Major Depressive DisorderMIRAINCT04770285
Trial to Evaluate the Effectiveness of a Digital Therapeutics in Adults Diagnosed With Major Depressive Disorder
A study testing CT-152 - Digital Therapeutic in people with Major Depressive Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 to 64 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- CT-152 - Digital Therapeutic
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 386 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2021to 26 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants with a current primary diagnosis of MDD.
- Participants with a Hamilton Rating Scale for Depression, 17-item (HAM-D17) score ≥ 18
- Participants who are receiving treatment with an adequate dose and duration of an ADT and who are willing to maintain that same treatment regimen for the duration of this trial.
- Participants who are the only users of an iPhone or an Android smartphone, and agree to download and use the digital mobile application as required by the protocol.
Who cannot join
- Participants with an inadequate response to > 1 adequate trial of ADT for the current episode.
- Participants who are receiving or have received psychotherapy within 90 days prior to screening.
- Participants who are currently using a computer, web, or smartphone software-based application for mental health or depression.
- Participants with a history of schizophrenia, schizoaffective disorder, other psychotic disorder, or Bipolar I/II disorder, or current posttraumatic stress disorder, panic disorder, obsessive-compulsive disorder, or personality disorder
- General Anxiety Disorder/social anxiety can be present as long as they are not the main disorder requiring treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
For additional information regarding sites, contact 844-687-8522
Dallas, Texas, 75231
About this study
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
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.
Read the detailed description
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.
- Conditions
- Major Depressive Disorder
- Being tested
- CT-152 - Digital Therapeutic, Sham
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-152 - Digital TherapeuticDevice
CT-152 mobile app was used by the participants as per the schedule specified in the respective arm.
ShamDevice
Sham mobile app was used by the participants as per the schedule specified in the respective arm.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CT-152 - Digital Therapeutic |
| 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. Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 1) to Week 6
Secondary outcomes (1)
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.
Measured: Baseline (Day 1) to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start25 Feb 2021
- Primary completion26 Oct 2022
- Study completion26 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 386 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Click Therapeutics, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770285
- Sponsor's protocol ID
- 345-201-00002
- Acronym
- MIRAI
- Status last verified
- Sep 2024
- First submitted
- 19 Feb 2021
- Last updated
- 16 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39163592
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04770285
- Acronym / sponsor ID
- MIRAI / 345-201-00002
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Click Therapeutics, Inc.
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 25 Feb 2021 (actual)
- Results
- Posted 16 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Therapeutic A - CT-152 | Other | Device: CT-152 - Digital TherapeuticParticipants 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 | Device: ShamParticipants 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. |
Who may qualify
- Ages
- 22 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants with a current primary diagnosis of MDD.
- Participants with a Hamilton Rating Scale for Depression, 17-item (HAM-D17) score ≥ 18
- Participants who are receiving treatment with an adequate dose and duration of an ADT and who are willing to maintain that same treatment regimen for the duration of this trial.
- Participants who are the only users of an iPhone or an Android smartphone, and agree to download and use the digital mobile application as required by the protocol.
Key exclusion criteria (5 listed)
- Participants with an inadequate response to > 1 adequate trial of ADT for the current episode.
- Participants who are receiving or have received psychotherapy within 90 days prior to screening.
- Participants who are currently using a computer, web, or smartphone software-based application for mental health or depression.
- Participants with a history of schizophrenia, schizoaffective disorder, other psychotic disorder, or Bipolar I/II disorder, or current posttraumatic stress disorder, panic disorder, obsessive-compulsive disorder, or personality disorder
- General Anxiety Disorder/social anxiety can be present as long as they are not the main disorder requiring treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-152 - Digital TherapeuticCT-152 mobile app was used by the participants as per the schedule specified in the respective arm. | Device | Digital Therapeutic A - CT-152 |
| ShamSham mobile app was used by the participants as per the schedule specified in the respective arm. | Device | Digital Therapeutic B - Sham |
Primary outcome
Change From Baseline to Week 6 in the MADRS Total Score
Time frame: Baseline (Day 1) to Week 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. A negative change from baseline indicates improvement. Least square (LS) mean was estimated using Mixed Model Repeated Measures (MMRM) method.
1 secondary outcome
Change From Baseline to Week 6 in the GAD-7 Total Score
Time frame: Baseline (Day 1) to Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39163592Rothman 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT-152 - Digital Therapeutic in people with Major Depressive Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Week 6 in the MADRS Total Score (time frame: Baseline (Day 1) to Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04770285, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.