<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/NCT03794076</url>
  </required_header>
  <id_info>
    <org_study_id>PRO18060112</org_study_id>
    <nct_id>NCT03794076</nct_id>
  </id_info>
  <brief_title>Cromoglicate Adjunctive Therapy for Outpatients With Schizophrenia</brief_title>
  <acronym>CATOS</acronym>
  <official_title>Cromoglicte Adjunctive Therapy for Outpatients With Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vishwajit Nimgaonkar, MD PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Stanley Medical Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a double blind adjunctive randomized controlled trial for schizophrenia using&#xD;
      cromoglicate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Schizophrenia (SZ) extracts a heavy personal and public health cost, primarily because there&#xD;
      is no effective treatment. Though many drugs are currently available, the majority provide&#xD;
      only partial relief for psychotic phenomena and none guarantee more than modest relief for&#xD;
      'negative symptoms' or for cognitive impairments. The Investigators must search for&#xD;
      additional effective and safe medications. Recently, big data analytic strategies have&#xD;
      yielded numerous 'repurposed' drugs, i.e., drugs with new indications that are already&#xD;
      licensed for other uses. These strategies utilize massive data bases of known drug effects to&#xD;
      find candidates that could predictably counteract known pathogenic effects of the disorder in&#xD;
      question. Repurposed drugs are appealing not only because they have already been marketed and&#xD;
      have known side effect profiles, but also because they have increased prior probability of&#xD;
      efficacy. Still, careful randomized controlled trials (RCTs) are necessary for the new&#xD;
      indications. The investigators have designed a systematic search for repurposed drugs likely&#xD;
      to be beneficial for patients with SZ. Our novel search strategy began with the construction&#xD;
      of a comprehensive protein-protein interaction network (PPI) for SZ using a validated method.&#xD;
      Next, The Investigators searched public data bases for drugs that have predicted effects on&#xD;
      multiple proteins in the SZ PPI network, but opposite to those observed in patients with SZ.&#xD;
      The initial list was pruned using predetermined criteria, leaving 7 drugs of which&#xD;
      cromoglycate (CGY) had the best negative correlation score. Reassuringly, three other drugs&#xD;
      with lower scores in our list have already been tested for SZ. CGY is a safe and highly&#xD;
      effective mast cell inhibitor that has been licensed for over 25 years for prophylaxis of&#xD;
      asthma and allergies; it is also used to treat systemic mastocytosis and ulcerative colitis.&#xD;
      Independent of our research, CGY is also predicted to stabilize the blood brain barrier&#xD;
      (BBB), which can be disrupted in patients with SZ. Animal studies and favorable Log P&#xD;
      estimates assure that CGY can cross the BBB. CGY has few reported side effects, despite its&#xD;
      extensive use. Thus, multiple factors motivate our RCT. The Investigators propose a double&#xD;
      blind adjunctive RCT for SZ using CGY. To maximize therapeutic benefits while minimizing risk&#xD;
      and discomfort, The Investigators will enroll outpatients with SZ who meet criteria for&#xD;
      residual positive symptoms after adequate trials of standard antipsychotic drug (APD) therapy&#xD;
      (N=100, total). The Investigators will prefer patients in the early course of their illness.&#xD;
      CGY or placebo will be added to prescribed medications for 4 weeks utilizing the Sequential&#xD;
      Parallel Comparison Design to maximize power. The primary outcome will be improvement in&#xD;
      positive symptoms as determined by the Positive and Negative Syndrome Scale (PANSS) positive&#xD;
      symptom subscale. Secondary outcomes include total symptoms (PANSS total score), negative&#xD;
      symptoms (PANSS negative symptom scale scores), cognition (Penn Computerized Neurocognitive&#xD;
      Battery), and social function. Serum CGY levels will be monitored. The Investigators have&#xD;
      proven experience with RCTs and the large number of patients are our clinical service ensures&#xD;
      that recruitment targets will be fulfilled.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
  <phase>Phase 1/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 will be a randomized placebo-controlled sequential parallel comparison design (SPCD).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Participant, care providers, Investigators and assessors will all be blinded. Study staff responsible for randomization will be unblinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in positive symptoms</measure>
    <time_frame>12 weeks</time_frame>
