DepressionPhase 4NCT04620499
PEER Interactive to Inform the Prescription of Medications
A Phase 4 study testing EEG in people with Depression, run by University of Ottawa at 2 sites in Canada.
Trial summary
Improving the prescription accuracy of psychotropic medications for military personnel diagnosed with neuropsychiatric disorders is imperative to promote accelerated treatment response and recovery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- EEG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesCanada
- Study dates
- Feb 2016to Dec 2021
- Phase
- Phase 4
- 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 and female subjects between the ages of 18 - 65 years of age or older who speak and read English.
- Participants able to provide written informed consent to participate in the study.
- Participants with a primary diagnosis of a DSM-V depressive disorder, including subjects with comorbidity of a non-psychotic behavioral disorder.
- Participants with comorbidity of mild traumatic brain injury (mTBI) are eligible for inclusion in this study. mTBI will be defined according to best clinical practice guidelines. The subject should have experienced no more than 30 minutes of loss of consciousness, less than a 24 hour alteration in consciousness or mental status, less than 24 hours of post-traumatic amnesia and a Glasgow Coma Scale (best available score in the first 24 hours) of 13 or greater.
- Participants with comorbidity of post-traumatic stress disorder (PTSD) are eligible for inclusion in this study. A score of 45 or greater on the PTSD Checklist Military/Civilian (PCL-M/C) measurement tool will qualify a subject for inclusion of diagnosis of PTSD as a comorbid condition.
- Able to stop non-essential medications, including drugs of abuse, for 5 half-lives of the medication(s). See Appendix B for a list of the five half-life time periods for medications.
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- The potential subject's primary care physician may be consulted to make these determinations.
- Able to be washed out of non-essential medications within 14 days, i.e. 5 half-lives are not longer than 14 days (See Appendix B).
- Participants will be selected from patients on the psychiatric inpatient ward, partially hospitalized patients, and psychiatric outpatients.
- Ability to comply with the requirements of the study.
Who cannot join
- Male and female subject less than 18 years old or greater than 65 years old
- Participants who cannot provide written informed consent
- Diagnosis of a psychotic disorder.
- History of, or current, open head brain trauma.
- Subjects with comorbidity of mild traumatic brain injury (mTBI) or traumatic brain injury (TBI) who experienced greater than 30 minutes loss of consciousness, greater than 24 hour alteration in consciousness or mental status, greater than 24 hours of post traumatic amnesia, or a Glasgow Coma Scale (best available score in first 24 hours) of less than 13.
- Participants who, in the opinion of the research staff or medical prescriber for non-psychotropic drugs (e.g., primary care, cardiovascular, etc.), would not be good candidates to be washed out of their medications and - in the case of outpatients - are unable to washout medications and/or supplements in a period of 14 days or less.
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- Participants currently prescribed Fluoxetine when assessed for study entry (due to long metabolite half-life).
- History of: craniotomy, cerebral metastases, cerebrovascular accident; current diagnosis of seizure disorder, schizophrenia, schizo-affective disorder, dementia, mental retardation, or major depression with psychotic features; or use of depot neuroleptics in last 12 months.
- Clinically significant medical illness, including thyroid disorders, which cannot be remediated with medication, e.g. synthroid.
- Participation in any other therapeutic drug study within 60 days preceding inclusion.
- Known pregnancy and/or lactation, or intent to become pregnant during this study.
- Chronic or acute pain requiring prescription pain medication(s) (narcotic or synthetic narcotic).
- Candidates with any metal, shrapnel or other similar objects in the head that could affect the QEEG.
- Candidates currently stable and considered to be at Maximum Medical Improvement (MMI) on current medications.
- Participant has a positive urine drug screen.
- Participant has active suicidal intent.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
The Royal
Ottawa, Ontario, K1Z 7K4
University of Ottawa Institute of Mental Health Research
Ottawa, Ontario, K1Z 7K4
About this study
Official title: A Prospective, Single-Blinded, Randomized, Multicentre Study to Evaluate the Utility, Safety, and Efficacy of Using PEER Interactive to Inform the Prescription of Medications to Subjects With a Primary Diagnosis of a Depressive Disorder
Improving the prescription accuracy of psychotropic medications for military personnel diagnosed with neuropsychiatric disorders is imperative to promote accelerated treatment response and recovery. This study will determine whether PEER (Psychiatric EEG Evaluation Registry) Interactive (a comparison of a quantitative electroencephalogram (QEEG) to an existing database of subject outcomes) provides an objective adjunctive tool that is more effective in guiding treatment than the current standard of practice in the treatment of military personnel suffering from non-psychotic mental illness. For this prospective, multicenter, randomized, single-blinded, controlled study, 100 participants with a primary diagnosis of a DSM-V depressive disorder, with comorbidity of non-psychotic behavioral disorders to include mild Traumatic Brain Injury (mTBI) and Post Traumatic Stress Disorder (PTSD), will be enrolled. Participants will be randomized into a control or experimental group, and all will undergo a quantitative electroencephalogram (QEEG). For the experimental group, research staff will receive an Outcome Report from PEER Interactive and will follow the guidance of the Report to inform treatment. For the control group, research staff will not receive a participant Outcome Report from PEER Interactive and these participants will be treated based on current standards. For the control group, Outcome Reports will be sequestered for post-hoc analysis. Research staff in collaboration with CNS Response (the Sponsor) will evaluate and validate if the guidance provided by PEER Interactive correlates with the predicted participant outcome. Research staff in collaboration with the Sponsor will also evaluate if the treatment guidance provided by PEER Interactive results in improved mental health and/or a reduction of risk as measured by a reduction in severe adverse events, including suicidality.
Read the detailed description
Study Design
This is a prospective, single-blinded, randomized, multicenter study to evaluate the utility, safety, and efficacy of using PEER Interactive to inform the prescription of medications to participants with a primary diagnosis of a depressive disorder, with or without comorbidity of non-psychotic behavioral disorders, versus treatment as usual.
This study is observational in nature, in that the participants in the control group will be treated according to treatment as usual and best judgment of the treating clinician. The participants in the experimental group will be treated with adjunctive information provided by the PEER Interactive Report. It is a controlled study in that the schedule of visits, procedures and measurements will be defined by the protocol in order to provide consistent data for both the control and experimental groups.
Participants will be blinded as to presence/use of the PEER Interactive Report and will provide the primary efficacy outcome evaluation. All participants will be randomized into a control or experimental group. All participants will receive a quantitative electroencephalogram (QEEG). For those participants in the experimental group, the research staff will receive an Outcome Report from PEER Interactive. The clinician in the experimental group will use the PEER Interactive Report in the medication prescription process. For the control group, the research staff will not receive an Outcome Report. Outcome Reports for the control group will be sequestered for post-hoc analysis.
The research staff will incorporate the information provided by the Outcome Report from PEER Interactive in their prescription decisions. PEER Interactive provides adjunctive information to assist the treating clinician in the clinical decision process. For the experimental group the research staff is expected to follow the guidance of the subject's PEER Outcome Report as regards to the participant's responsiveness to the on-label medications noted in the Report. Although the study staff is strongly encouraged to use the guidance in the medication decision, prescription of medication is a clinical decision and will be made by the research staff. A decision to not follow the guidance of the Report should be documented and explained. In some cases, the Report may indicate sensitivity for a medication to which the subject has not been responsive in previous treatment - or - if effective for the diagnosed condition may cause/have caused an undesired side effect e.g. rash, nausea, etc. The clinician must always consider subject history in the treatment decision. We expect the Report will indicate that the participant will not be responsive to the previous treatment, and therefore, the treatment should not be prescribed. The PEER Report informs medication decisions as a part of treatment. If the only medication indicated by the report is a medication the participant has had poor experience with; the participant should be treated with another medication indicated as responsive by the Report. In the event the Report indicates the participant is not responsive to any of the on-label medications in the Report, the treating clinician may prescribe according to best clinical judgment. The research staff will note the basis for all medication decisions in the subject's treatment/study file. The only change to standard of care is the use of the PEER Report to inform medication decisions for the experimental group e.g. If a participant is receiving psychotherapy/ counseling along with medical therapy prior to enrollment, the participant will continue with all other therapies as usual.
Following the guidance of the PEER Outcome Report means prescribing any medication the report indicates the subject would be responsive to and not prescribing medications the report indicates the subject would not be responsive to. The PEER Outcome Report should be followed for up to two 'medication trials' to be considered as following the guidance of the report. A 'medication trial' is defined as prescribing a new medication to treat the subject. This includes augmentation and/or switching to a different medication. Dosing adjustments are not considered a medication trial.
The research staff, in collaboration with the sponsor, will evaluate and validate how closely the information provided by PEER Interactive correlates with post-hoc demonstrated subject medication responsiveness. The research staff, in collaboration with the sponsor will also evaluate if the information provided by PEER Interactive results in improved mental health and/or a reduction of risk as measured by a reduction in Psychiatric Specific Adverse Events, including suicidality.
