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Study of Efficacy of PEAR-004 in Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Device: PEAR-004
Device: Sham
Enrollment 112
Recruitment Details This study was conducted at 6 centers in the USA.
Pre-assignment Details The eligible subjects were randomized in 1:1 ratio to receive either PEAR-004 or sham.
Arm/Group Title PEAR-004 Sham
Hide Arm/Group Description Eligible participants were 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. Eligible participants were to access a sham control downloaded on a mobile device (iOS and Android based) as needed to delivering notifications prompting the participant to open the sham app, and then display a prescription timer for the remaining duration of app availability.
Period Title: Overall Study
Started [1] 56 56
Full Analysis Set (FAS) 54 55
Safety Set (SAF) 55 55
Completed 48 44
Not Completed 8 12
Reason Not Completed
Adverse Event             0             1
Lost to Follow-up             3             5
Physician Decision             0             2
Protocol Violation             0             2
Withdrawal by Subject             5             2
[1]
All enrolled participants were in Randomized Set
Arm/Group Title PEAR-004 Sham Total
Hide Arm/Group Description Eligible participants were 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. Eligible participants were to access a sham control downloaded on a mobile device (iOS and Android based) as needed to delivering notifications prompting the participant to open the sham app, and then display a prescription timer for the remaining duration of app availability. Total of all reporting groups
Overall Number of Baseline Participants 55 55 110
Hide Baseline Analysis Population Description
Safety Analysis Set = all randomized participants who received the study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants 55 participants 110 participants
43.7  (10.99) 45.7  (11.60) 44.7  (11.29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 55 participants 110 participants
Female
19
  34.5%
19
  34.5%
38
  34.5%
Male
36
  65.5%
36
  65.5%
72
  65.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 55 participants 55 participants 110 participants
American Indian or Alaska Native 3 0 3
Asian 3 4 7
Black or African American 28 25 53
Native Hawaiian or other Pacific Islander 0 1 1
White 18 25 43
Other 3 0 3
Disease duration at baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants 55 participants 110 participants
16.2  (11.40) 18.2  (11.56) 17.2  (11.47)
[1]
Measure Description: Disease Duration at baseline: Duration (in Years) from informed consent to date of diagnosis. Date of diagnosis corresponds to date where subjects reported schizophrenia diagnosis in medical history at screening visit.
Total Positive and Negative Syndrome Scale (PANSS) score at baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 55 participants 55 participants 110 participants
73.5  (10.25) 72.7  (10.10) 73.1  (10.14)
[1]
Measure Description: The Positive and Negative Syndrome Scale (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.
1.Primary Outcome
Title Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score
Hide Description 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.
Time Frame Baseline, Day 29, Day 57, Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title PEAR-004 Sham
Hide Arm/Group Description:
Eligible participants were 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.
Eligible participants were to access a sham control downloaded on a mobile device (iOS and Android based) as needed to delivering notifications prompting the participant to open the sham app, and then display a prescription timer for the remaining duration of app availability.
Overall Number of Participants Analyzed 54 55
Least Squares Mean (Standard Error)
Unit of Measure: Score
Day 29 Number Analyzed 52 participants 54 participants
-1.6  (0.86) -2.2  (0.84)
Day 57 Number Analyzed 49 participants 47 participants
-2.5  (0.9) -3.3  (0.9)
Day 85 Number Analyzed 48 participants 49 participants
-2.6  (1.14) -5.3  (1.13)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEAR-004, Sham
Comments Day 29
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Comparison of adjusted least square mean
Estimated Value 0.61
Confidence Interval (2-Sided) 90%
-1.4 to 2.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.200
Estimation Comments mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment * visit and baseline * visit interaction effects.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PEAR-004, Sham
Comments Day 57
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Comparison of adjusted least square mean
Estimated Value 0.80
Confidence Interval (2-Sided) 90%
-1.3 to 2.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.279
Estimation Comments mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment * visit and baseline * visit interaction effects.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PEAR-004, Sham
Comments Day 85
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0931
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Comparison of adjusted least square mean
Estimated Value 2.73
Confidence Interval (2-Sided) 90%
0.1 to 5.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.611
Estimation Comments mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment * visit and baseline * visit interaction effects.
2.Primary Outcome
Title Percent of Dropout
Hide Description Dropout rate to evaluate retention to assigned study treatment
Time Frame Day 115
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized Set
Arm/Group Title PEAR-004 Sham
Hide Arm/Group Description:
Eligible participants were 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.
Eligible participants were to access a sham control downloaded on a mobile device (iOS and Android based) as needed to delivering notifications prompting the participant to open the sham app, and then display a prescription timer for the remaining duration of app availability.
Overall Number of Participants Analyzed 56 56
Measure Type: Count of Participants
Unit of Measure: Participants
8
  14.3%
12
  21.4%
3.Secondary Outcome
Title Change From Baseline in the Positive PANSS Score
Hide Description 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.
Time Frame Baseline, Day 29, Day 57, Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title PEAR-004 Sham
Hide Arm/Group Description:
Eligible participants were 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.
Eligible participants were to access a sham control downloaded on a mobile device (iOS and Android based) as needed to delivering notifications prompting the participant to open the sham app, and then display a prescription timer for the remaining duration of app availability.
Overall Number of Participants Analyzed 54 55
Least Squares Mean (Standard Error)
Unit of Measure: Score
Day 29 Number Analyzed 52 participants 54 participants
-0.2  (0.36) -0.4  (0.35)
Day 57 Number Analyzed 49 participants 47 participants
-0.8  (0.38) -1.4  (0.38)
Day 85 Number Analyzed 48 participants 49 participants
-1.0  (0.46) -1.8  (0.45)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEAR-004, Sham
Comments Day 29
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Comparison of adjusted least square mean
Estimated Value 0.21
Confidence Interval (2-Sided) 90%
-0.6 to 1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.501
Estimation Comments mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment * visit and baseline * visit interaction effects.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PEAR-004, Sham
Comments Day 57
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Comparison of adjusted least square mean
Estimated Value 0.61
Confidence Interval (2-Sided) 90%
-0.3 to 1.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.538
Estimation Comments mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment * visit and baseline * visit interaction effects.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PEAR-004, Sham
Comments Day 85
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2069
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Comparison of adjusted least square mean
Estimated Value 0.82
Confidence Interval (2-Sided) 90%
-0.3 to 1.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.648
Estimation Comments mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment * visit and baseline * visit interaction effects.
4.Secondary Outcome
Title Change From Baseline in the General Psychopathology PANSS Score
Hide Description 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.
Time Frame Baseline, Day 29, Day 57, Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title PEAR-004 Sham
Hide Arm/Group Description:
Eligible participants were 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.
Eligible participants were to access a sham control downloaded on a mobile device (iOS and Android based) as needed to delivering notifications prompting the participant to open the sham app, and then display a prescription timer for the remaining duration of app availability.
Overall Number of Participants Analyzed 54 55
Least Squares Mean (Standard Error)
Unit of Measure: Score
Day 29 Number Analyzed 52 participants 54 participants
-0.8  (0.61) -1.4  (0.59)
Day 57 Number Analyzed 49 participants 47 participants
-1.4  (0.63) -1.5  (0.63)
Day 85 Number Analyzed 48 participants 49 participants
-1.2  (0.76) -2.8  (0.75)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEAR-004, Sham
Comments Day 29
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Comparison of adjusted least square mean
Estimated Value 0.51
Confidence Interval (2-Sided) 90%
-0.9 to 1.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.849
Estimation Comments mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment * visit and baseline * visit interaction effects.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PEAR-004, Sham
Comments Day 57
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Comparison of adjusted least square mean
Estimated Value 0.12
Confidence Interval (2-Sided) 90%
-1.4 to 1.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.890
Estimation Comments mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment * visit and baseline * visit interaction effects.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PEAR-004, Sham
Comments Day 85
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1368
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Comparison of adjusted least square mean
Estimated Value 1.61
Confidence Interval (2-Sided) 90%
-0.2 to 3.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.071
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in the Negative PANSS Score
Hide Description 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.
Time Frame Baseline, Day 29, Day 57, Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title PEAR-004 Sham
Hide Arm/Group Description:
Eligible participants were 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.
Eligible participants were to access a sham control downloaded on a mobile device (iOS and Android based) as needed to delivering notifications prompting the participant to open the sham app, and then display a prescription timer for the remaining duration of app availability.
Overall Number of Participants Analyzed 54 55
Least Squares Mean (Standard Error)
Unit of Measure: Score
Day 29 Number Analyzed 52 participants 54 participants
-0.5  (0.31) -0.4  (0.3)
Day 57 Number Analyzed 49 participants 47 participants
-0.3  (0.32) -0.5  (0.32)
Day 85 Number Analyzed 48 participants 49 participants
-0.4  (0.41) -0.9  (0.41)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEAR-004, Sham
Comments Day 29
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Comparison of adjusted least square mean
Estimated Value -0.13
Confidence Interval (2-Sided) 90%
-0.8 to 0.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.430
Estimation Comments mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment * visit and baseline * visit interaction effects.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PEAR-004, Sham
Comments Day 57
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Comparison of adjusted least square mean
Estimated Value 0.15
Confidence Interval (2-Sided) 90%
-0.6 to 0.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.453
Estimation Comments mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment * visit and baseline * visit interaction effects.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PEAR-004, Sham
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3798
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Comparison of adjusted least square mean
Estimated Value 0.51
Confidence Interval (2-Sided) 90%
-0.5 to 1.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.581
Estimation Comments mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment * visit and baseline * visit interaction effects.
6.Secondary Outcome
Title Change From Baseline in the Motivation and Pleasure Self-report (MAP-SR) Score
Hide Description 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.
Time Frame Baseline, Day 29, Day 57, Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title PEAR-004 Sham
Hide Arm/Group Description:
Eligible participants were 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.
Eligible participants were to access a sham control downloaded on a mobile device (iOS and Android based) as needed to delivering notifications prompting the participant to open the sham app, and then display a prescription timer for the remaining duration of app availability.
Overall Number of Participants Analyzed 54 55
Least Squares Mean (Standard Error)
Unit of Measure: Score
Day 29 Number Analyzed 51 participants 54 participants
0.8  (1.05) 1.6  (1.02)
Day 57 Number Analyzed 49 participants 47 participants
-0.5  (1.41) 1.1  (1.43)
Day 851.43 Number Analyzed 48 participants 49 participants
-1.2  (1.26) 2.8  (1.25)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEAR-004, Sham
Comments Day 29
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Comparison of adjusted least square mean
Estimated Value -0.79
Confidence Interval (2-Sided) 90%
-3.2 to 1.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: -0.79
Estimation Comments mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment * visit and baseline * visit interaction effects.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PEAR-004, Sham
Comments Day 57
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Comparison of adjusted least square mean
Estimated Value -1.60
Confidence Interval (2-Sided) 90%
-4.9 to 1.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.006
Estimation Comments mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment * visit and baseline * visit interaction effects.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PEAR-004, Sham
Comments Day 85
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0245
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Comparison of adjusted least square mean
Estimated Value -4.07
Confidence Interval (2-Sided) 90%
-7.0 to -1.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.780
Estimation Comments mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment * visit and baseline * visit interaction effects.
7.Secondary Outcome
Title Change From Baseline in the World Health Organization Quality of Life (WHOQOL-BREF) Scale
Hide Description 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).
Time Frame Baseline, Day 29, Day 57, Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title PEAR-004 Sham
Hide Arm/Group Description:
Eligible participants were 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.
Eligible participants were to access a sham control downloaded on a mobile device (iOS and Android based) as needed to delivering notifications prompting the participant to open the sham app, and then display a prescription timer for the remaining duration of app availability.
Overall Number of Participants Analyzed 54 55
Least Squares Mean (Standard Error)
Unit of Measure: Score
Day 29-Domain 1 Number Analyzed 52 participants 54 participants
-0.1  (0.37) 0.1  (0.36)
Day 57-Domain 1 Number Analyzed 49 participants 47 participants
-0.3  (0.44) -0.3  (0.45)
Day 85-Domain 1 Number Analyzed 48 participants 49 participants
0.2  (0.45) 0.1  (0.45)
Day 29-Domain 2 Number Analyzed 52 participants 54 participants
-0.6  (0.4) -0.1  (0.39)
Day 57-Domain 2 Number Analyzed 49 participants 47 participants
-0.7  (0.37) -0.6  (0.38)
Day 85-Domain 2 Number Analyzed 48 participants 49 participants
-0.5  (0.43) 0.1  (0.42)
Day 29-Domain 3 Number Analyzed 52 participants 54 participants
-0.3  (0.28) 0.1  (0.27)
Day 57-Domain 3 Number Analyzed 49 participants 47 participants
-0.3  (0.33) 0.1  (0.33)
Day 85-Domain 3 Number Analyzed 54 participants 55 participants
0.5  (0.33) 0.3  (0.33)
Day 29-Domain 4 Number Analyzed 52 participants 54 participants
-0.2  (0.61) -0.9  (0.6)
Day 57-Domain 4 Number Analyzed 49 participants 47 participants
-0.5  (0.61) -0.7  (0.61)
Day 85-Domain 4 Number Analyzed 54 participants 55 participants
-0.1  (0.69) 1.1  (0.68)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEAR-004, Sham
Comments Day 29-Domain 1
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Comparison of adjusted least square mean
Estimated Value -0.18
Confidence Interval (2-Sided) 90%
-1.0 to 0.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.516
Estimation Comments mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment * visit and baseline * visit interaction effects.
8.Secondary Outcome
Title Change From Baseline in the Beck Depression Inventory, Second Ed. (BDI-II) Total Score
Hide Description 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.
Time Frame Baseline, Day 29, Day 57, Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title PEAR-004 Sham
Hide Arm/Group Description:
Eligible participants were 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.
Eligible participants were to access a sham control downloaded on a mobile device (iOS and Android based) as needed to delivering notifications prompting the participant to open the sham app, and then display a prescription timer for the remaining duration of app availability.
Overall Number of Participants Analyzed 54 55
Least Squares Mean (Standard Error)
Unit of Measure: Score
Day 29 Number Analyzed 52 participants 54 participants
-1.0  (1.13) -0.1  (1.11)
Day 57 Number Analyzed 49 participants 47 participants
-4.8  (1.14) -1.5  (1.15)
Day 85 Number Analyzed 48 participants 49 participants
-3.4  (1.32) -3.2  (1.3)
9.Secondary Outcome
Title Percentage Change From Baseline in Total PANSS Score (Within Assigned Treatment Group)
Hide Description 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.
Time Frame Baseline, Day 29, Day 57, Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title PEAR-004 Sham
Hide Arm/Group Description:
Eligible participants were 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.
Eligible participants were to access a sham control downloaded on a mobile device (iOS and Android based) as needed to delivering notifications prompting the participant to open the sham app, and then display a prescription timer for the remaining duration of app availability.
Overall Number of Participants Analyzed 54 55
Least Squares Mean (Standard Error)
Unit of Measure: Score
Day 29 Number Analyzed 52 participants 54 participants
-2.0  (1.21) -3.0  (1.18)
Day 57 Number Analyzed 49 participants 47 participants
-3.6  (1.28) -4.4  (1.29)
Day 85 Number Analyzed 48 participants 49 participants
-3.7  (1.57) -7.1  (1.55)
10.Secondary Outcome
Title Percentage of Responders as Assessed by the Brief Medication Questionnaire (BMQ)
Hide Description The Brief Medication Questionnaire (BMQ) collects information about current schizophrenia medication use.
Time Frame Day 29, Day 57, and Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title PEAR-004 Sham
Hide Arm/Group Description:
Eligible participants were 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.
Eligible participants were to access a sham control downloaded on a mobile device (iOS and Android based) as needed to delivering notifications prompting the participant to open the sham app, and then display a prescription timer for the remaining duration of app availability.
Overall Number of Participants Analyzed 54 55
Measure Type: Count of Participants
Unit of Measure: Participants
Day 1
53
  98.1%
54
  98.2%
Day 29
52
  96.3%
53
  96.4%
Day 57
49
  90.7%
46
  83.6%
Day 85
48
  88.9%
48
  87.3%
Day 115 / End of Study
54
 100.0%
52
  94.5%
11.Secondary Outcome
Title Percentage of Responders as Assessed by the Total PANSS Score
Hide Description A Response is defined as a reduction of at least 20% at day 85 or last visit in total PANSS score relative to Baseline.
Time Frame Day 85
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Full Analysis Set (FAS)
Arm/Group Title PEAR-004 Sham
Hide Arm/Group Description:
Eligible participants were 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.
