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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 )

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.


Condition or disease Intervention/treatment Phase
Schizophrenia Device: PEAR-004 Device: Sham Phase 2

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),

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Sham-Controlled Study of PEAR-004 as an Adjunct to Standard-of-care Treatment for Schizophrenia
Actual Study Start Date : December 10, 2018
Actual Primary Completion Date : September 26, 2019
Actual Study Completion Date : September 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. 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.

  2. Percent of Dropout [ Time Frame: Day 115 ]
    Dropout rate to evaluate retention to assigned study treatment


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Number of Patients With Adverse Events [ Time Frame: Day 115 ]
    Adverse events, serious adverse events, and adverse events leading to discontinuation throughout the study

  11. Number of Patients With Vital Sign Measurements [ Time Frame: Day 85 ]
    Vital signs at baseline, day 85 or last visit

  12. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03751280


Locations
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United States, California
Novartis Investigative Site
Garden Grove, California, United States, 92845
Novartis Investigative Site
Oakland, California, United States, 94607
Novartis Investigative Site
Torrance, California, United States, 90502
United States, Florida
Novartis Investigative Site
Maitland, Florida, United States, 32751
United States, Michigan
Novartis Investigative Site
Grand Rapids, Michigan, United States, 49548
United States, New Mexico
Novartis Investigative Site
Albuquerque, New Mexico, United States, 87102
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Statistical Analysis Plan  [PDF] May 15, 2019
Study Protocol  [PDF] October 12, 2018

Additional Information:
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03751280    
Other Study ID Numbers: CPEA001A12201
First Posted: November 23, 2018    Key Record Dates
Results First Posted: November 23, 2020
Last Update Posted: January 5, 2021
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
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/

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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
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Schizophrenia
Digital Therapeutic
CBT
smartphone app
mental disorder
psychosis
acute psychotic reaction
chronic psychosis
failure to recognize what is real
false beliefs
unclear thinking,
confused thinking
auditory hallucinations
paranoia
reduced social engagement
reduced emotional expression
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders