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| Name | Class |
|---|---|
| Click Therapeutics, Inc. | INDUSTRY |
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This study compares the effectiveness of 2 digital therapeutics in adult participants diagnosed with major depressive disorder (MDD) who are on antidepressant therapy (ADT) monotherapy for the treatment of depression.
This is a pivotal, 13-week, multi-center, randomized, controlled trial to evaluate the effectiveness and safety of two digital therapeutics in adult participants diagnosed with MDD who are on antidepressant therapy (ADT) monotherapy for the treatment of depression.
The trial consists of a 3-week screening period, a 6-week treatment period, and a 4-week extension. Trial visits will be conducted remotely either by video visit or telephone. The screening visit may be performed in person at the discretion of the investigator. Eligible participants will be randomized to 1 of 2 digital therapeutics within a mobile application that will reside on the participant's personal iPhone or smartphone.
The trial population will include male and female participants between 22 and 64 years of age with a primary diagnosis of major depressive disorder (MDD) who are on an ADT for the treatment of depression. This trial will analyze data gathered from approximately 360 participants in the United States. An interim analysis will be conducted when a targeted sample of the first 180 participants has completed week 6 or discontinued the trial prior to week 6.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Therapeutic A - CT-152 | Other | 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 | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-152 - Digital Therapeutic | Device | CT-152 mobile app was used by the participants as per the schedule specified in the respective arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 6 in the MADRS Total Score | 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. | Baseline (Day 1) to Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 6 in the GAD-7 Total Score | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Weeks 2 and 4 in the MADRS Total Score | 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. |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding sites, contact 844-687-8522 | Dallas | Texas | 75231 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39163592 | Derived | Rothman B, Slomkowski M, Speier A, Rush AJ, Trivedi MH, Lawson E, Fahmy M, Carpenter D, Chen D, Forbes A. Evaluating the Efficacy of a Digital Therapeutic (CT-152) as an Adjunct to Antidepressant Treatment in Adults With Major Depressive Disorder: Protocol for the MIRAI Remote Study. JMIR Res Protoc. 2024 Aug 20;13:e56960. doi: 10.2196/56960. |
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Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
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.
Participants were enrolled at 37 investigative sites in the United States from 25 February 2021 to 26 October 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Randomized sample included all participants allocated based on the randomization process and recorded in the database.
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| ID | Title | Description |
|---|---|---|
| BG000 | Digital Therapeutic A - CT-152 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Week 6 in the MADRS Total Score | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1) to Week 6 |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Digital Therapeutic A - CT-152 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient Ischaemic Attack | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Development | Otsuka Pharmaceutical Development & Commercialization, Inc. | 1-609-524-6788 | clinicaltransparency@otsuka-us.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 3, 2021 | Sep 19, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 16, 2022 | Sep 19, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Sham | Device | Sham mobile app was used by the participants as per the schedule specified in the respective arm. |
|
| Baseline (Day 1) to Week 6 |
| Baseline (Day 1) to Weeks 2 and 4 |
| Change From Baseline to Weeks 2 and 4 in the GAD-7 Total Score | 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. | Baseline (Day 1) to Weeks 2 and 4 |
| MADRS Response Rate at Weeks 2, 4, and 6 | 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. | Baseline (Day 1), Weeks 2, 4 and 6 |
| Change From Baseline to Weeks 2, 4 and 6 in the Clinical Global Impression - Severity of Illness (CGI-S) Score | 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. | Baseline (Day 1) to Weeks 2, 4 and 6 |
| Change From Baseline to Week 6 in the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Total Score | 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. | Baseline (Day 1) to Week 6 |
| Change From Screening to Weeks 4 and 6 in the PHQ-9 Total Score. | 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. | Screening to Weeks 4 and 6 |