Essentially, there are two evaluations being made in this study. The first is an evaluation of the clinical utility of PEER Interactive where the health outcome of participants in the experimental group (those that receive information from PEER Interactive) will be compared to the outcomes of the control group (those subjects who did not receive information from PEER Interactive). The second is a validation of the PEER Interactive outcomes database which is intended to measure post-hoc the health outcomes of participants where the research staff's pharmacotherapy decisions agreed with the output of PEER Interactive. The chart below describes these evaluations.
Focus Method Endpoints Outcome database validation Post-hoc observational Mean effect in the Agreement vs. non-Agreement group Clinical utility Prospective randomized Mean effect in Experimental vs. Control group
A QEEG is required for this study. Therefore, all participants must be washed off medications for the QEEG. Though not standard clinical practice in all settings, this is a standard requirement of the QEEG process when a QEEG study is being performed to compare participant pathophysiology to a normative database composed of non-medicated participants.
The participants will be followed for not less than 6 months after the initial treatment, or until the subject has achieved maximum medical improvement (MMI). Determination of MMI is made retrospectively e.g. we can only determine that a participant has achieved MMI following that participant's demonstration of stability on medication/in treatment as evaluated across at least two visits for example: the participant is not getting better/has stabilized and will, in the judgment of the clinician, not get better. The participant will be seen on a routine basis and assessments will be made at each interaction to evaluate the participant's improvement in mental health. The participants will be closely evaluated to determine if they are experiencing any psychiatric specific adverse events. The research staff is allowed to treat the participant according to their best medical judgment, which may include adding or changing medications, seeing the participant more frequently, or other interventions. Clinicians will be encouraged to use their best clinical judgment and best clinical practice guidelines to assess the need for transition to a new medication. All interactions and interventions will be recorded in the case report form (CRF). A second QEEG will be administered at the final/study termination visit. This second QEEG will allow for analysis to indicate treatment-related changes to the QEEG. An additional analysis will be performed to identify changes that might indicate suicidal ideation (Hunter, et al. 2010 and Iosifescu, et al. 2008). This information will be compared with findings from the participant's CHRT-SR7 questionnaires.
- Conditions
- Depression
- Being tested
- EEG
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEGDevice
PEER EEG
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | EEG-guided drug prescription Receives: Device: EEG |
| Control | No intervention | Will receive EEG, but drugs will be prescribed as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16)
Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16) is a 16-item depressive symptomatology self-report questionnaires which has been useful as a way of determining a patient's level of depression before, during, and after treatment. Questions are answered by checking off the most appropriate answer to describe how they have been feeling over the past 7 days and are scored between 0-3 points per question.
Total score can range from 0-27 with higher values indicating worse outcomes (5 or lower: no depression, 6 to 10: mild depression, 11 to 15: moderate depression, 16 to 20: severe depression, 21 or higher: very severe depression).
The QIDS is score as follows: Sum together the highest score out of Items 1-4, Item 5 score, highest score out of Items 6-9, sum Item 10, 11, 12, 13, and 14, highest score out of Items 15 and 16, sum all of these values for the final total score.
Measured: Change from Baseline to 12 weeks to monitor change in depressive symptomatology.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study startFeb 2016
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A receives treatment as usual (TAU); Group B receives access to the PEER Report (technology under investigation)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Verner Knott, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620499
- Sponsor's protocol ID
- REB# 2015032
- Status last verified
- Nov 2020
- First submitted
- 29 Jan 2016
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Blinded, Randomized, Multicentre Study to Evaluate the Utility, Safety, and Efficacy of Using PEER Interactive to Inform the Prescription of Medications to Subjects With a Primary Diagnosis of a Depressive Disorder
- ClinicalTrials.gov ID
- NCT04620499
- Acronym / sponsor ID
- REB# 2015032
- Conditions
- Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 9 Nov 2020 (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.
Improving the prescription accuracy of psychotropic medications for military personnel diagnosed with neuropsychiatric disorders is imperative to promote accelerated treatment response and recovery. This study will determine whether PEER (Psychiatric EEG Evaluation Registry) Interactive (a comparison of a quantitative electroencephalogram (QEEG) to an existing database of subject outcomes) provides an objective adjunctive tool that is more effective in guiding treatment than the current standard of practice in the treatment of military personnel suffering from non-psychotic mental illness. For this prospective, multicenter, randomized, single-blinded, controlled study, 100 participants with a primary diagnosis of a DSM-V depressive disorder, with comorbidity of non-psychotic behavioral disorders to include mild Traumatic Brain Injury (mTBI) and Post Traumatic Stress Disorder (PTSD), will be enrolled. Participants will be randomized into a control or experimental group, and all will undergo a quantitative electroencephalogram (QEEG). For the experimental group, research staff will receive an Outcome Report from PEER Interactive and will follow the guidance of the Report to inform treatment. For the control group, research staff will not receive a participant Outcome Report from PEER Interactive and these participants will be treated based on current standards. For the control group, Outcome Reports will be sequestered for post-hoc analysis. Research staff in collaboration with CNS Response (the Sponsor) will evaluate and validate if the guidance provided by PEER Interactive correlates with the predicted participant outcome. Research staff in collaboration with the Sponsor will also evaluate if the treatment guidance provided by PEER Interactive results in improved mental health and/or a reduction of risk as measured by a reduction in severe adverse events, including suicidality.
Detailed description
Study Design
This is a prospective, single-blinded, randomized, multicenter study to evaluate the utility, safety, and efficacy of using PEER Interactive to inform the prescription of medications to participants with a primary diagnosis of a depressive disorder, with or without comorbidity of non-psychotic behavioral disorders, versus treatment as usual.
This study is observational in nature, in that the participants in the control group will be treated according to treatment as usual and best judgment of the treating clinician. The participants in the experimental group will be treated with adjunctive information provided by the PEER Interactive Report. It is a controlled study in that the schedule of visits, procedures and measurements will be defined by the protocol in order to provide consistent data for both the control and experimental groups.
Participants will be blinded as to presence/use of the PEER Interactive Report and will provide the primary efficacy outcome evaluation. All participants will be randomized into a control or experimental group. All participants will receive a quantitative electroencephalogram (QEEG). For those participants in the experimental group, the research staff will receive an Outcome Report from PEER Interactive. The clinician in the experimental group will use the PEER Interactive Report in the medication prescription process. For the control group, the research staff will not receive an Outcome Report. Outcome Reports for the control group will be sequestered for post-hoc analysis.
The research staff will incorporate the information provided by the Outcome Report from PEER Interactive in their prescription decisions. PEER Interactive provides adjunctive information to assist the treating clinician in the clinical decision process. For the experimental group the research staff is expected to follow the guidance of the subject's PEER Outcome Report as regards to the participant's responsiveness to the on-label medications noted in the Report. Although the study staff is strongly encouraged to use the guidance in the medication decision, prescription of medication is a clinical decision and will be made by the research staff. A decision to not follow the guidance of the Report should be documented and explained. In some cases, the Report may indicate sensitivity for a medication to which the subject has not been responsive in previous treatment - or - if effective for the diagnosed condition may cause/have caused an undesired side effect e.g. rash, nausea, etc. The clinician must always consider subject history in the treatment decision. We expect the Report will indicate that the participant will not be responsive to the previous treatment, and therefore, the treatment should not be prescribed. The PEER Report informs medication decisions as a part of treatment. If the only medication indicated by the report is a medication the participant has had poor experience with; the participant should be treated with another medication indicated as responsive by the Report. In the event the Report indicates the participant is not responsive to any of the on-label medications in the Report, the treating clinician may prescribe according to best clinical judgment. The research staff will note the basis for all medication decisions in the subject's treatment/study file. The only change to standard of care is the use of the PEER Report to inform medication decisions for the experimental group e.g. If a participant is receiving psychotherapy/ counseling along with medical therapy prior to enrollment, the participant will continue with all other therapies as usual.
Following the guidance of the PEER Outcome Report means prescribing any medication the report indicates the subject would be responsive to and not prescribing medications the report indicates the subject would not be responsive to. The PEER Outcome Report should be followed for up to two 'medication trials' to be considered as following the guidance of the report. A 'medication trial' is defined as prescribing a new medication to treat the subject. This includes augmentation and/or switching to a different medication. Dosing adjustments are not considered a medication trial.
The research staff, in collaboration with the sponsor, will evaluate and validate how closely the information provided by PEER Interactive correlates with post-hoc demonstrated subject medication responsiveness. The research staff, in collaboration with the sponsor will also evaluate if the information provided by PEER Interactive results in improved mental health and/or a reduction of risk as measured by a reduction in Psychiatric Specific Adverse Events, including suicidality.
Essentially, there are two evaluations being made in this study. The first is an evaluation of the clinical utility of PEER Interactive where the health outcome of participants in the experimental group (those that receive information from PEER Interactive) will be compared to the outcomes of the control group (those subjects who did not receive information from PEER Interactive). The second is a validation of the PEER Interactive outcomes database which is intended to measure post-hoc the health outcomes of participants where the research staff's pharmacotherapy decisions agreed with the output of PEER Interactive. The chart below describes these evaluations.
Focus Method Endpoints Outcome database validation Post-hoc observational Mean effect in the Agreement vs. non-Agreement group Clinical utility Prospective randomized Mean effect in Experimental vs. Control group
A QEEG is required for this study. Therefore, all participants must be washed off medications for the QEEG. Though not standard clinical practice in all settings, this is a standard requirement of the QEEG process when a QEEG study is being performed to compare participant pathophysiology to a normative database composed of non-medicated participants.
The participants will be followed for not less than 6 months after the initial treatment, or until the subject has achieved maximum medical improvement (MMI). Determination of MMI is made retrospectively e.g. we can only determine that a participant has achieved MMI following that participant's demonstration of stability on medication/in treatment as evaluated across at least two visits for example: the participant is not getting better/has stabilized and will, in the judgment of the clinician, not get better. The participant will be seen on a routine basis and assessments will be made at each interaction to evaluate the participant's improvement in mental health. The participants will be closely evaluated to determine if they are experiencing any psychiatric specific adverse events. The research staff is allowed to treat the participant according to their best medical judgment, which may include adding or changing medications, seeing the participant more frequently, or other interventions. Clinicians will be encouraged to use their best clinical judgment and best clinical practice guidelines to assess the need for transition to a new medication. All interactions and interventions will be recorded in the case report form (CRF). A second QEEG will be administered at the final/study termination visit. This second QEEG will allow for analysis to indicate treatment-related changes to the QEEG. An additional analysis will be performed to identify changes that might indicate suicidal ideation (Hunter, et al. 2010 and Iosifescu, et al. 2008). This information will be compared with findings from the participant's CHRT-SR7 questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Group A receives treatment as usual (TAU); Group B receives access to the PEER Report (technology under investigation)
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: EEGEEG-guided drug prescription |
| Control | No intervention | –Will receive EEG, but drugs will be prescribed as usual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female subjects between the ages of 18 - 65 years of age or older who speak and read English.
- Participants able to provide written informed consent to participate in the study.
- Participants with a primary diagnosis of a DSM-V depressive disorder, including subjects with comorbidity of a non-psychotic behavioral disorder.
- Participants with comorbidity of mild traumatic brain injury (mTBI) are eligible for inclusion in this study. mTBI will be defined according to best clinical practice guidelines. The subject should have experienced no more than 30 minutes of loss of consciousness, less than a 24 hour alteration in consciousness or mental status, less than 24 hours of post-traumatic amnesia and a Glasgow Coma Scale (best available score in the first 24 hours) of 13 or greater.
- Participants with comorbidity of post-traumatic stress disorder (PTSD) are eligible for inclusion in this study. A score of 45 or greater on the PTSD Checklist Military/Civilian (PCL-M/C) measurement tool will qualify a subject for inclusion of diagnosis of PTSD as a comorbid condition.
Key exclusion criteria (16 listed)
- Male and female subject less than 18 years old or greater than 65 years old
- Participants who cannot provide written informed consent
- Diagnosis of a psychotic disorder.
- History of, or current, open head brain trauma.
- Subjects with comorbidity of mild traumatic brain injury (mTBI) or traumatic brain injury (TBI) who experienced greater than 30 minutes loss of consciousness, greater than 24 hour alteration in consciousness or mental status, greater than 24 hours of post traumatic amnesia, or a Glasgow Coma Scale (best available score in first 24 hours) of less than 13.
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 |
|---|---|---|
| EEGPEER EEG | Device | Experimental |
Primary outcome
Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16)
Time frame: Change from Baseline to 12 weeks to monitor change in depressive symptomatology.
Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16) is a 16-item depressive symptomatology self-report questionnaires which has been useful as a way of determining a patient's level of depression before, during, and after treatment. Questions are answered by checking off the most appropriate answer to describe how they have been feeling over the past 7 days and are scored between 0-3 points per question. Total score can range from 0-27 with higher values indicating worse outcomes (5 or lower: no depression, 6 to 10: mild depression, 11 to 15: moderate depression, 16 to 20: severe depression, 21 or higher: very severe depression). The QIDS is score as follows: Sum together the highest score out of Items 1-4, Item 5 score, highest score out of Items 6-9, sum Item 10, 11, 12, 13, and 14, highest score out of Items 15 and 16, sum all of these values for the final total score.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Individual participant dataSharing planned: Yes
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EEG in people with Depression, run by University of Ottawa at 2 sites 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 16 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 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16) (time frame: Change from Baseline to 12 weeks to monitor change in depressive symptomatology.). 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 9 Nov 2020.