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Study of Efficacy of PEAR-004 in Schizophrenia

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ClinicalTrials.gov Identifier: NCT03751280
Recruitment Status : Completed
First Posted : November 23, 2018
Results First Posted : November 23, 2020
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE November 8, 2018
First Posted Date  ICMJE November 23, 2018
Results First Submitted Date  ICMJE September 11, 2020
Results First Posted Date  ICMJE November 23, 2020
Last Update Posted Date January 5, 2021
Actual Study Start Date  ICMJE December 10, 2018
Actual Primary Completion Date September 26, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2020)
  • Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score [ Time Frame: Baseline, Day 29, Day 57, Day 85 ]
    The Positive and Negative Syndrome Scale (PANSS) is a well validated, standardized method of evaluating and monitoring psychotic symptoms. The PANSS assesses: positive (hallucinations, delusions, thought disorder), negative (blunted affect, abstract thinking and general symptomatology. The positive and negative subscale each consist of 7 items rated from 1(absent) - 7(extreme) with a minimum score = 7, maximum score = 49. The general subscale consists of 16 items with a minimum score = 16, maximum score = 112. A Total PANSS score (positive+ negative + general scores) has a minimum of 30 and maximum of 210. Higher scores represent more severity in symptoms.
  • Percent of Dropout [ Time Frame: Day 115 ]
    Dropout rate to evaluate retention to assigned study treatment
Original Primary Outcome Measures  ICMJE
 (submitted: November 20, 2018)
  • Change in total Positive and Negative Syndrome Scale (PANSS) score [ Time Frame: Day 85 ]
    Total PANSS score from baseline to day 85 or last visit 30 different schizophrenia symptoms scored from 1-7 total score of 30-210 is sum of 7-item positive scale, 7-item negative scale, and 16-item general psychopathology scale higher values represent a worse outcome
  • Percent of Dropout [ Time Frame: Day 115 ]
    Dropout rate
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2020)
  • Change From Baseline in the Positive PANSS Score [ Time Frame: Baseline, Day 29, Day 57, Day 85 ]
    The PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale (eg, delusions, conceptual disorganization, hallucinatory behavior); 7 items that make up the Negative Scale (eg, blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); and 16 items that make up the General Psychopathology Scale (eg, somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, preoccupation). Individual items are scored with values ranging from 1 to 7. Total Negative and Positive Subscale scores each range from 7 to 49; higher score indicates greater severity.
  • Change From Baseline in the General Psychopathology PANSS Score [ Time Frame: Baseline, Day 29, Day 57, Day 85 ]
    The PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale (eg, delusions, conceptual disorganization, hallucinatory behavior); 7 items that make up the Negative Scale (eg, blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); and 16 items that make up the General Psychopathology Scale (eg, somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, preoccupation). Individual items are scored with values ranging from 1 to 7. Total General Psychopathology Subscale score range from 16 to 112; higher score indicates greater severity.
  • Change From Baseline in the Negative PANSS Score [ Time Frame: Baseline, Day 29, Day 57, Day 85 ]
    The PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale (eg, delusions, conceptual disorganization, hallucinatory behavior); 7 items that make up the Negative Scale (eg, blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); and 16 items that make up the General Psychopathology Scale (eg, somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, preoccupation). Individual items are scored with values ranging from 1 to 7. Total Negative and Positive Subscale scores each range from 7 to 49; higher score indicates greater severity.
  • Change From Baseline in the Motivation and Pleasure Self-report (MAP-SR) Score [ Time Frame: Baseline, Day 29, Day 57, Day 85 ]