| MADRS Partial Response at Weeks 2, 4 and 6 | 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. | Baseline (Day 1), Weeks 2, 4 and 6 |
| MADRS Response Rate at Weeks 8 and 10 | 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. | Baseline (Day 1), Weeks 8 and 10 |
| Lost to Follow-up |
|
| Protocol Deviation |
|
| Technical Problem |
|
| Withdrawal by Subject |
|
| Reason Not Specified |
|
| BG001 | 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 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| MADRS Total Score | 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. | Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Mean | Standard Deviation | score on a scale |
|
| Generalized Anxiety Disorder-7 (GAD-7) Total Score | 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. | Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Mean | Standard Deviation | score on a scale |
|
| OG000 | Digital Therapeutic A - CT-152 | 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. |
| OG001 | 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 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. |
|
|
|
| Secondary | Change From Baseline to Week 6 in the GAD-7 Total Score | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1) to Week 6 |
|
|
|
|
| Other Pre-specified | Change From Baseline to Weeks 2 and 4 in the MADRS Total Score | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1) to Weeks 2 and 4 |
|
|
|
|
| Other Pre-specified | Change From Baseline to Weeks 2 and 4 in the GAD-7 Total Score | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1) to Weeks 2 and 4 |
|
|
|
|
| Other Pre-specified | MADRS Response Rate at Weeks 2, 4, and 6 | 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. | 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. | Posted | Number | percentage of participants | Baseline (Day 1), Weeks 2, 4 and 6 |
|
|
|
|
| Other Pre-specified | Change From Baseline to Weeks 2, 4 and 6 in the Clinical Global Impression - Severity of Illness (CGI-S) Score | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1) to Weeks 2, 4 and 6 |
|
|
|
|
| Other Pre-specified | Change From Baseline to Week 6 in the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Total Score | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1) to Week 6 |
|
|
|
|
| Other Pre-specified | Change From Screening to Weeks 4 and 6 in the PHQ-9 Total Score. | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Screening to Weeks 4 and 6 |
|
|
|
|
| Other Pre-specified | MADRS Partial Response at Weeks 2, 4 and 6 | 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. | 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. | Posted | Number | percentage of participants | Baseline (Day 1), Weeks 2, 4 and 6 |
|
|
|
|
| Other Pre-specified | MADRS Response Rate at Weeks 8 and 10 | 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. | 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. | Posted | Number | percentage of participants | Baseline (Day 1), Weeks 8 and 10 |
|
|
|
|
| 0 |
| 187 |
| 1 |
| 187 |
| 3 |
| 187 |
| EG001 | 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 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. | 0 | 186 | 0 | 186 | 10 | 186 |
Not provided
Not provided
| Unknown or Not Reported |
|
| Week 4 |
|
|
Week 4
| MMRM |
| 0.0828 |
p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction. |
| Treatment Difference |
| -1.45 |
| 2-Sided |
| 95 |
| -3.10 |
| 0.19 |
| Superiority |
| Week 4 |
|
|
Week 4
| MMRM |
| 0.4948 |
p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction. |
| Treatment Difference |
| -0.28 |
| 2-Sided |
| 95 |
| -1.09 |
| 0.53 |
| Superiority |
| Week 4 |
|
|
| Week 6 |
|
|
Week 4
| Cochran-Mantel-Haenszel |
| 0.2939 |
p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center. |
| Ratio of Response Rate |
| 1.31 |
| 2-Sided |
| 95 |
| 0.79 |
| 2.16 |
| Superiority |
| Week 6 | Cochran-Mantel-Haenszel | 0.0884 | p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center. | Ratio of Response Rate | 1.38 | 2-Sided | 95 | 0.96 | 1.99 | Superiority |
| Week 4 |
|
|
| Week 6 |
|
|
Week 4
| MMRM |
| 0.0003 |
p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction. |
| Treatment Difference |
| -0.32 |
| 2-Sided |
| 95 |
| -0.50 |
| -0.15 |
| Superiority |
| Week 6 | MMRM | 0.0098 | p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction. | Treatment Difference | -0.26 | 2-Sided | 95 | -0.46 | -0.06 | Superiority |
| Week 6 |
|
|
Week 6
| MMRM |
| 0.0029 |
p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction. |
| Treatment Difference |
| -1.58 |
| 2-Sided |
| 95 |
| -2.62 |
| -0.54 |
| Superiority |
| Week 4 |
|
|
| Week 6 |
|
|
Week 4
| Cochran-Mantel-Haenszel |
| 0.5102 |
p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center. |
| Ratio of Response Rate |
| 1.16 |
| 2-Sided |
| 95 |
| 0.75 |
| 1.78 |
| Superiority |
| Week 6 | Cochran-Mantel-Haenszel | 0.5342 | p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center. | Ratio of Response Rate | 1.15 | 2-Sided | 95 | 0.74 | 1.79 | Superiority |
| Week 10 |
|
|
| Ratio of Response Rate |
| 1.05 |
| 2-Sided |
| 95 |
| 0.88 |
| 1.25 |
| Superiority |