Trial Outcomes & Findings for Trial to Evaluate the Effectiveness of a Digital Therapeutics in Adults Diagnosed With Major Depressive Disorder (NCT NCT04770285)
NCT ID: NCT04770285
Last Updated: 2024-10-16
Results Overview
The MADRS is used to assess depressive symptom severity. It consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts), each rated from 0 to 6 with zero being the "best" rating and 6 being the "worst" rating. The MADRS total score is the sum of ratings for all 10 items. The total score ranges from 0 to 60. A higher score on the MADRS represents a more severe level of depression. A negative change from baseline indicates improvement. Least square (LS) mean was estimated using Mixed Model Repeated Measures (MMRM) method.
COMPLETED
NA
386 participants
Baseline (Day 1) to Week 6
2024-10-16
Participant Flow
Participants were enrolled at 37 investigative sites in the United States from 25 February 2021 to 26 October 2022.
Participants with major depressive disorder were enrolled and randomized in a 1:1 ratio to 1 of the 2 digital mobile applications (CT-152 or sham) on Day 1.
Participant milestones
| Measure |
Digital Therapeutic A - CT-152
Participants received digital treatment session by using the CT-152 mobile application (app) from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of Emotional Faces Memory Task (EFMT) exercises and a psychotherapy lesson. From Week 7 up to Week 10 participants continued using the CT-152 app with optional psychotherapy lesson but did not receive any new EFMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed CT-152 treatment courses.
|
Digital Therapeutic B - Sham
Participants received digital treatment session by using a sham mobile app from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of a Shape and Memory Task (SMT) exercise only. From Week 7 up to Week 10 participants continued using the sham app but did not receive any new SMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed sham treatment courses.
|
|---|---|---|
|
Overall Study
STARTED
|
194
|
192
|
|
Overall Study
Full Analysis Set (FAS)
|
177
|
177
|
|
Overall Study
COMPLETED
|
165
|
164
|
|
Overall Study
NOT COMPLETED
|
29
|
28
|
Reasons for withdrawal
| Measure |
Digital Therapeutic A - CT-152
Participants received digital treatment session by using the CT-152 mobile application (app) from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of Emotional Faces Memory Task (EFMT) exercises and a psychotherapy lesson. From Week 7 up to Week 10 participants continued using the CT-152 app with optional psychotherapy lesson but did not receive any new EFMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed CT-152 treatment courses.
|
Digital Therapeutic B - Sham
Participants received digital treatment session by using a sham mobile app from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of a Shape and Memory Task (SMT) exercise only. From Week 7 up to Week 10 participants continued using the sham app but did not receive any new SMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed sham treatment courses.
|
|---|---|---|
|
Overall Study
Non-Compliance With Study Treatment
|
3
|
3
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
11
|
8
|
|
Overall Study
Protocol Deviation
|
6
|
6
|
|
Overall Study
Technical Problem
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
9
|
8
|
|
Overall Study
Reason Not Specified
|
0
|
1
|
Baseline Characteristics
Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Baseline characteristics by cohort
| Measure |
Digital Therapeutic A - CT-152
n=194 Participants
Participants received digital treatment session by using the CT-152 mobile app from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of EFMT exercises and a psychotherapy lesson. From Week 7 up to Week 10 participants continued using the CT-152 app with optional psychotherapy lesson but did not receive any new EFMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed CT-152 treatment courses.
|
Digital Therapeutic B - Sham
n=192 Participants
Participants received digital treatment session by using a sham mobile app from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of a SMT exercise only. From Week 7 up to Week 10 participants continued using the sham app but did not receive any new SMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed sham treatment courses.
|
Total
n=386 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.0 years
STANDARD_DEVIATION 12.1 • n=194 Participants
|
42.2 years
STANDARD_DEVIATION 12.1 • n=192 Participants
|
42.6 years
STANDARD_DEVIATION 12.1 • n=386 Participants
|
|
Sex: Female, Male
Female
|
165 Participants
n=194 Participants
|
167 Participants
n=192 Participants
|
332 Participants
n=386 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=194 Participants
|
25 Participants
n=192 Participants
|
54 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=194 Participants
|
16 Participants
n=192 Participants
|
36 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
173 Participants
n=194 Participants
|
174 Participants
n=192 Participants
|
347 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=194 Participants
|
2 Participants
n=192 Participants
|
3 Participants
n=386 Participants
|
|
Race/Ethnicity, Customized
White
|
141 Participants
n=194 Participants
|
160 Participants
n=192 Participants
|
301 Participants
n=386 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
36 Participants
n=194 Participants
|
25 Participants
n=192 Participants
|
61 Participants
n=386 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
5 Participants
n=194 Participants
|
1 Participants
n=192 Participants
|
6 Participants
n=386 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=194 Participants
|
4 Participants
n=192 Participants
|
9 Participants
n=386 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=194 Participants
|
2 Participants
n=192 Participants
|
9 Participants
n=386 Participants
|
|
MADRS Total Score
|
28.4 score on a scale
STANDARD_DEVIATION 6.0 • n=189 Participants • Number analyzed is the number of participants with data available for analysis at the specified timepoint.
|
28.4 score on a scale
STANDARD_DEVIATION 6.0 • n=186 Participants • Number analyzed is the number of participants with data available for analysis at the specified timepoint.
|
28.4 score on a scale
STANDARD_DEVIATION 6.0 • n=375 Participants • Number analyzed is the number of participants with data available for analysis at the specified timepoint.
|
|
Generalized Anxiety Disorder-7 (GAD-7) Total Score
|
9.5 score on a scale
STANDARD_DEVIATION 4.5 • n=185 Participants • Number analyzed is the number of participants with data available for analysis at the specified timepoint.
|
9.7 score on a scale
STANDARD_DEVIATION 4.8 • n=184 Participants • Number analyzed is the number of participants with data available for analysis at the specified timepoint.
|
9.6 score on a scale
STANDARD_DEVIATION 4.7 • n=369 Participants • Number analyzed is the number of participants with data available for analysis at the specified timepoint.
|
PRIMARY outcome
Timeframe: Baseline (Day 1) to Week 6Population: FAS included all randomized participants who received at least 1 occurrence of either CT-152 or sham use and had baseline and at least 1 postbaseline assessment of MADRS total score. Overall number of participants analyzed is the number of participants with data available for analysis.
The MADRS is used to assess depressive symptom severity. It consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts), each rated from 0 to 6 with zero being the "best" rating and 6 being the "worst" rating. The MADRS total score is the sum of ratings for all 10 items. The total score ranges from 0 to 60. A higher score on the MADRS represents a more severe level of depression. A negative change from baseline indicates improvement. Least square (LS) mean was estimated using Mixed Model Repeated Measures (MMRM) method.
Outcome measures
| Measure |
Digital Therapeutic A - CT-152
n=176 Participants
Participants received digital treatment session by using the CT-152 mobile app from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of EFMT exercises and a psychotherapy lesson. From Week 7 up to Week 10 participants continued using the CT-152 app with optional psychotherapy lesson but did not receive any new EFMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed CT-152 treatment courses.
|
Digital Therapeutic B - Sham
n=176 Participants
Participants received digital treatment session by using a sham mobile app from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of a SMT exercise only. From Week 7 up to Week 10 participants continued using the sham app but did not receive any new SMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed sham treatment courses.
|
|---|---|---|
|
Change From Baseline to Week 6 in the MADRS Total Score
|
-9.03 score on a scale
Standard Error 0.73
|
-7.25 score on a scale
Standard Error 0.73
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 6Population: FAS included all randomized participants who received at least 1 occurrence of either CT-152 or sham use and had baseline and at least 1 postbaseline assessment of MADRS total score. Overall number of participants analyzed is the number of participants with data available for analysis.
The GAD-7 is self-reported questionnaire designed to assess anxiety in participants. The scale contains 7 items (anxiety symptoms) and each item was rated by the participants from 0 (not at all) to 3 (nearly every day) based on how much they were bothered by each symptom. The total score ranges from 0 to 21. A higher score on the GAD-7 represents greater anxiety symptomatology. A negative change from baseline indicates improvement. LS mean was estimated using MMRM method.
Outcome measures
| Measure |
Digital Therapeutic A - CT-152
n=167 Participants
Participants received digital treatment session by using the CT-152 mobile app from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of EFMT exercises and a psychotherapy lesson. From Week 7 up to Week 10 participants continued using the CT-152 app with optional psychotherapy lesson but did not receive any new EFMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed CT-152 treatment courses.
|
Digital Therapeutic B - Sham
n=167 Participants
Participants received digital treatment session by using a sham mobile app from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of a SMT exercise only. From Week 7 up to Week 10 participants continued using the sham app but did not receive any new SMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed sham treatment courses.
|
|---|---|---|
|
Change From Baseline to Week 6 in the GAD-7 Total Score
|
-3.41 score on a scale
Standard Error 0.34
|
-2.64 score on a scale
Standard Error 0.34
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1) to Weeks 2 and 4Population: FAS included all randomized participants who received at least 1 occurrence of either CT-152 or sham use and had baseline and at least 1 postbaseline assessment of MADRS total score. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoints.
The MADRS is used to assess depressive symptom severity. It consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts), each rated from 0 to 6 with zero being the "best" rating and 6 being the "worst" rating. The MADRS total score is the sum of ratings for all 10 items. The total score ranges from 0 to 60. A higher score on the MADRS represents a more severe level of depression. A negative change from baseline indicates improvement. LS mean was estimated using MMRM method.
Outcome measures
| Measure |
Digital Therapeutic A - CT-152
n=176 Participants
Participants received digital treatment session by using the CT-152 mobile app from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of EFMT exercises and a psychotherapy lesson. From Week 7 up to Week 10 participants continued using the CT-152 app with optional psychotherapy lesson but did not receive any new EFMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed CT-152 treatment courses.
|
Digital Therapeutic B - Sham
n=176 Participants
Participants received digital treatment session by using a sham mobile app from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of a SMT exercise only. From Week 7 up to Week 10 participants continued using the sham app but did not receive any new SMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed sham treatment courses.
|
|---|---|---|
|
Change From Baseline to Weeks 2 and 4 in the MADRS Total Score
Week 2
|
-3.85 score on a scale
Standard Error 0.58
|
-3.23 score on a scale
Standard Error 0.59
|
|
Change From Baseline to Weeks 2 and 4 in the MADRS Total Score
Week 4
|
-6.62 score on a scale
Standard Error 0.67
|
-5.16 score on a scale
Standard Error 0.67
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1) to Weeks 2 and 4Population: FAS included all randomized participants who received at least 1 occurrence of either CT-152 or sham use and had baseline and at least 1 postbaseline assessment of MADRS total score. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoints.
The GAD-7 is self-reported questionnaire designed to assess anxiety in participants. The scale contains 7 items (anxiety symptoms) and each item was rated by the participants from 0 (not at all) to 3 (nearly every day) based on how much they were bothered by each symptom. The total score ranges from 0 to 21. A higher score on the GAD-7 represents greater anxiety symptomatology. A negative change from baseline indicates improvement. LS mean was estimated using MMRM method.
Outcome measures
| Measure |
Digital Therapeutic A - CT-152
n=167 Participants
Participants received digital treatment session by using the CT-152 mobile app from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of EFMT exercises and a psychotherapy lesson. From Week 7 up to Week 10 participants continued using the CT-152 app with optional psychotherapy lesson but did not receive any new EFMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed CT-152 treatment courses.
|
Digital Therapeutic B - Sham
n=167 Participants
Participants received digital treatment session by using a sham mobile app from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of a SMT exercise only. From Week 7 up to Week 10 participants continued using the sham app but did not receive any new SMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed sham treatment courses.
|
|---|---|---|
|
Change From Baseline to Weeks 2 and 4 in the GAD-7 Total Score
Week 2
|
-1.22 score on a scale
Standard Error 0.30
|
-0.88 score on a scale
Standard Error 0.30
|
|
Change From Baseline to Weeks 2 and 4 in the GAD-7 Total Score
Week 4
|
-2.22 score on a scale
Standard Error 0.33
|
-1.93 score on a scale
Standard Error 0.33
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1), Weeks 2, 4 and 6Population: FAS included all randomized participants who received at least 1 occurrence of either CT-152 or sham use and had baseline and at least 1 postbaseline assessment of MADRS total score. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoints.
The MADRS is used to assess depressive symptom severity. It consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts), each rated from 0 to 6 with zero being the "best" rating and 6 being the "worst" rating. The MADRS total score is the sum of ratings for all 10 items. The total score ranges from 0 to 60. A higher score on the MADRS represents a more severe level of depression. MADRS Response Rate was defined as the percentage of participants who achieved a reduction in the MADRS total score by 50% or more from baseline.
Outcome measures
| Measure |
Digital Therapeutic A - CT-152
n=176 Participants
Participants received digital treatment session by using the CT-152 mobile app from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of EFMT exercises and a psychotherapy lesson. From Week 7 up to Week 10 participants continued using the CT-152 app with optional psychotherapy lesson but did not receive any new EFMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed CT-152 treatment courses.
|
Digital Therapeutic B - Sham
n=176 Participants
Participants received digital treatment session by using a sham mobile app from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of a SMT exercise only. From Week 7 up to Week 10 participants continued using the sham app but did not receive any new SMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed sham treatment courses.
|
|---|---|---|
|
MADRS Response Rate at Weeks 2, 4, and 6
Week 2
|
10.86 percentage of participants
|
5.85 percentage of participants
|
|
MADRS Response Rate at Weeks 2, 4, and 6
Week 4
|
18.18 percentage of participants
|
13.64 percentage of participants
|
|
MADRS Response Rate at Weeks 2, 4, and 6
Week 6
|
28.41 percentage of participants
|
20.45 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1) to Weeks 2, 4 and 6Population: FAS included all randomized participants who received at least 1 occurrence of either CT-152 or sham use and had baseline and at least 1 postbaseline assessment of MADRS total score. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoints.
The CGI-S is a standardized, clinician-administered global rating scale that measures disease severity on a 7-point Likert scale To perform this assessment, the investigator (or designee) answered the following question: "Considering your total clinical experience with this particular population, how mentally ill (as related to agitation) is the participant at this time?" Response choices are 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill subjects. The score 0 (not assessed) will be set to missing. LS mean was estimated using MMRM method.
Outcome measures
| Measure |
Digital Therapeutic A - CT-152
n=175 Participants
Participants received digital treatment session by using the CT-152 mobile app from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of EFMT exercises and a psychotherapy lesson. From Week 7 up to Week 10 participants continued using the CT-152 app with optional psychotherapy lesson but did not receive any new EFMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed CT-152 treatment courses.
|
Digital Therapeutic B - Sham
n=172 Participants
Participants received digital treatment session by using a sham mobile app from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of a SMT exercise only. From Week 7 up to Week 10 participants continued using the sham app but did not receive any new SMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed sham treatment courses.
|
|---|---|---|
|
Change From Baseline to Weeks 2, 4 and 6 in the Clinical Global Impression - Severity of Illness (CGI-S) Score
Week 2
|
-0.54 score on a scale
Standard Error 0.06
|
-0.34 score on a scale
Standard Error 0.06
|
|
Change From Baseline to Weeks 2, 4 and 6 in the Clinical Global Impression - Severity of Illness (CGI-S) Score
Week 4
|
-0.84 score on a scale
Standard Error 0.07
|
-0.52 score on a scale
Standard Error 0.07
|
|
Change From Baseline to Weeks 2, 4 and 6 in the Clinical Global Impression - Severity of Illness (CGI-S) Score
Week 6
|
-1.06 score on a scale
Standard Error 0.08
|
-0.80 score on a scale
Standard Error 0.08
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1) to Week 6Population: FAS included all randomized participants who received at least 1 occurrence of either CT-152 or sham use and had baseline and at least 1 postbaseline assessment of MADRS total score. Overall number of participants analyzed is the number of participants with data available for analysis.
