Major Depressive DisorderMDDNCT02922556
Piloting a Novel, Mobile Cognitive Training Tool for Patients With Major Depressive Disorder (MDD)
A study testing Computerized Plasticity-Based Adaptive Cognitive Training and Commercially available computerized training in people with Major Depressive Disorder, run by Posit Science Corporation at 1 site in United States.
Trial summary
To assess the efficacy of a mobile-device-deployed cognitive emotional treatment for depression (Moodify) versus an active control treatment (commercially available computer games). Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Computerized Plasticity-Based Adaptive Cognitive Training and Commercially available computerized training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 21 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must 18 to 85 years or older and not pregnant
- Participants must be fluent in English
- Participants must be able to engage with computerized cognitive tasks as required in order to participate in this study.
- Normal vision (or corrected to normal vision)
- Participants must be willing to commit to the time requirements of the study as evidenced by written, informed consent.
- Participants must meet diagnostic criteria for MDD
Who cannot join
- Participants report or present a hand tremor that prevents the use of a computer mouse or keyboard
- Participants unable to perform neuropsychological evaluations
- Participants cannot comprehend or follow instructions
- Participants not capable of giving informed consent
- Participants who appear to be intoxicated or under the influence of a controlled substance
- Participants with a history of significant medical diseases or multiple neurological events of the head
Show all 9Show fewer
- Participants with serious or unstable medical illness (e.g. cardiovascular, hepatic, renal, endocrine, neurologic disease)
- Participants with a history or current diagnosis to specific Diagnostic and Statistical Manual (DSM)-IV psychiatric illness such as (but not limited to): organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorder Not Otherwise Specific, bipolar disorder, substance dependence and substance abuse
- Participants with a history of seizure disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Posit Science Corporation
San Francisco, California, 94111
About this study
To assess the efficacy of a mobile-device-deployed cognitive emotional treatment for depression (Moodify) versus an active control treatment (commercially available computer games).
Read the detailed description
The study will involve a randomized, controlled, double-blind trial to assess the efficacy of a mobile-device-deployed cognitive emotional treatment for depression (Moodify) versus an active control treatment (commercially available computer games). Moodify is comprised of a novel continuous performance task (CPT) to improve cognitive slowing and lethargy often present in cases of major depressive disorder. This training method is based on an existing, validated cognitive training paradigm (tonic and phasic attention training, TAPAT1; WIRB Study No. 1126399). Moodify will also employ two additional cognitive training modules previously validated in this and other clinical populations.
- Conditions
- Major Depressive Disorder
- Being tested
- Computerized Plasticity-Based Adaptive Cognitive Training, Commercially available computerized training
- 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.
Computerized Plasticity-Based Adaptive Cognitive TrainingOther
Also called Moodify
Commercially available computerized trainingOther
Also called Games
| Study group | Role | What they receive |
|---|---|---|
| Experimental Treatment | Experimental | Computerized plasticity-based adaptive cognitive training (Moodify) requiring a total maximum of 50 treatment hours, 3-5 times weekly, 30-45 minutes each session. Receives: Other: Computerized Plasticity-Based Adaptive Cognitive Training |
| Active Comparator | Active comparator | Commercially available computerized training (Games) requiring a total maximum of 50 treatment hours, 3-5 times weekly, 30-45 minutes each session. Receives: Other: Commercially available computerized training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change scores for depressive symptoms using Beck Depression Scale (BDI)
Measured: 3 months and 6 months
Change scores for anxiety symptoms using Generalized Anxiety Disorder (GAD-7)
Measured: 3 months and 6 months
Change scores for functional health and well being using the 12-Item Short Form Health Survey (SF-12)
Measured: 3 months and 6 months
Change scores for depressive symptoms using Patient Health Questionnaire (PHQ-9)
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startSep 2015
- Primary completion21 Jun 2019
- Study completion21 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Posit Science Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922556
- Sponsor's protocol ID
- PSC-1008-2015
- Acronym
- MDD
- Status last verified
- Jun 2019
- First submitted
- 13 Jul 2016
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting a Novel, Mobile Cognitive Training Tool for Patients With Major Depressive Disorder (MDD)
- ClinicalTrials.gov ID
- NCT02922556
- Acronym / sponsor ID
- MDD / PSC-1008-2015
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Posit Science CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- 21 Jun 2019 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy of a mobile-device-deployed cognitive emotional treatment for depression (Moodify) versus an active control treatment (commercially available computer games).
Detailed description
The study will involve a randomized, controlled, double-blind trial to assess the efficacy of a mobile-device-deployed cognitive emotional treatment for depression (Moodify) versus an active control treatment (commercially available computer games). Moodify is comprised of a novel continuous performance task (CPT) to improve cognitive slowing and lethargy often present in cases of major depressive disorder. This training method is based on an existing, validated cognitive training paradigm (tonic and phasic attention training, TAPAT1; WIRB Study No. 1126399). Moodify will also employ two additional cognitive training modules previously validated in this and other clinical populations.
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 |
|---|---|---|
| Experimental Treatment | Experimental | Other: Computerized Plasticity-Based Adaptive Cognitive TrainingComputerized plasticity-based adaptive cognitive training (Moodify) requiring a total maximum of 50 treatment hours, 3-5 times weekly, 30-45 minutes each session. |
| Active Comparator | Active comparator | Other: Commercially available computerized trainingCommercially available computerized training (Games) requiring a total maximum of 50 treatment hours, 3-5 times weekly, 30-45 minutes each session. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants must 18 to 85 years or older and not pregnant
- Participants must be fluent in English
- Participants must be able to engage with computerized cognitive tasks as required in order to participate in this study.
- Normal vision (or corrected to normal vision)
- Participants must be willing to commit to the time requirements of the study as evidenced by written, informed consent.
Key exclusion criteria (9 listed)
- Participants report or present a hand tremor that prevents the use of a computer mouse or keyboard
- Participants unable to perform neuropsychological evaluations
- Participants cannot comprehend or follow instructions
- Participants not capable of giving informed consent
- Participants who appear to be intoxicated or under the influence of a controlled substance
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 |
|---|---|---|
| Computerized Plasticity-Based Adaptive Cognitive TrainingAlso: Moodify | Other | Experimental Treatment |
| Commercially available computerized trainingAlso: Games | Other | Active Comparator |
Primary outcome
Change scores for depressive symptoms using Beck Depression Scale (BDI)
Time frame: 3 months and 6 months
Change scores for anxiety symptoms using Generalized Anxiety Disorder (GAD-7)
Time frame: 3 months and 6 months
Change scores for functional health and well being using the 12-Item Short Form Health Survey (SF-12)
Time frame: 3 months and 6 months
Change scores for depressive symptoms using Patient Health Questionnaire (PHQ-9)
Time frame: 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
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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 Computerized Plasticity-Based Adaptive Cognitive Training and Commercially available computerized training in people with Major Depressive Disorder, run by Posit Science Corporation 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 6 inclusion and 9 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 25 Jun 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 scores for depressive symptoms using Beck Depression Scale (BDI) (time frame: 3 months and 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2019.