    The MAP-SR is a 15-item self-report measure that provides a total score index of current motivation/pleasure negative symptoms. Responses are given on a 5-point scale where 0 = no pleasure or motivation and 4 = extreme pleasure or motivation. Total scores range from 0 to 60 and higher scores indicate greater motivation and pleasure during everyday activities.
  • Change From Baseline in the World Health Organization Quality of Life (WHOQOL-BREF) Scale [ Time Frame: Baseline, Day 29, Day 57, Day 85 ]
    The WHOQOL-BREF is a 26-item, self-report questionnaire and short version of WHOQOL-100, consisting of 4 domains: physical health (7 items) (Domain 1), psychological health (6 items) (Domian 2), social relationships (3 items) (Domain 3), and environmental health (8 items) (Domain 4); it also contains QOL and general health items. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score. Each individual item of the WHOQOL-BREF is scored from 1=not at all to 5=completely on a response scale, which is stipulated as a 5-point ordinal scale. The scores are then transformed linearly to a scale of 0 (the worse quality of life) to 100 (the worse quality of life).
  • Change From Baseline in the Beck Depression Inventory, Second Ed. (BDI-II) Total Score [ Time Frame: Baseline, Day 29, Day 57, Day 85 ]
    Beck Depression Inventory (BDI) is a 21-items self reported inventory with a scale evaluating depressive symptoms and the changes in BDI after treatment compared to baseline. The range of scores is 0 to 63, with higher scores indicating greater severity of depression.
  • Percentage Change From Baseline in Total PANSS Score (Within Assigned Treatment Group) [ Time Frame: Baseline, Day 29, Day 57, Day 85 ]
    The Positive and Negative Syndrome Scale (PANSS) is a well validated, standardized method of evaluating and monitoring psychotic symptoms. The PANSS assesses: positive (hallucinations, delusions, thought disorder), negative (blunted affect, abstract thinking and general symptomatology. The positive and negative subscale each consist of 7 items rated from 1(absent) - 7(extreme) with a minimum score = 7, maximum score = 49. The general subscale consists of 16 items with a minimum score = 16, maximum score = 112. A Total PANSS score (positive+ negative + general scores) has a minimum of 30 and maximum of 210. Higher scores represent more severity in symptoms.
  • Percentage of Responders as Assessed by the Brief Medication Questionnaire (BMQ) [ Time Frame: Day 29, Day 57, and Day 85 ]
    The Brief Medication Questionnaire (BMQ) collects information about current schizophrenia medication use.
  • Percentage of Responders as Assessed by the Total PANSS Score [ Time Frame: Day 85 ]
    A Response is defined as a reduction of at least 20% at day 85 or last visit in total PANSS score relative to Baseline.
  • Number of Patients With Adverse Events [ Time Frame: Day 115 ]
    Adverse events, serious adverse events, and adverse events leading to discontinuation throughout the study
  • Number of Patients With Vital Sign Measurements [ Time Frame: Day 85 ]
    Vital signs at baseline, day 85 or last visit
  • InterSePT Scale for Suicidal Thinking-Plus (ISST-Plus) Score [ Time Frame: Baseline, Day 29, 57, 85, and 115 ]
    InterSePT Scale for Suicidal Thinking-Plus (ISST-Plus) score. Semi-structured interview to assess severity of suicidal ideation and behavior Part I: collects information on 7 days prior to visit; 13 items scored 0 (min) to 2 (max) for suicidality, with a higher score representing a worse outcome Part II: collects information on suicidal behavior since last visit, with nominal categories Yes / No / Unknown (NA) Part III: global rating of status at time of interview; scored 0 (min) to 5 (max) for suicidality, with a higher score representing a worse outcome. Please note that only part III score (severity of suicidal risk) was summarized and reported.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2018)
  • Change in positive Positive and Negative Syndrome Scale (PANSS) score [ Time Frame: Day 29, 57, and 85 ]
    Change in the Positive PANSS score from baseline to day 29, day 57, and day 85 or last visit 7-item positive symptom scale, with score 1-7 on each item and a summed total range of 7-49 higher values represent a worse outcome
