Study of Efficacy of PEAR-004 in Schizophrenia

Novartis

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Device: Sham; Device: PEAR-004

Study type: Interventional

Funder types: Industry

Identifiers

NCT03751280

CPEA001A12201

Details and patient eligibility

About

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.

Full 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),

Enrollment: 112 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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112 participants in 2 patient groups

PEAR-004

Experimental group

Description:

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.

Treatment:

Device: PEAR-004

Sham

Sham Comparator group

Description:

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.

Treatment:

Device: Sham