    <description>Clinical Severity as determined by the Positive and Negative Syndrome Scale (PANSS) positive symptom subscale. The PANSS is a standardized, clinical interview that rates the presence and severity of positive and negative symptoms, as well as general psychopathology for people with schizophrenia within the past week. Symptom severity for each item is rated according to which anchoring points in the 7-point scale (1 = absent; 7 = extreme) best describe the presentation of the symptom. 7 Items, (minimum score = 7, maximum score = 49)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total Symptoms</measure>
    <time_frame>12 weeks</time_frame>
    <description>Clinical Severity as determined by the Positive and Negative Syndrome Scale (PANSS) positive symptom subscale. The PANSS is a standardized, clinical interview that rates the presence and severity of positive and negative symptoms, as well as general psychopathology for people with schizophrenia within the past week. Symptom severity for each item is rated according to which anchoring points in the 7-point scale (1 = absent; 7 = extreme) best describe the presentation of the symptom. 30 Items, (minimum score = 7, maximum score = 210)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Negative Symptoms</measure>
    <time_frame>12 weeks</time_frame>
    <description>Clinical Severity as determined by the Positive and Negative Syndrome Scale (PANSS) positive symptom subscale. The PANSS is a standardized, clinical interview that rates the presence and severity of positive and negative symptoms, as well as general psychopathology for people with schizophrenia within the past week. Symptom severity for each item is rated according to which anchoring points in the 7-point scale (1 = absent; 7 = extreme) best describe the presentation of the symptom. 7 Items, (minimum score = 7, maximum score = 49)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognition</measure>
    <time_frame>12 weeks</time_frame>
    <description>As measured by the Penn Computerized Neurocognitive Battery (CNB)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sheehan's disability scale (SDS)</measure>
    <time_frame>12 Weeks</time_frame>
    <description>The SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life. Total score 0-30 (0 unimpaired, 30 highly impaired)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Assessment of Function (GAF)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The Global Assessment of Functioning, or GAF, scale is used to rate how serious a mental illness may be. It measures how much a person's symptoms affect his or her day-to-day life on a scale of 0 to 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Scale (QOL)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Self-administered questionnaire designed for use in patients with chronic illnesses. 7-point Likert-type scale ranging from &quot;delighted&quot; (7) to &quot;terrible&quot; (1). Total scale score (possible range: 16 - 112)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Total Positive and Negative Syndrome Scale (PANSS)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Clinical Severity as determined by the Positive and Negative Syndrome Scale (PANSS) positive symptom subscale. The PANSS is a standardized, clinical interview that rates the presence and severity of positive and negative symptoms, as well as general psychopathology for people with schizophrenia within the past week. Symptom severity for each item is rated according to which anchoring points in the 7-point scale (1 = absent; 7 = extreme) best describe the presentation of the symptom. 30 Items, (minimum score = 7, maximum score = 210)</description>
  </other_outcome>
  <other_outcome>
    <measure>Penn Computerized Neurocognitive Battery (CNB)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Developed in the Brain Behavior Lab at Penn, the CNB is a series of computerized tests that measure accuracy and speed of performance in major domains of cognition, including social-cognition. Battery measures the executive functions of abstraction and mental flexibility, attention, and working memory, episodic memory for words, faces and figures, intellectual functioning including verbal and nonverbal reasoning and spatial orientation, facial emotion processing and sensorimotor and motor speed. The participant completes this test on the computer with oversight by a research team member.</description>
  </other_outcome>
  <other_outcome>
    <measure>Sheehan's disability scale (SDS)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life. Total score 0-30 (0 unimpaired, 30 highly impaired)</description>
  </other_outcome>
  <other_outcome>
    <measure>Global Assessment of Function (GAF)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The Global Assessment of Functioning, or GAF, scale is used to rate how serious a mental illness may be. It measures how much a person's symptoms affect his or her day-to-day life on a scale of 0 to 100.</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of Life Scale (QOL)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Self-administered questionnaire designed for use in patients with chronic illnesses. 7-point Likert-type scale ranging from &quot;delighted&quot; (7) to &quot;terrible&quot; (1). Total scale score (possible range: 16 - 112)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Schizo Affective Disorder</condition>
  <arm_group>
    <arm_group_label>Cromoglycate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cromoglycate nasal spray</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline nasal spray</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cromoglycate</intervention_name>
    <description>Cromoglycate will be administered intranasally (nasal spray) (1 spray each nostril 4 times a day, 5.2 mg/spray</description>
    <arm_group_label>Cromoglycate</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>NasalCrom</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Normal saline nasal spray will be administered intranasally (nasal spray) (1 spray each nostril 4 times a day, 5.2 mg/spray)</description>
    <arm_group_label>Cromoglycate</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Saline Nasal Spray</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent.&#xD;
&#xD;
          -  Both genders, ages 18-60 years&#xD;
&#xD;
          -  Schizophrenia / schizoaffective disorder (DSM V).&#xD;
&#xD;
          -  Treated with the same APD for at least 60 days; Stable dose of APD for &gt; 1 month,&#xD;
             continued throughout the study.&#xD;
&#xD;
          -  PANSS total score of 60 and Score 4 or more on one or more items of the 'positive'&#xD;
             syndrome items (P1-P7)&#xD;
&#xD;
          -  Preference for patients with duration of psychosis less than 7 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No illicit substance use in last 30 days/no dependence in 6 months with the exception&#xD;
             of methadone treatment for opioid withdrawal.&#xD;
&#xD;
          -  History or current medical /neurological illnesses that may lead to an unstable course&#xD;
             with the exception of epilepsy which is well-controlled on an antiepileptic medication&#xD;
             for at least 6 months.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  History of immune disorders, HIV infection, or receiving immune-suppressants or&#xD;
             immuno-modulators, e.g., steroids.&#xD;
&#xD;
          -  Current or prior treatment with CGY or History of hypersensitivity to CGY.&#xD;
&#xD;
          -  Intellectual disability as defined in DSM V.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vishwajit L. Nimgaonkar, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vishwajit L Nimgaonkar, M.D., Ph.D.</last_name>
    <phone>(412) 246-6353</phone>
    <email>vishwajitNL@upmc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maribeth A Wesesky, BPS</last_name>
    <phone>(412) 310-3108</phone>
    <email>weseskyma@upmc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maribeth A Wesesky, BPS</last_name>
      <phone>412-310-3108</phone>
      <email>weseskyma@upmc.edu</email>
    </contact>
    <investigator>
      <last_name>Vinayak Sant, Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Satish Iyengar, Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Konasale Prasad, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maribeth A Wesesky, BPS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>January 4, 2023</last_update_submitted>
  <last_update_submitted_qc>January 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Vishwajit Nimgaonkar, MD PhD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>schizophrenia</keyword>
  <keyword>schizoaffective disorder</keyword>
  <keyword>cromoglicate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Mood Disorders</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cromolyn Sodium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No individual subject data will be shared.</ipd_description>
  </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/NCT03794076
org study id: PRO18060112
nct id: NCT03794076
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This is a double blind adjunctive randomized controlled trial for schizophrenia using
      cromoglicate.
Schizophrenia (SZ) extracts a heavy personal and public health cost, primarily because there
      is no effective treatment. Though many drugs are currently available, the majority provide
      only partial relief for psychotic phenomena and none guarantee more than modest relief for
      'negative symptoms' or for cognitive impairments. The Investigators must search for
      additional effective and safe medications. Recently, big data analytic strategies have
      yielded numerous 'repurposed' drugs, i.e., drugs with new indications that are already
      licensed for other uses. These strategies utilize massive data bases of known drug effects to
      find candidates that could predictably counteract known pathogenic effects of the disorder in
      question. Repurposed drugs are appealing not only because they have already been marketed and
      have known side effect profiles, but also because they have increased prior probability of
      efficacy. Still, careful randomized controlled trials (RCTs) are necessary for the new
      indications. The investigators have designed a systematic search for repurposed drugs likely
      to be beneficial for patients with SZ. Our novel search strategy began with the construction
      of a comprehensive protein-protein interaction network (PPI) for SZ using a validated method.