  • Change in the general psychopathology Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Day 29, 57, and 85 ]
    Change in the General Psychopathology PANSS score from baseline to day 29, day 57 and day 85 or last visit 16-item general psychopathology symptom scale, with score 1-7 on each item and a summed total range of 16-112 higher values represent a worse outcome
  • Change in the negative Positive and Negative Syndrome Scale (PANSS) score [ Time Frame: Day 29, 57, and 85 ]
    Change in the Negative PANSS score from baseline to day 29, day 57, and day 85 or last visit 7-item negative symptom scale, with score 1-7 on each item and a summed total range of 7-49 higher values represent a worse outcome
  • Change in the Motivation and Pleasure Self-report (MAP-SR) score [ Time Frame: Day 29, 57, and 85 ]
    Change in the Motivation and Pleasure self-report (MAP-SR) score from baseline to day 29, day 57, and day 85 or last visit Includes questions about social pleasure, recreational or work pleasure, close relationships, and motivation and effort to engage in activities 15 questions with a score of 0-4, summed for a total range of 0-60 higher values represent a better outcome
  • Number of Patients With Adverse Events [ Time Frame: Day 115 ]
    Adverse events, serious adverse events, and adverse events leading to discontinuation throughout the study
  • Number of Patients With Vital Signs [ Time Frame: Day 85 ]
    Vital signs at baseline, day 85 or last visit
  • InterSePT Scale for Suicidal Thinking-Plus (ISST-Plus) Score [ Time Frame: Baseline, Day 29, 57, 85, and 115 ]
    InterSePT Scale for Suicidal Thinking-Plus (ISST-Plus) score at baseline, day 29, day 57, day 85, and day 115 or last visit Semi-structured interview to assess severity of suicidal ideation and behavior Part I: collects information on 7 days prior to visit; 13 items scored 0, 1, or 2 Part II: collects information since last visit Part III: global rating of status at time of interview; scored 0-5 for suicidality, with a higher score representing a worse outcome
  • Change on the World Health Organization Quality of Life (WHOQOL-BREF) scale [ Time Frame: Day 29, 57, and 85 ]
    Change on the World Health Organization Quality of Life (WHOQOL-BREF) scale from baseline to day 29, day 57, and day 85 or last visit Includes questions about quality of life, health, or other areas of life 26 questions scored 1-5, for a raw score sum of 24-120 higher values represent a better outcome
  • Change in the Beck Depression Inventory, Second Ed. (BDI-II) total score [ Time Frame: Day 29, 57, and 85 ]
    Change in the Beck Depression Inventory, Second Edition (BDI-II) total score from baseline to day 29, day 57, and day 85 or last visit 21-item questionnaire with each item scored 0-3 for a summed total of 0-63 higher values represent a worse outcome
  • Percentage change in Positive and Negative Syndrome Scale (PANSS) score [ Time Frame: Day 29, 57, and 85 ]
    Percentage change in PANSS score (within assigned treatment group) from baseline to day 29, day 57, and day 85 or last visit 30 different schizophrenia symptoms scored from 1-7 total score of 30-210 is sum of 7-item positive scale, 7-item negative scale, and 16-item general psychopathology scale higher values represent a worse outcome
  • Number of Responders in total Positive and Negative Syndrome Scale (PANSS) score [ Time Frame: Day 85 ]
    Responders: defined as a reduction of at least 20% at day 85 or last visit in total PANSS score relative to baseline 30 different schizophrenia symptoms scored from 1-7 total score of 30-210 is sum of 7-item positive scale, 7-item negative scale, and 16-item general psychopathology scale higher values represent a worse outcome
  • Number of patients who responded to Brief Medication Questionnaire (BMQ) [ Time Frame: Day 29, 57, and 85 (last visit) ]
    Brief Medication Questionnaire (BMQ) collects information about current schizophrenia medication use
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Efficacy of PEAR-004 in Schizophrenia
Official Title  ICMJE A Randomized, Sham-Controlled Study of PEAR-004 as an Adjunct to Standard-of-care Treatment for Schizophrenia
Brief Summary

