Study of Efficacy of PEAR-004 in Schizophrenia

NCT03751280 | Completed Phase 2 Results FDA Device

• 1 other identifier: CPEA001A12201
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 6

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.

Conditions

Schizophrenia

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score

  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.

  Baseline, Day 29, Day 57, Day 85

• Percent of Dropout

  Dropout rate to evaluate retention to assigned study treatment

  Day 115

Secondary Outcomes (12)

• Change From Baseline in the Positive PANSS Score

  Baseline, Day 29, Day 57, Day 85

• Change From Baseline in the General Psychopathology PANSS Score

  Baseline, Day 29, Day 57, Day 85

• Change From Baseline in the Negative PANSS Score

  Baseline, Day 29, Day 57, Day 85

• Change From Baseline in the Motivation and Pleasure Self-report (MAP-SR) Score

  Baseline, Day 29, Day 57, Day 85

• Change From Baseline in the World Health Organization Quality of Life (WHOQOL-BREF) Scale

  Baseline, Day 29, Day 57, Day 85

Study Arms (2)

PEAR-004

EXPERIMENTAL

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

Sham

SHAM COMPARATOR

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

Interventions

PEAR-004 DEVICE

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.

PEAR-004

Sham DEVICE

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (6)

Novartis Investigative Site

Garden Grove, California, 92845, United States

Location

Novartis Investigative Site

Oakland, California, 94607, United States

Location

Novartis Investigative Site

Torrance, California, 90502, United States

Location

Novartis Investigative Site

Maitland, Florida, 32751, United States

Location

Novartis Investigative Site

Grand Rapids, Michigan, 49548, United States

Location

Novartis Investigative Site

Albuquerque, New Mexico, 87102, United States

Location

Related Publications (1)

• Ghaemi SN, Sverdlov O, van Dam J, Campellone T, Gerwien R. A Smartphone-Based Intervention as an Adjunct to Standard-of-Care Treatment for Schizophrenia: Randomized Controlled Trial. JMIR Form Res. 2022 Mar 28;6(3):e29154. doi: 10.2196/29154.

  PMID: 35343910 DERIVED

Related Links

• A Plain Language Trial Summary is available on novartisclinicatrials.com

MeSH Terms

Conditions

Schizophrenia; Mental Disorders; Psychotic Disorders; Hallucinations; Paranoid Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 23, 2018
• Study Start: December 10, 2018
• Primary Completion: September 26, 2019
• Study Completion: September 26, 2019
• Last Updated: January 5, 2021
• Results First Posted: November 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share

Locations

US (6)