Major Depressive DisorderCDiA-P4NCT06299787
Cognitive Dysfunction in the Addictions Study - Project 4 (P4)
A study testing intermittent theta burst stimulation in people with Major Depressive Disorder and Alcohol Use Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The prefrontal cortex, although well established as an efficacious target for the treatment of major depressive disorder (MDD), has recently come into favour as a therapeutic target for alcohol use disorders (AUD). Depressive symptoms are also highly prevalent in individuals with AUD. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Major Depressive Disorder, Alcohol Use Disorder
- What is being tested?
- intermittent theta burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 7 Feb 2022to 1 Jul 2025
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- are outpatients;
- are voluntary and competent to consent to treatment;
- have a Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5) diagnosis of AUD based on the MINI;
- do not exhibit problematic use of any substances (excluding nicotine and caffeine), including alcohol, for >1 month;
- are male or female between the ages of 18 - 59;
- screened positive for an MDE based on the MINI without psychotic symptoms
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- are agreeable to keeping their current antidepressant medications and medications for alcohol use disorder constant during the study;
- are reliably taking SUD agonist therapies if appropriate and managed by their clinical team;
- are able to adhere to the study schedule;
- meet the TMS safety criteria.
Who cannot join
- have a concomitant major unstable medical illness;
- are pregnant or intend to get pregnant during the study;
- have possible or probable dementia (based on the Informant Questionnaire on Cognitive Decline in the Elderly that will be administered to any participant with a baseline total score of < 26 on the Montreal Cognitive Assessment (MoCA);
- have failed a course of ECT, due to the lower likelihood of response to rTMS;
- have any significant neurological disorder (e.g., a space occupying brain lesion, a history of stroke, a cerebral aneurysm, a seizure disorder, Parkinson's disease, Huntington's chorea, multiple sclerosis, significant history of head trauma with radiological evidence of intracranial trauma at the time of injury due to risk of possible seizure foci from prior intracranial lesions.
- present with a medical condition, a medication, or a laboratory abnormality that could cause a major depressive episode or significant cognitive impairment in the opinion of the investigator (e.g., hypothyroidism with low TSH, Cushing's disease);
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- have an intracranial implant (e.g., aneurysm clips, shunts, cochlear implants) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
- require a benzodiazepine with a dose equivalent to lorazepam 2 mg/day or higher or any anticonvulsant due to the potential of these medications to limit the efficacy of rTMS [79];
- have an inability to communicate in English fluently enough to complete the clinical assessments.
- have a MINI diagnosis or active symptoms of Bipolar Disorder
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre for Addiction and Mental Health
Toronto, Ontario, M6J 1H4
Daphne Voineskos, MD, 416-535-8501 ext. 30176, daphne.voineskos@camh.ca
About this study
Official title: Assessing the Role of Repetitive Transcranial Magnetic Stimulation on Aberrant Executive Function in the Context of Major Depressive Disorder in Adult Outpatients Seeking Treatment for Alcohol Use Disorder
The prefrontal cortex, although well established as an efficacious target for the treatment of major depressive disorder (MDD), has recently come into favour as a therapeutic target for alcohol use disorders (AUD). Depressive symptoms are also highly prevalent in individuals with AUD. A number of cognitive and psychological processes stemming from the prefrontal cortex, a common treatment target for repetitive transcranial magnetic stimulation (rTMS), are disrupted in both MDD and AUD. The proposed study will enhance the development of theta burst stimulation (TBS) as a new intervention for AUD in the context of depressive symptoms and uses integrated TMS-EEG to identify neurophysiological targets of executive dysfunction in this disorder.
Read the detailed description
The prefrontal cortex, although well established as an efficacious target for the treatment of major depressive disorder (MDD), has recently come into favour as a therapeutic target for alcohol use disorders (AUD). Depressive symptoms are also highly prevalent in individuals with AUD. A number of cognitive and psychological processes stemming from the prefrontal cortex, a common treatment target for repetitive transcranial magnetic stimulation (rTMS), are disrupted in both MDD and AUD. The proposed study will enhance the development of theta burst stimulation (TBS) as a new intervention for AUD in the context of depressive symptoms and uses integrated TMS-EEG to identify neurophysiological targets of executive dysfunction in this disorder.