      Next, The Investigators searched public data bases for drugs that have predicted effects on
      multiple proteins in the SZ PPI network, but opposite to those observed in patients with SZ.
      The initial list was pruned using predetermined criteria, leaving 7 drugs of which
      cromoglycate (CGY) had the best negative correlation score. Reassuringly, three other drugs
      with lower scores in our list have already been tested for SZ. CGY is a safe and highly
      effective mast cell inhibitor that has been licensed for over 25 years for prophylaxis of
      asthma and allergies; it is also used to treat systemic mastocytosis and ulcerative colitis.
      Independent of our research, CGY is also predicted to stabilize the blood brain barrier
      (BBB), which can be disrupted in patients with SZ. Animal studies and favorable Log P
      estimates assure that CGY can cross the BBB. CGY has few reported side effects, despite its
      extensive use. Thus, multiple factors motivate our RCT. The Investigators propose a double
      blind adjunctive RCT for SZ using CGY. To maximize therapeutic benefits while minimizing risk
      and discomfort, The Investigators will enroll outpatients with SZ who meet criteria for
      residual positive symptoms after adequate trials of standard antipsychotic drug (APD) therapy
      (N=100, total). The Investigators will prefer patients in the early course of their illness.
      CGY or placebo will be added to prescribed medications for 4 weeks utilizing the Sequential
      Parallel Comparison Design to maximize power. The primary outcome will be improvement in
      positive symptoms as determined by the Positive and Negative Syndrome Scale (PANSS) positive
      symptom subscale. Secondary outcomes include total symptoms (PANSS total score), negative
      symptoms (PANSS negative symptom scale scores), cognition (Penn Computerized Neurocognitive
      Battery), and social function. Serum CGY levels will be monitored. The Investigators have
      proven experience with RCTs and the large number of patients are our clinical service ensures
      that recruitment targets will be fulfilled.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This study will be a randomized placebo-controlled sequential parallel comparison design (SPCD).
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Participant, care providers, Investigators and assessors will all be blinded. Study staff responsible for randomization will be unblinded.
measure: Improvement in positive symptoms
time frame: 12 weeks
description: Clinical Severity as determined by the Positive and Negative Syndrome Scale (PANSS) positive symptom subscale. The PANSS is a standardized, clinical interview that rates the presence and severity of positive and negative symptoms, as well as general psychopathology for people with schizophrenia within the past week. Symptom severity for each item is rated according to which anchoring points in the 7-point scale (1 = absent; 7 = extreme) best describe the presentation of the symptom. 7 Items, (minimum score = 7, maximum score = 49)
measure: Total Symptoms
time frame: 12 weeks
description: Clinical Severity as determined by the Positive and Negative Syndrome Scale (PANSS) positive symptom subscale. The PANSS is a standardized, clinical interview that rates the presence and severity of positive and negative symptoms, as well as general psychopathology for people with schizophrenia within the past week. Symptom severity for each item is rated according to which anchoring points in the 7-point scale (1 = absent; 7 = extreme) best describe the presentation of the symptom. 30 Items, (minimum score = 7, maximum score = 210)
measure: Negative Symptoms
time frame: 12 weeks
description: Clinical Severity as determined by the Positive and Negative Syndrome Scale (PANSS) positive symptom subscale. The PANSS is a standardized, clinical interview that rates the presence and severity of positive and negative symptoms, as well as general psychopathology for people with schizophrenia within the past week. Symptom severity for each item is rated according to which anchoring points in the 7-point scale (1 = absent; 7 = extreme) best describe the presentation of the symptom. 7 Items, (minimum score = 7, maximum score = 49)
measure: Cognition
time frame: 12 weeks
description: As measured by the Penn Computerized Neurocognitive Battery (CNB)
measure: Sheehan's disability scale (SDS)
time frame: 12 Weeks
description: The SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life. Total score 0-30 (0 unimpaired, 30 highly impaired)
measure: Global Assessment of Function (GAF)
time frame: 12 weeks
description: The Global Assessment of Functioning, or GAF, scale is used to rate how serious a mental illness may be. It measures how much a person's symptoms affect his or her day-to-day life on a scale of 0 to 100.