The WHODAS 2.0 is a 36-item self-assessment scale to measure a participant's function and disability across 6 domains of life: cognition (understanding \& communicating), mobility (moving \& getting around), self-care (hygiene, dressing, eating, staying alone), getting along (interacting with others), life activities (domestic responsibilities, leisure, work \& school), \& participation (community \& society). Each item is rated from 0 (none) to 4 (extreme or cannot do). The total score of the 36 items is converted into a metric ranging from 0 (no-disability) to 100 (full- disability) by dividing the total score by the maximum possible value of the total score, which is 144 for 36 items and multiplying by 100. LS Mean was estimated using ANCOVA method.
Outcome measures
| Measure |
Digital Therapeutic A - CT-152
n=157 Participants
Participants received digital treatment session by using the CT-152 mobile app from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of EFMT exercises and a psychotherapy lesson. From Week 7 up to Week 10 participants continued using the CT-152 app with optional psychotherapy lesson but did not receive any new EFMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed CT-152 treatment courses.
|
Digital Therapeutic B - Sham
n=155 Participants
Participants received digital treatment session by using a sham mobile app from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of a SMT exercise only. From Week 7 up to Week 10 participants continued using the sham app but did not receive any new SMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed sham treatment courses.
|
|---|---|---|
|
Change From Baseline to Week 6 in the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Total Score
|
-5.58 score on a scale
Standard Error 1.15
|
-4.56 score on a scale
Standard Error 1.18
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening to Weeks 4 and 6Population: FAS included all randomized participants who received at least 1 occurrence of either CT-152 or sham use and had baseline and at least 1 postbaseline assessment of MADRS total score. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoints.
The PHQ-9 is a standardized, self-administered rating scale that assesses the severity of depressive symptoms. The scale consists of 9 items, representing the 9 criteria upon which the diagnosis of DSM-IV depressive disorders is based. Each item is rated from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27. A higher score on the PHQ-9 represents a higher severity of depressive symptoms. LS mean was estimated using MMRM method.
Outcome measures
| Measure |
Digital Therapeutic A - CT-152
n=160 Participants
Participants received digital treatment session by using the CT-152 mobile app from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of EFMT exercises and a psychotherapy lesson. From Week 7 up to Week 10 participants continued using the CT-152 app with optional psychotherapy lesson but did not receive any new EFMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed CT-152 treatment courses.
|
Digital Therapeutic B - Sham
n=157 Participants
Participants received digital treatment session by using a sham mobile app from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of a SMT exercise only. From Week 7 up to Week 10 participants continued using the sham app but did not receive any new SMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed sham treatment courses.
|
|---|---|---|
|
Change From Screening to Weeks 4 and 6 in the PHQ-9 Total Score.
Week 4
|
-5.14 score on a scale
Standard Error 0.43
|
-3.85 score on a scale
Standard Error 0.45
|
|
Change From Screening to Weeks 4 and 6 in the PHQ-9 Total Score.
Week 6
|
-6.68 score on a scale
Standard Error 0.45
|
-5.10 score on a scale
Standard Error 0.46
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1), Weeks 2, 4 and 6Population: FAS included all randomized participants who received at least 1 occurrence of either CT-152 or sham use and had baseline and at least 1 postbaseline assessment of MADRS total score. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoints.
The MADRS is used to assess depressive symptom severity. It consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts), each rated from 0 to 6 with zero being the "best" rating and 6 being the "worst" rating. The MADRS total score is the sum of ratings for all 10 items. The total score ranges from 0 to 60. A higher score on the MADRS represents a more severe level of depression. MADRS partial response was defined as the percentage of participants who achieved a reduction in the MADRS total score by 30% or more and less than 50% from baseline.
Outcome measures
| Measure |
Digital Therapeutic A - CT-152
n=176 Participants
Participants received digital treatment session by using the CT-152 mobile app from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of EFMT exercises and a psychotherapy lesson. From Week 7 up to Week 10 participants continued using the CT-152 app with optional psychotherapy lesson but did not receive any new EFMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed CT-152 treatment courses.
|
Digital Therapeutic B - Sham
n=176 Participants
Participants received digital treatment session by using a sham mobile app from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of a SMT exercise only. From Week 7 up to Week 10 participants continued using the sham app but did not receive any new SMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed sham treatment courses.
|
|---|---|---|
|
MADRS Partial Response at Weeks 2, 4 and 6
Week 2
|
13.14 percentage of participants
|
11.11 percentage of participants
|
|
MADRS Partial Response at Weeks 2, 4 and 6
Week 4
|
19.32 percentage of participants
|
16.48 percentage of participants
|
|
MADRS Partial Response at Weeks 2, 4 and 6
Week 6
|
19.89 percentage of participants
|
17.05 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1), Weeks 8 and 10Population: FAS included all randomized participants who received at least 1 occurrence of either CT-152 or sham use and had baseline and at least 1 postbaseline assessment of MADRS total score. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoints.
