Major Depressive DisorderPhase 3NCT01203683
Testing the Effectiveness of a Computer-based Program for Depression
A Phase 3 study testing Active computer-based training and Inert computer training in people with Major Depressive Disorder, run by University of Texas at Austin at 1 site in United States.
Trial summary
The purpose of this study is to determine whether completing a computer-based program alters changes how the brain processes emotional information and improves symptoms of depression. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Active computer-based training and Inert computer training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Oct 2013
- Phase
- Phase 3
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Major Depressive Disorder
Who cannot join
- Substance dependence, psychotic disorder, bipolar disorder, schizophrenia, current psychotherapy, medications other than selective serotonin reuptake inhibitors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Attention Training for Major Depressive Disorder
The purpose of this study is to determine whether completing a computer-based program alters changes how the brain processes emotional information and improves symptoms of depression.
- Conditions
- Major Depressive Disorder
- Being tested
- Active computer-based training, Inert computer training
- Keywords
- depression
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active computer-based trainingBehavioural
8 sessions across 4 weeks.
Inert computer trainingBehavioural
8 sessions across 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active Computer-Based Program | Experimental | Putatively therapeutic computer program. Receives: Behavioral: Active computer-based training |
| Placebo computer-based program | Placebo comparator | Inert computer program. Receives: Behavioral: Inert computer training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory-II
Questionnaire to assess depression symptom severity
Measured: Week 4, Week 9
Secondary outcomes (2)
Structured Clinical Interview for DSM-IV diagnoses
Diagnostic interview to assess for presence of Major depressive disorder (MDD).
Measured: Week 9
Neural processing of emotion stimuli
fMRI paradigm to assess neural changes in how individuals processes emotional stimuli
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startJan 2011
- Primary completionOct 2013
- Study completionOct 2013
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.
- More trials run by University of Texas at AustinThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Beevers, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203683
- Sponsor's protocol ID
- 2010-09-0004
- Status last verified
- Oct 2013
- First submitted
- 15 Sep 2010
- Last updated
- 10 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attention Training for Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01203683
- Acronym / sponsor ID
- 2010-09-0004
- Conditions
- Major Depressive Disorder
- Keywords
- depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 16 Sep 2010 (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.
The purpose of this study is to determine whether completing a computer-based program alters changes how the brain processes emotional information and improves symptoms of depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Computer-Based Program | Experimental | Behavioral: Active computer-based trainingPutatively therapeutic computer program. |
| Placebo computer-based program | Placebo comparator | Behavioral: Inert computer trainingInert computer program. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Major Depressive Disorder
Key exclusion criteria (1 listed)
- Substance dependence, psychotic disorder, bipolar disorder, schizophrenia, current psychotherapy, medications other than selective serotonin reuptake inhibitors
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 |
|---|---|---|
| Active computer-based training8 sessions across 4 weeks. | Behavioural | Active Computer-Based Program |
| Inert computer training8 sessions across 4 weeks. | Behavioural | Placebo computer-based program |
Primary outcome
Beck Depression Inventory-II
Time frame: Week 4, Week 9
Questionnaire to assess depression symptom severity
2 secondary outcomes
Structured Clinical Interview for DSM-IV diagnoses
Time frame: Week 9
Neural processing of emotion stimuli
Time frame: Week 4
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 10 Oct 2013.
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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.
Christopher Beevers, PhD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Active computer-based training and Inert computer training in people with Major Depressive Disorder, run by University of Texas at Austin 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 1 inclusion and 1 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 10 Oct 2013. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Beck Depression Inventory-II (time frame: Week 4, Week 9). 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 10 Oct 2013.