DepressionNCT00924183
Measuring Response to Depression Treatment
An observational study of Depression, run by Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc. at 1 site in Canada.
Trial summary
The primary goal of this study is to compare a new symptoms rating questionnaire, called the Vancouver Semi-Structured Interview for Depression (V-SID), to the traditionally used questionnaires. The investigators predict that the V-SID will be more sensitive to patients' improvement than are traditional questionnaires. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Treatment-as-usual
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2008to Jul 2011
- Phase
- Observational
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All subjects will diagnosed with a current major depressive episode. They will be recruited from a community healthcare centre.
Who may be able to join
- Major depressive episode, diagnosed using the Mini-International Neuropsychiatric Interview (MINI)
- Depression not currently effectively treated
- Age 19 to 65 years
Who cannot join
- Co-morbid Axis I disorders (co-morbid anxiety symptoms, including generalized anxiety or panic attacks, are not exclusionary if they are present in the context of a primary mood disorder)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measuring Response to Depression Treatment: A Study Comparing the Sensitivity of Multiple Outcome Measures to Change
The primary goal of this study is to compare a new symptoms rating questionnaire, called the Vancouver Semi-Structured Interview for Depression (V-SID), to the traditionally used questionnaires. The investigators predict that the V-SID will be more sensitive to patients' improvement than are traditional questionnaires.
Read the detailed description
Depression is sometimes associated with difficulties in thinking skills. Recent evidence suggests that in those people who have thinking difficulties, effective treatment and improvement of depression can also result in improved thinking skills. Therefore, a test of thinking skills is included in this study.
This study will also evaluate three other potential indicators of treatment response: cortisol, cytokines, and grip strength.
- Conditions
- Depression
- Being tested
- Treatment-as-usual
- Keywords
- Depression, Symptom scales, Symptom measures, Vancouver Semi-Structured Interview for Depression, V-SID, VSID, treatment-as-usual, treatment as usual, open-label, open label, Major Depressive Episode, MDE
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment-as-usualOther
| Study group | Role | What they receive |
|---|---|---|
| Treatment-as-usual | All patients will receive treatment as usual: antidepressant medication and/or cognitive behavioral therapy (CBT). Patients' results will be compare to their own baseline measurements. Receives: Other: Treatment-as-usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression (HAM-D)
Measured: Pre-Baseline, Day 0, Week 1, Week 4, Week 8
Vancouver Semi-Structured Interview for Depression (V-SID)
Measured: Pre-Baseline, Day 0, Week 1, Week 4, Week 8
Montgomery-Asberg Depression Rating Scale (MADRS)
Measured: Pre-Baseline, Day 0, Week 1, Week 4, Week 8
Clinical Global Impression
Measured: Pre-Baseline, Day 0, Week 1, Week 4, Week 8, Followup
Hamilton Rating Scale for Anxiety (HAM-A)
Measured: Pre-Baseline, Day 0, Week 1, Week 4, Week 8
British Columbia Major Depression Inventory (BC-MDI)
Measured: Pre-Baseline, Day 0, Week 1, Week 4, Week 8
Quality of Life Enjoyment Satisfaction Questionnaire (Q-LES-Q)
Measured: Day 0, Week 8
Secondary outcomes (6)
CNS Vital Signs
Measured: Pre-Baseline, Day 0, Week 8
British Columbia Cognitive Complaints Inventory (BC-CCI)
Measured: Pre-Baseline, Day 0, Week 1, Week 4, Week 8
Grip strength
Measured: Pre-Baseline, Day 0, Week 8
Cortisol level
Measured: Day 0, Week 8
Neuroimmunobiologic markers
Measured: Pre-Baseline, Week 8
Evaluation for Metabolic Syndrome
Measured: Day 0, Week 8, Followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study startJun 2008
- Primary completionJul 2011 (estimated)
- Study completionJul 2011 (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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Investigators
- Diane McIntosh, MD, FRCPC, Principal investigator, Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924183
- Sponsor's protocol ID
- D1443L00014
- Status last verified
- Mar 2011
- First submitted
- 10 Jun 2009
- Last updated
- 23 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Response to Depression Treatment: A Study Comparing the Sensitivity of Multiple Outcome Measures to Change
- ClinicalTrials.gov ID
- NCT00924183
- Acronym / sponsor ID
- D1443L00014
- Conditions
- Depression
- Keywords
- Depression, Symptom scales, Symptom measures, Vancouver Semi-Structured Interview for Depression, V-SID, VSID, treatment-as-usual, treatment as usual
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.University, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Jun 2008
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 18 Jun 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 primary goal of this study is to compare a new symptoms rating questionnaire, called the Vancouver Semi-Structured Interview for Depression (V-SID), to the traditionally used questionnaires. The investigators predict that the V-SID will be more sensitive to patients' improvement than are traditional questionnaires.
Detailed description
Depression is sometimes associated with difficulties in thinking skills. Recent evidence suggests that in those people who have thinking difficulties, effective treatment and improvement of depression can also result in improved thinking skills. Therefore, a test of thinking skills is included in this study.
This study will also evaluate three other potential indicators of treatment response: cortisol, cytokines, and grip strength.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment-as-usual | – | Other: Treatment-as-usualAll patients will receive treatment as usual: antidepressant medication and/or cognitive behavioral therapy (CBT). Patients' results will be compare to their own baseline measurements. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects will diagnosed with a current major depressive episode. They will be recruited from a community healthcare centre.
Key inclusion criteria (3 listed)
- Major depressive episode, diagnosed using the Mini-International Neuropsychiatric Interview (MINI)
- Depression not currently effectively treated
- Age 19 to 65 years
Key exclusion criteria (1 listed)
- Co-morbid Axis I disorders (co-morbid anxiety symptoms, including generalized anxiety or panic attacks, are not exclusionary if they are present in the context of a primary mood disorder)
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 |
|---|---|---|
| Treatment-as-usual | Other | Treatment-as-usual |
Primary outcome
Hamilton Rating Scale for Depression (HAM-D)
Time frame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8
Vancouver Semi-Structured Interview for Depression (V-SID)
Time frame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8
Clinical Global Impression
Time frame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8, Followup
Hamilton Rating Scale for Anxiety (HAM-A)
Time frame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8
British Columbia Major Depression Inventory (BC-MDI)
Time frame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8
Quality of Life Enjoyment Satisfaction Questionnaire (Q-LES-Q)
Time frame: Day 0, Week 8
6 secondary outcomes
CNS Vital Signs
Time frame: Pre-Baseline, Day 0, Week 8
British Columbia Cognitive Complaints Inventory (BC-CCI)
Time frame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8
Grip strength
Time frame: Pre-Baseline, Day 0, Week 8
Cortisol level
Time frame: Day 0, Week 8
Neuroimmunobiologic markers
Time frame: Pre-Baseline, Week 8
Evaluation for Metabolic Syndrome
Time frame: Day 0, Week 8, Followup
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2011.
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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.
Diane McIntosh, MD, FRCPC principal investigator
Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc. 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 3 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: status not confirmed, as of the sponsor's last update on 23 Mar 2011. 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?
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?
Hamilton Rating Scale for Depression (HAM-D) (time frame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8). The study lists 7 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 23 Mar 2011.