measure: Quality of Life Scale (QOL)
time frame: 12 weeks
description: Self-administered questionnaire designed for use in patients with chronic illnesses. 7-point Likert-type scale ranging from "delighted" (7) to "terrible" (1). Total scale score (possible range: 16 - 112)
measure: Total Positive and Negative Syndrome Scale (PANSS)
time frame: 12 weeks
description: Clinical Severity as determined by the Positive and Negative Syndrome Scale (PANSS) positive symptom subscale. The PANSS is a standardized, clinical interview that rates the presence and severity of positive and negative symptoms, as well as general psychopathology for people with schizophrenia within the past week. Symptom severity for each item is rated according to which anchoring points in the 7-point scale (1 = absent; 7 = extreme) best describe the presentation of the symptom. 30 Items, (minimum score = 7, maximum score = 210)
measure: Penn Computerized Neurocognitive Battery (CNB)
time frame: 12 weeks
description: Developed in the Brain Behavior Lab at Penn, the CNB is a series of computerized tests that measure accuracy and speed of performance in major domains of cognition, including social-cognition. Battery measures the executive functions of abstraction and mental flexibility, attention, and working memory, episodic memory for words, faces and figures, intellectual functioning including verbal and nonverbal reasoning and spatial orientation, facial emotion processing and sensorimotor and motor speed. The participant completes this test on the computer with oversight by a research team member.
measure: Sheehan's disability scale (SDS)
time frame: 12 weeks
description: The SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life. Total score 0-30 (0 unimpaired, 30 highly impaired)
measure: Global Assessment of Function (GAF)
time frame: 12 weeks
description: The Global Assessment of Functioning, or GAF, scale is used to rate how serious a mental illness may be. It measures how much a person's symptoms affect his or her day-to-day life on a scale of 0 to 100.
measure: Quality of Life Scale (QOL)
time frame: 12 weeks
description: Self-administered questionnaire designed for use in patients with chronic illnesses. 7-point Likert-type scale ranging from "delighted" (7) to "terrible" (1). Total scale score (possible range: 16 - 112)
arm group label: Cromoglycate
arm group type: Active Comparator
description: Cromoglycate nasal spray
arm group label: Placebo
arm group type: Placebo Comparator
description: Saline nasal spray
intervention type: Drug
intervention name: Cromoglycate
description: Cromoglycate will be administered intranasally (nasal spray) (1 spray each nostril 4 times a day, 5.2 mg/spray
arm group label: Cromoglycate
arm group label: Placebo
other name: NasalCrom
intervention type: Drug
intervention name: Placebo
description: Normal saline nasal spray will be administered intranasally (nasal spray) (1 spray each nostril 4 times a day, 5.2 mg/spray)
arm group label: Cromoglycate
arm group label: Placebo
other name: Saline Nasal Spray
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Vishwajit L. Nimgaonkar, M.D., Ph.D.
role: Principal Investigator
affiliation: University of Pittsburgh
last name: Vishwajit L Nimgaonkar, M.D., Ph.D.
phone: (412) 246-6353
email: vishwajitNL@upmc.edu
last name: Maribeth A Wesesky, BPS
phone: (412) 310-3108
email: weseskyma@upmc.edu
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Vishwajit Nimgaonkar, MD PhD
investigator title: Professor
mesh term: Schizophrenia
mesh term: Mood Disorders
mesh term: Psychotic Disorders
mesh term: Cromolyn Sodium
sharing ipd: No
ipd description: No individual subject data will be shared.