- Conditions
- Major Depressive Disorder, Alcohol Use Disorder
- Being tested
- intermittent theta burst stimulation, Sham stimulation
- Medical subject headings
- Depressive Disorder, Major, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittent theta burst stimulationDevice
Theta-burst stimulation
Sham stimulationDevice
Stimulation with double-sided B70-type coil
| Study group | Role | What they receive |
|---|---|---|
| Active Bilateral | Active comparator | Bilteral TBS, applied as cTBS over the right DLPFC followed by iTBS over the left DLPFC Receives: Device: intermittent theta burst stimulation |
| Sham | Sham comparator | Sham TBS Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive Function Index - inhibition
Flanker task
Measured: baseline and 4 weeks after baseline (after 20 treatments of active/sham rTMS)
Executive Function Index - working memory
N-back task
Measured: baseline and 4 weeks after baseline (after 20 treatments of active/sham rTMS)
Executive Function Index - set shifting
switch task
Measured: baseline and 4 weeks after baseline (after 20 treatments of active/sham rTMS)
Secondary outcomes (1)
17-Item Hamilton Depression Rating Scale (HRSD-17)
Decrease in 17-Item Hamilton Depression Rating Scale score, 0 is lowest value, 52 is highest, higher value = more severe depression
Measured: baseline and 4 weeks after baseline (after 20 treatments of active/sham rTMS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start7 Feb 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299787
- Sponsor's protocol ID
- 058-2021
- Acronym
- CDiA-P4
- Status last verified
- Mar 2024
- First submitted
- 13 Oct 2022
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Role of Repetitive Transcranial Magnetic Stimulation on Aberrant Executive Function in the Context of Major Depressive Disorder in Adult Outpatients Seeking Treatment for Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT06299787
- Acronym / sponsor ID
- CDiA-P4 / 058-2021
- Conditions
- Major Depressive Disorder, Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 8 Mar 2024 (actual)
- 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 prefrontal cortex, although well established as an efficacious target for the treatment of major depressive disorder (MDD), has recently come into favour as a therapeutic target for alcohol use disorders (AUD). Depressive symptoms are also highly prevalent in individuals with AUD. A number of cognitive and psychological processes stemming from the prefrontal cortex, a common treatment target for repetitive transcranial magnetic stimulation (rTMS), are disrupted in both MDD and AUD. The proposed study will enhance the development of theta burst stimulation (TBS) as a new intervention for AUD in the context of depressive symptoms and uses integrated TMS-EEG to identify neurophysiological targets of executive dysfunction in this disorder.
Detailed description
The prefrontal cortex, although well established as an efficacious target for the treatment of major depressive disorder (MDD), has recently come into favour as a therapeutic target for alcohol use disorders (AUD). Depressive symptoms are also highly prevalent in individuals with AUD. A number of cognitive and psychological processes stemming from the prefrontal cortex, a common treatment target for repetitive transcranial magnetic stimulation (rTMS), are disrupted in both MDD and AUD. The proposed study will enhance the development of theta burst stimulation (TBS) as a new intervention for AUD in the context of depressive symptoms and uses integrated TMS-EEG to identify neurophysiological targets of executive dysfunction in this disorder.
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 Bilateral | Active comparator | Device: intermittent theta burst stimulationBilteral TBS, applied as cTBS over the right DLPFC followed by iTBS over the left DLPFC |
| Sham | Sham comparator | Device: Sham stimulationSham TBS |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- are outpatients;
- are voluntary and competent to consent to treatment;
- have a Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5) diagnosis of AUD based on the MINI;
- do not exhibit problematic use of any substances (excluding nicotine and caffeine), including alcohol, for >1 month;
- are male or female between the ages of 18 - 59;
Key exclusion criteria (10 listed)
- have a concomitant major unstable medical illness;
- are pregnant or intend to get pregnant during the study;
- have possible or probable dementia (based on the Informant Questionnaire on Cognitive Decline in the Elderly that will be administered to any participant with a baseline total score of < 26 on the Montreal Cognitive Assessment (MoCA);
- have failed a course of ECT, due to the lower likelihood of response to rTMS;
- have any significant neurological disorder (e.g., a space occupying brain lesion, a history of stroke, a cerebral aneurysm, a seizure disorder, Parkinson's disease, Huntington's chorea, multiple sclerosis, significant history of head trauma with radiological evidence of intracranial trauma at the time of injury due to risk of possible seizure foci from prior intracranial lesions.
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 |
|---|---|---|
| intermittent theta burst stimulationTheta-burst stimulation | Device | Active Bilateral |
| Sham stimulationStimulation with double-sided B70-type coil | Device | Sham |
Primary outcome
Executive Function Index - inhibition
Time frame: baseline and 4 weeks after baseline (after 20 treatments of active/sham rTMS)
Flanker task
Executive Function Index - working memory
Time frame: baseline and 4 weeks after baseline (after 20 treatments of active/sham rTMS)
N-back task
Executive Function Index - set shifting
Time frame: baseline and 4 weeks after baseline (after 20 treatments of active/sham rTMS)
switch task
1 secondary outcome
17-Item Hamilton Depression Rating Scale (HRSD-17)
Time frame: baseline and 4 weeks after baseline (after 20 treatments of active/sham rTMS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intermittent theta burst stimulation in people with Major Depressive Disorder and Alcohol Use Disorder, run by Centre for Addiction and Mental Health 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 10 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 8 Mar 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 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. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daphne Voineskos, MD (416-535-8501 ext. 30176, daphne.voineskos@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Executive Function Index - inhibition (time frame: baseline and 4 weeks after baseline (after 20 treatments of active/sham rTMS)). The study lists 3 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 8 Mar 2024.