Major Depressive DisorderMDDNETNCT00998569
Neurocognitive Enhancement in Major Depressive Disorder
A study testing Neurocognitive Enhancement and Wait List in people with Major Depressive Disorder, run by Queen's University at 1 site in Canada.
Trial summary
The purpose of this study is to examine the effects of neurocognitive enhancement on cognitive abilities and related social and adaptive behaviours in individuals diagnosed with major depressive disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Neurocognitive Enhancement and Wait List
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2009to Mar 2012
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female.
- Subjects will be between the ages of 18 and 65, which is the age range with available normative comparison data.
Who cannot join
- Presence of a medical diagnosis that is associated with known cognitive impairments, such as multiple sclerosis, cerebrovascular accident, dementia, or history of traumatic brain injury.
- Subjects with a reading level below grade 6, as assessed with the Wide Range Achievement Test - Reading Recognition Subtest, will be excluded because of the likelihood of not understanding task instructions.
- Subjects with uncorrectable vision or hearing impairment that would preclude valid assessments or intervention procedures.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the effects of neurocognitive enhancement on cognitive abilities and related social and adaptive behaviours in individuals diagnosed with major depressive disorder. Subjects in this study will be randomized to receive Neurocognitive Enhancement Therapy (NET) or to a wait list and then NET . Secondary aims include examining whether the cognitive benefits are potentiated by repeated exposure during in-home practice with complementary exercises. Additionally, the investigators will examine the durability of the effects and their generalization to functional capacity and everyday functional performance after completion of the groups.
- Conditions
- Major Depressive Disorder
- Being tested
- Neurocognitive Enhancement, Wait List
- 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.
Neurocognitive EnhancementBehavioural
Neurocognitive Enhancement Therapy (NET) uses behavioural treatment strategies that are designed to improve a range of cognitive skills. NET uses strategies such as coaching, repetition, practice, teaching, group discussion, and compensation for deficits by using cognitive strengths.
Wait ListBehavioural
Participants will be wait listed for 10 weeks, following which time they will receive the intervention previously described.
| Study group | Role | What they receive |
|---|---|---|
| Neurocognitive Enhancement | Experimental | neurocongnitive enhancement Receives: Behavioral: Neurocognitive Enhancement |
| Wait List | Other | no intervention Receives: Behavioral: Wait List |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance on paper and pencil assessments of neurocognition after treatment, compared to baseline assessment performance
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2012
- Study completionMar 2012
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Bowie, Queen's University
- Investigators
- Christopher Bowie, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998569
- Sponsor's protocol ID
- PSYC-092-09
- Acronym
- MDDNET
- Status last verified
- Aug 2015
- First submitted
- 14 Oct 2009
- Last updated
- 31 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Enhancement in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00998569
- Acronym / sponsor ID
- MDDNET / PSYC-092-09
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 20 Oct 2009 (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 examine the effects of neurocognitive enhancement on cognitive abilities and related social and adaptive behaviours in individuals diagnosed with major depressive disorder. Subjects in this study will be randomized to receive Neurocognitive Enhancement Therapy (NET) or to a wait list and then NET . Secondary aims include examining whether the cognitive benefits are potentiated by repeated exposure during in-home practice with complementary exercises. Additionally, the investigators will examine the durability of the effects and their generalization to functional capacity and everyday functional performance after completion of the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurocognitive Enhancement | Experimental | Behavioral: Neurocognitive Enhancementneurocongnitive enhancement |
| Wait List | Other | Behavioral: Wait Listno intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or Female.
- Subjects will be between the ages of 18 and 65, which is the age range with available normative comparison data.
Key exclusion criteria (3 listed)
- Presence of a medical diagnosis that is associated with known cognitive impairments, such as multiple sclerosis, cerebrovascular accident, dementia, or history of traumatic brain injury.
- Subjects with a reading level below grade 6, as assessed with the Wide Range Achievement Test - Reading Recognition Subtest, will be excluded because of the likelihood of not understanding task instructions.
- Subjects with uncorrectable vision or hearing impairment that would preclude valid assessments or intervention procedures.
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 |
|---|---|---|
| Neurocognitive EnhancementNeurocognitive Enhancement Therapy (NET) uses behavioural treatment strategies that are designed to improve a range of cognitive skills. NET uses strategies such as coaching, repetition, practice, teaching, group discussion, and compensation for deficits by using cognitive strengths. | Behavioural | Neurocognitive Enhancement |
| Wait ListParticipants will be wait listed for 10 weeks, following which time they will receive the intervention previously described. | Behavioural | Wait List |
Primary outcome
Performance on paper and pencil assessments of neurocognition after treatment, compared to baseline assessment performance
Time frame: 20 weeks
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 31 Aug 2015.
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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 Bowie, PhD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurocognitive Enhancement and Wait List in people with Major Depressive Disorder, run by Queen's University at 1 site in Canada.
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 2 inclusion and 3 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 31 Aug 2015. 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 Canada. 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?
Performance on paper and pencil assessments of neurocognition after treatment, compared to baseline assessment performance (time frame: 20 weeks). 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 31 Aug 2015.