Eligible participants were to access a sham control downloaded on a mobile device (iOS and Android based) as needed to delivering notifications prompting the participant to open the sham app, and then display a prescription timer for the remaining duration of app availability.
Overall Number of Participants Analyzed 54 55
Measure Type: Count of Participants
Unit of Measure: Participants
2
   3.7%
9
  16.4%
12.Secondary Outcome
Title Number of Patients With Adverse Events
Hide Description Adverse events, serious adverse events, and adverse events leading to discontinuation throughout the study
Time Frame Day 115
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Hide Analysis Population Description
Safety Set (SAF)
Arm/Group Title PEAR-004 Sham
Hide Arm/Group Description:
Eligible participants were 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.
Eligible participants were to access a sham control downloaded on a mobile device (iOS and Android based) as needed to delivering notifications prompting the participant to open the sham app, and then display a prescription timer for the remaining duration of app availability.
Overall Number of Participants Analyzed 55 55
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with at least one AE
12
  21.8%
10
  18.2%
Study drug-related AEs
1
   1.8%
0
   0.0%
Participants with at least one SAE
0
   0.0%
1
   1.8%
AEs leading to discontinuation of study treatment
0
   0.0%
0
   0.0%
Study-drug related AEs leading to treatment disc.
0
   0.0%
0
   0.0%
13.Secondary Outcome
Title Number of Patients With Vital Sign Measurements
Hide Description Vital signs at baseline, day 85 or last visit
Time Frame Day 85
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title PEAR-004 Sham
Hide Arm/Group Description:
Eligible participants were 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.
Eligible participants were to access a sham control downloaded on a mobile device (iOS and Android based) as needed to delivering notifications prompting the participant to open the sham app, and then display a prescription timer for the remaining duration of app availability.
Overall Number of Participants Analyzed 55 55
Measure Type: Number
Unit of Measure: Number of participants
55 55
14.Secondary Outcome
Title InterSePT Scale for Suicidal Thinking-Plus (ISST-Plus) Score
Hide Description

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.

Time Frame Baseline, Day 29, 57, 85, and 115
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Hide Analysis Population Description
The number of subjects analyzed at different visits may differ from the overall number analyzed within a treatment group because some patients missed some visits.
Arm/Group Title PEAR-004 Sham
Hide Arm/Group Description:
Eligible participants were 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.
Eligible participants were to access a sham control downloaded on a mobile device (iOS and Android based) as needed to delivering notifications prompting the participant to open the sham app, and then display a prescription timer for the remaining duration of app availability.
Overall Number of Participants Analyzed 54 53
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Number Analyzed 52 participants 50 participants
0.0  (0.00) 0.1  (0.24)
Day 1 Number Analyzed 50 participants 52 participants
0.1  (0.31) 0.0  (0.14)
Day 29 Number Analyzed 51 participants 53 participants
0.0  (0.28) 0.1  (0.41)
Day 57 Number Analyzed 47 participants 46 participants
0.1  (0.44) 0.0  (0.00)
Day 85 Number Analyzed 48 participants 49 participants
0.1  (0.45) 0.1  (0.32)
Day 115 / End Of Study Number Analyzed 54 participants 53 participants
0.1  (0.43) 0.1  (0.45)
Time Frame Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 119 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PEAR-004 Sham Total
Hide Arm/Group Description Eligible participants were 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. Eligible participants were to access a sham control downloaded on a mobile device (iOS and Android based) as needed to delivering notifications prompting the participant to open the sham app, and then display a prescription timer for the remaining duration of app availability. Total
All-Cause Mortality
PEAR-004 Sham Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   0/55 (0.00%)   0/110 (0.00%) 
Hide Serious Adverse Events
PEAR-004 Sham Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   1/55 (1.82%)   1/110 (0.91%) 
Psychiatric disorders       
Suicidal ideation  1  0/55 (0.00%)  1/55 (1.82%)  1/110 (0.91%) 
1
Term from vocabulary, MedDRA (22.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PEAR-004 Sham Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   0/55 (0.00%)   0/110 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: Novartis.email@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT03751280    
Other Study ID Numbers: CPEA001A12201
First Submitted: November 8, 2018
First Posted: November 23, 2018
Results First Submitted: September 11, 2020
Results First Posted: November 23, 2020
Last Update Posted: January 5, 2021