Here is the design of a clinical trial:

Official Title: A Multi-center, Randomized, Controlled Trial to Evaluate the Effectiveness of a Digital Therapeutic (CT-152) as Adjunctive Therapy in Adult Subjects Diagnosed With Major Depressive Disorder

Included conditions:
- Major Depressive Disorder

Study Armgroups:
- {'label': 'Digital Therapeutic A - CT-152', 'type': 'OTHER', 'description': '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.', 'interventionNames': ['Device: CT-152 - Digital Therapeutic']}
- {'label': 'Digital Therapeutic B - Sham', 'type': 'OTHER', 'description': '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.', 'interventionNames': ['Device: Sham']}

Interventions:
- {'type': 'DEVICE', 'name': 'CT-152 - Digital Therapeutic', 'description': 'CT-152 mobile app was used by the participants as per the schedule specified in the respective arm.', 'armGroupLabels': ['Digital Therapeutic A - CT-152']}
- {'type': 'DEVICE', 'name': 'Sham', 'description': 'Sham mobile app was used by the participants as per the schedule specified in the respective arm.', 'armGroupLabels': ['Digital Therapeutic B - Sham']}

Primary Outcomes:
- {'measure': 'Change From Baseline to Week 6 in the MADRS Total Score', 'description': '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.', 'timeFrame': 'Baseline (Day 1) to Week 6'}

Please estimate the sample size based on the assumption: 
85% power, 2-sided α=.05, up to 10% missing/dropout rate
Sample Size Calculation
        The initial sample size was calculated to detect a 3-unit difference between the CT-152 plus ADT and sham DTx plus ADT in the change from baseline in MADRS total score, with 85% power at a 2-sided Î±=.05 level. The resulting sample size was 324 evaluable participants in total (162 in each arm). The full analysis set was defined as all randomized participants who received at least 1 CT-152 or sham DTx session and had at least 2 MADRS total score assessments, 1 of which was at baseline. To compensate for participants who failed to have evaluable assessments of MADRS total score in the full analysis set sample (estimated at up to 10% of all participants), a total of approximately 360 participants (180 in each arm) were planned to be randomized. The trial randomized eligible participants 1:1 across 54 sites. The sample size at any single trial site was capped at approximately 15% of the total number of randomized participants. Randomization was stratified by the trial site.
        Due to the limitations of applying assumptions on the treatment effect size, and to ensure adequate power of the trial, an unmasked interim analysis was conducted by a data monitoring committee, whose members recommended continuing the trial with the planned sample size of 360 participants (actual enrollment included 386 participants).