Status:
COMPLETED
Study of Efficacy of PEAR-004 in Schizophrenia
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 Posi...
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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
December 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2019
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT03751280
Start Date
December 10 2018
End Date
September 26 2019
Last Update
January 5 2021
Active Locations (6)
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1
Novartis Investigative Site
Garden Grove, California, United States, 92845
2
Novartis Investigative Site
Oakland, California, United States, 94607
3
Novartis Investigative Site
Torrance, California, United States, 90502
4
Novartis Investigative Site
Maitland, Florida, United States, 32751