The purpose of the study was to determine in patients currently being administered antipsychotic pharmacotherapy whether PEAR-004 could further reduce symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS).

The overall rationale for the study was to assess the first prescription digital therapeutic (PDT) in schizophrenia using a form of proven psychosocial intervention, cognitive behavioral therapy (CBT), to supplement standard of care with antipsychotic medications.

Detailed Description

This was a randomized, sham-controlled, rater-blinded, parallel group trial. Overall, 112 subjects were randomized 1:1 in to the following groups:

  • Group A: Clinician-directed pharmacotherapy + PEAR-004
  • Group B: Clinician-directed pharmacotherapy + sham app An up to 28-day screening period included standard screening assessments as defined in the assessment schedule. Eligible subjects were randomized on Day 1 into one of the treatment groups.

Subjects in both groups continued to receive their clinician-directed standard-of-care treatment for schizophrenia, including pharmacotherapy. Subjects in Group A used PEAR 004 and subjects in Group B used a sham for a period of 12 weeks. Subjects returned to the clinic for outpatient visits at Week 4 (day 29), Week 8 (day 57), and Week 12 (day 85). At each visit, standard assessments were performed according to the assessment schedule, including PANSS, ISST-Plus, CGI, BMQ, MAP-SR, WHOQOL-BREF, BDI-II, ISI, and adverse events (AEs). A final follow-up visit was performed at Week 16 (day 115),

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Device: PEAR-004
    PEAR-004 (an investigational digital therapeutic) or sham (control) was downloaded to the subject's phone and then the assigned application was unlocked using a prescription code provided by Pear Therapeutics. As this was a digital therapeutic device study, dose or mode of administration is not applicable.
  • Device: Sham
    PEAR-004 (an investigational digital therapeutic) or sham (control) was downloaded to the subject's phone and then the assigned application was unlocked using a prescription code provided by Pear Therapeutics. As this was a digital therapeutic device study, dose or mode of administration is not applicable.
Study Arms  ICMJE
  • Experimental: PEAR-004
    Eligible participants were able to access PEAR-004 (an investigational digital therapeutic) on a mobile device (iOS and Android based) as needed to receive suggestions about coping strategies to overcome difficulties in daily life.
    Intervention: Device: PEAR-004
  • Sham Comparator: Sham
    Eligible participants were able to access a sham control downloaded on a mobile device (iOS and Android based) as needed to receive notifications prompting the participant to open the sham app, which displayed a prescription timer for the remaining duration of app availability.
    Intervention: Device: Sham
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 16, 2020)
112
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2018)
102
Actual Study Completion Date  ICMJE September 26, 2019
Actual Primary Completion Date September 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Signed informed consent must be obtained prior to participation in the study.
  • Healthy male and female subjects 18 to 65 years of age, inclusive, and in good health as determined by medical history, physical examination, and vital signs at screening
  • SCID-based DSM-5 diagnosis of schizophrenia and a total PANSS score > 60
  • Proficient in English at 5th grade reading level or higher, in the judgement of the investigator
  • Capable of using a mobile device (compatible with PEAR-004) and using common applications, in the judgement of the investigator

Key Exclusion Criteria:

  • Major change in primary antipsychotic medication in the prior 4 weeks before screening (e.g., switching to a new agent or a dose adjustment within two weeks of randomization)
  • Planning to move out of the geographic area within 3 months
  • Unable to use English to participate in the consent process, the interventions or assessments
  • Inability to comply with study procedures, due to severe medical conditions or otherwise
  • Meet DSM-5 diagnosis for a current episode of major depression, mania, or hypomania in the past month
  • Meet DSM-5 diagnosis for a current moderate or severe alcohol or cannabis use disorder in the past 2 months
  • Meet DSM-5 diagnosis for a current substance use disorder (other than alcohol or cannabis) in the past 2 months
  • Considered high risk for suicidal behavior based on ISST-Plus score at screening, or in the judgement of the investigator
  • Previously participated in a clinical study involving PEAR-004
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03751280
Other Study ID Numbers  ICMJE CPEA001A12201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

URL: https://www.clinicalstudydatarequest.com/
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP