
        <email>abigail.driggers@ku.edu</email>
      </contact>
      <contact_backup>
        <last_name>Maggie Cambell, M.T - B.C</last_name>
        <phone>(785)-864-4461</phone>
        <email>maggie.campbell@ku.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Matt Mosconi, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Ann Genovese, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Robin Shafer, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Kathryn Unruh, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Center for Autism and the Developing Brain</name>
        <address>
          <city>White Plains</city>
          <state>New York</state>
          <zip>10605</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Alyssa Verdes, B.A.</last_name>
        <phone>914-997-5532</phone>
        <email>alyssa.verdes@nyspi.columbia.edu</email>
      </contact>
      <contact_backup>
        <last_name>Suvekcha Bhattachan, M.A.</last_name>
        <phone>914-997-5587</phone>
        <email>suvekcha.bhattachan@nyspi.columbia.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Jeremy Veenstra-VanderWeele, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Pankhuree Vandana, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Karen Tang, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>New York State Psychiatric Institute</investigator_affiliation>
      <investigator_full_name>Jeremy Veenstra-vanderweele</investigator_full_name>
      <investigator_title>MD</investigator_title>
    </responsible_party>
    <keyword>Pimavanserin</keyword>
    <keyword>Nuplazid</keyword>
    <keyword>Antiparkinson Agents</keyword>
    <keyword>Antipsychotic Agents</keyword>
    <keyword>Serotonin 5-HT2 Receptor Antagont</keyword>
    <keyword>Physiological Effects of Drugs</keyword>
    <keyword>Serotonin Agents</keyword>
    <keyword>Autism Spectrum Disorder</keyword>
    <keyword>Autistic Disorder</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Autistic Disorder</mesh_term>
      <mesh_term>Autism Spectrum Disorder</mesh_term>
      <mesh_term>Child Development Disorders, Pervasive</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pimavanserin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05999240
  org study id: 8449
  nct id: NCT05999240
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  This Phase 2 study examines the safety, tolerability, and preliminary efficacy of
        pimavanserin in individuals with Autism Spectrum Disorder. Male or female participants aged
        16 to 40 years of age will be randomized to receive single doses of either placebo or
        pimavanserin in this randomized, placebo-controlled, cross-over designed study, followed by
        open label extension.
  The goal of this clinical trial is to learn the safety, tolerability and to assess
        pimavanserin for effects on behavioral rigidity and rigid-compulsive behavior in adolescents
        and adults with Autism Spectrum Disorder.
  
        Participants who meet protocol criteria will be randomly assigned to receive either
        pimavanserin or placebo in a 1:1 ratio in the Treatment Period. After completing the second
        experimental day of the cross-over trial, participants will immediately enter the Open-Label
        Trial, where they will take pimavanserin 34 mg for six weeks total. There will be 2
        recruiting sites with a total sample of 30 participants. Blinding will be maintained by using
        identical tablets containing either Pimavanserin or placebo.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: This study plans to enroll 30 participants between the ages of 16-40 years old with a diagnosis of autism spectrum disorder to participate in a randomized, placebo-controlled, cross-over designed study. Participants will be randomized to take a single dose of either pimavanserin 34 mg or placebo (Visit 2) three hours before beginning a cognitive neuroscience battery. One week later (Visit 3), participants will take the other medication (placebo or pimavanserin 34 mg) three hours before beginning the cognitive neuroscience battery. After completing the second experimental day, participants will immediately enter the Open Label Trial, where they will take pimavanserin 34 mg for six weeks total, with study visits at 3 weeks (Visit 4) and 6 weeks (Visit 5) to complete safety and primary/secondary outcome measures, followed by a follow-up phone call within 30 days after completing the open label trial.
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  masking description: Information regarding Masking will be communicated to the investigational pharmacy only - all other staff will remain blind to group assignment throughout the study.
  measure: Evaluate the impact of a single dose of pimavanserin 34 mg versus placebo
  time frame: Post Intervention, 30 days after study completion
  description: Assessed using cognitive neuroscience task, comparison between pimavanserin and placebo within participants in single-dose cross-over experiment.
  measure: Evaluate pimavanserin for treatment of restricted/repetitive behavior in ASD
  time frame: 6 weeks of Open-Label treatment
  description: Assessed using the Repetitive Behavior Scale - Revised (RBS-R) rated at baseline, 3, and 6 weeks.
  measure: Explore the effects of pimavanserin on an electroencephalogram event-related potential (EEG/ERP) reversal learning test
  time frame: Post 6-week treatment
  description: Explore the effects of pimavanserin on an electroencephalogram event-related potential (EEG/ERP) learning task in the cross-over comparison (visits 2 and 3) and again at the end of 6 weeks of open label treatment.
  arm group label: Pimavanserin tartrate
  arm group type: Experimental
  description: Pimavanserin 34 mg white to off-white capsules.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo to Pimavanserin tartrate
  intervention type: Drug
  intervention name: Pimavanserin Tartrate 34 Mg ORAL CAPSULE [NUPLAZID]
  description: Participants will be randomized to take a single dose of either pimavanserin 34 mg or placebo at Visit 2.
  arm group label: Pimavanserin tartrate
  other name: Nuzplazid
  intervention type: Drug
  intervention name: Placebo
  description: Placebo for Pimavanserin Tartrate 34 Mg ORAL CAPSILE [NUPLAZID]
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: Jeremy Veenstra-VanderWeele, MD
  role: Principal Investigator
  affiliation: New York State Psychiatric Institute
  last name: Matthew Mosconi, PhD
  role: Principal Investigator
  affiliation: University of Kansas Center for Autism Research and Training
  last name: Alyssa Verdes, BA
  phone: 914-997-5532
  email: alyssa.verdes@nyspi.columbia.edu
  last name: Suvekcha Bhattachan, MA
  phone: 914-997-5587
  email: suvekcha.bhattachan@nyspi.columbia.edu
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: New York State Psychiatric Institute
  investigator full name: Jeremy Veenstra-vanderweele
  investigator title: MD
  mesh term: Autistic Disorder
  mesh term: Autism Spectrum Disorder
  mesh term: Child Development Disorders, Pervasive
  mesh term: Pimavanserin
  sharing ipd: No