The MADRS is used to assess depressive symptom severity. It consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts), each rated from 0 to 6 with zero being the "best" rating and 6 being the "worst" rating. The MADRS total score is the sum of ratings for all 10 items. The total score ranges from 0 to 60. A higher score on the MADRS represents a more severe level of depression. MADRS Response Rate (full or partial) was defined as the percentage of participants who achieved a reduction in the MADRS total score by 30% or more from baseline.
Outcome measures
| Measure |
Digital Therapeutic A - CT-152
n=168 Participants
Participants received digital treatment session by using the CT-152 mobile app from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of EFMT exercises and a psychotherapy lesson. From Week 7 up to Week 10 participants continued using the CT-152 app with optional psychotherapy lesson but did not receive any new EFMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed CT-152 treatment courses.
|
Digital Therapeutic B - Sham
n=160 Participants
Participants received digital treatment session by using a sham mobile app from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of a SMT exercise only. From Week 7 up to Week 10 participants continued using the sham app but did not receive any new SMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed sham treatment courses.
|
|---|---|---|
|
MADRS Response Rate at Weeks 8 and 10
Week 8
|
54.88 percentage of participants
|
54.84 percentage of participants
|
|
MADRS Response Rate at Weeks 8 and 10
Week 10
|
60.71 percentage of participants
|
57.50 percentage of participants
|
Adverse Events
Digital Therapeutic A - CT-152
Digital Therapeutic B - Sham
Serious adverse events
| Measure |
Digital Therapeutic A - CT-152
n=187 participants at risk
Participants received digital treatment session by using the CT-152 mobile app from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of EFMT exercises and a psychotherapy lesson. From Week 7 up to Week 10 participants continued using the CT-152 app with optional psychotherapy lesson but did not receive any new EFMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed CT-152 treatment courses.
|
Digital Therapeutic B - Sham
n=186 participants at risk
Participants received digital treatment session by using a sham mobile app from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of a SMT exercise only. From Week 7 up to Week 10 participants continued using the sham app but did not receive any new SMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed sham treatment courses.
|
|---|---|---|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.53%
1/187 • From the signing of the informed consent up to end of study (up to Week 10)
Safety sample included all randomized participants who received at least 1 occurrence of either CT-152 or sham use.
|
0.00%
0/186 • From the signing of the informed consent up to end of study (up to Week 10)
Safety sample included all randomized participants who received at least 1 occurrence of either CT-152 or sham use.
|
Other adverse events
| Measure |
Digital Therapeutic A - CT-152
n=187 participants at risk
Participants received digital treatment session by using the CT-152 mobile app from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of EFMT exercises and a psychotherapy lesson. From Week 7 up to Week 10 participants continued using the CT-152 app with optional psychotherapy lesson but did not receive any new EFMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed CT-152 treatment courses.
|
Digital Therapeutic B - Sham
n=186 participants at risk
Participants received digital treatment session by using a sham mobile app from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of a SMT exercise only. From Week 7 up to Week 10 participants continued using the sham app but did not receive any new SMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed sham treatment courses.
|
|---|---|---|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.6%
3/187 • From the signing of the informed consent up to end of study (up to Week 10)
Safety sample included all randomized participants who received at least 1 occurrence of either CT-152 or sham use.
|
5.4%
10/186 • From the signing of the informed consent up to end of study (up to Week 10)
Safety sample included all randomized participants who received at least 1 occurrence of either CT-152 or sham use.
|
Additional Information
Global Clinical Development
Otsuka Pharmaceutical Development & Commercialization, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place