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Study of Efficacy of PEAR-004 in Schizophrenia

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ClinicalTrials.gov Identifier: NCT03751280
Recruitment Status : Recruiting
First Posted : November 22, 2018
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:

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

The overall rationale for the study is 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 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 11, 2018
Estimated Primary Completion Date : October 11, 2019
Estimated Study Completion Date : October 11, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: PEAR-004
PEAR-004
Device: PEAR-004
PEAR-004

Sham Comparator: Sham
Sham
Device: Sham
Sham comparator




Primary Outcome Measures :
  1. 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

  2. Percent of dropout [ Time Frame: Day 115 ]
    Dropout rate


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

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

  6. Number of Patients with Vital signs [ Time Frame: Day 85 ]
    Vital signs at baseline, day 85 or last visit

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Other criteria may apply.


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


Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
United States, California
Novartis Investigative Site Recruiting
Garden Grove, California, United States, 92845
Novartis Investigative Site Recruiting
Oakland, California, United States, 94607
Novartis Investigative Site Recruiting
Torrance, California, United States, 90502
United States, Michigan
Novartis Investigative Site Recruiting
Grand Rapids, Michigan, United States, 49548
Sponsors and Collaborators
Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03751280     History of Changes
Other Study ID Numbers: CPEA001A12201
First Posted: November 22, 2018    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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


Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Schizophrenia
Digital Therapeutic
CBT
smartphone app

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders