DepressionNCT00517764
Childhood Adversity, Genetic Polymorphisms and Stress in First Onset Major Depression
A study testing escitalopram in people with Depression, run by Centre for Addiction and Mental Health at 2 sites in Canada.
Trial summary
The Blue Sky Project, a 5-year study funded by the Canadian Institutes of Health Research, seeks to examine how genetics and early life experiences work together to cause a person's very first onset of depression by increasing sensitivity to stress. Read more about this study
- Who is it for?
- Ages 16 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- escitalopram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 2 sitesCanada
- Study dates
- Dec 2006to Jun 2013
- 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 16 to 29 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Current diagnosis of non-psychotic unipolar major depression; first onset
- Between 16 and 29 years of age
- Free of antidepressant treatment for a minimum of two weeks prior to treatment OR on an inadequate antidepressant treatment
- Minimum 8th grade education and fluency in reading English
- Live in the Kingston Area; willing to travel to the Queen's University for appointments
Who cannot join
- Diagnosis of previous episode(s) of major depression
- Past or present diagnosis of Bipolar Disorder, Schizoaffective Disorder, Schizophrenia, Substance Dependence Disorder, Borderline Personality Disorder, Anti-social Personality Disorder, or Organic Brain Syndrome
- Electroconvulsive Therapy in the past 6 months
- Concurrent serious medical illness judged to be contributing to the depression or impacting on treatment
- Presence of significant suicidal ideation
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Queens University
Kingston, Ontario, K7L 3N6
Centre for Addiction and Mental Health
Toronto, Ontario, M5T 1R8
About this study
Official title: The Role of Childhood Adversity and Genetic Polymorphisms in the Serotonin and Brain-Derived Neurotrophic Factor Systems in the Sensitization to Stress in First-Onset Major Depression (Blue Sky Project)
The Blue Sky Project, a 5-year study funded by the Canadian Institutes of Health Research, seeks to examine how genetics and early life experiences work together to cause a person's very first onset of depression by increasing sensitivity to stress.
Read the detailed description
Many forms of stress can precipitate an episode of depression. However, not everyone who experiences these sorts of stressors becomes depressed. Individuals with an at-risk genetic profile are more likely to get depressed in the face of stress, and require less severe levels of stress to get depressed, than individuals without this genetic profile. This model can help explain why young people get depressed the very first time. Young people with a particular variant of the serotonin transporter gene might require less severe levels of stress in both childhood and adulthood to precipitate their first episode of depression than individuals who do not possess this at-risk genetic variant. The current study involves 3 arms:
Participants at the Centre for Addiction and Mental Health site were enrolled in a 16-week trial of escitalopram (Lexapro/Cipralex), an established SSRI antidepressant that has been shown to be more effective and tolerable than other SSRIs. A psychiatrist and a trained research assistant will meet with participants every 2-3 weeks for the duration of the 16-week trial and participants will be asked to complete a number of standard psychological tests. After completion of the treatment phase, participants may continue into the follow-up phase involving monthly telephone contact and short appointments over an 18-month period. This arm of the study has finished and is no longer recruiting participants.
Participant at the Sunnybrook Health Sciences Centre site were enrolled in an assessment-only non-treatment arm. A research assistant met with participants to complete the same standard psychological tests as above. Participants received standard medical care from their attending psychiatrist. Participants may continue into the follow-up phase involving short appointments over an 18-month period to complete psychological assessments. This arm of the study has finished and is no longer recruiting participants.
Participant at the Queen's University site are enrolled in an assessment-only non-treatment arm. A research assistant will meet with participants to complete the same standard psychological tests as above. Participants will receive standard medical care from their attending psychiatrist or will be referred for treatment if they do not currently have a psychiatrist. Participants may continue into the follow-up phase involving short appointments over an 18-month period to complete psychological assessments.
- Conditions
- Depression
- Being tested
- escitalopram
- Keywords
- major depressive disorder, MDD, escitalopram, open-label, major depression, serotonin transporter, brain-derived neurotrophic factor
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
escitalopramDrug
Also called Lexapro, Cipralex, S-citalopram
Patients started on 20mg of escitalopram and this dose was increased based on tolerability and therapeutic response to a maximum dose of 40mg by week 12. The trial was 16 weeks. The treatment trial has completed and is no longer accepting patients.
| Study group | Role | What they receive |
|---|---|---|
| Healthy control | No intervention | Healthy matched control, no intervention |
| Escitalopram | Active comparator | Depressed subjects receiving escitalopram Receives: Drug: escitalopram |
| subjects with major depression | No intervention | Depressed subjects not receiving study treatment, but taking part in study measures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression (HRDS)
Measured: every 2-3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2007 (estimated)
- Study startDec 2006
- Primary completionJun 2013
- Study completionJun 2013
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.
- More trials run by Centre for Addiction and Mental HealthThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Queen's University
- Responsible party
- Principal investigator, Kate Harkness, Centre for Addiction and Mental Health
- Investigators
- Kate L Harkness, PhD, Principal investigator, Queens UniversityR.Michael Bagby, Ph.D., Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517764
- Sponsor's protocol ID
- 155/2006
- Status last verified
- Aug 2013
- First submitted
- 15 Aug 2007
- Last updated
- 9 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Childhood Adversity and Genetic Polymorphisms in the Serotonin and Brain-Derived Neurotrophic Factor Systems in the Sensitization to Stress in First-Onset Major Depression (Blue Sky Project)
- ClinicalTrials.gov ID
- NCT00517764
- Acronym / sponsor ID
- 155/2006
- Conditions
- Depression
- Keywords
- major depressive disorder, MDD, escitalopram, open-label, major depression, serotonin transporter, brain-derived neurotrophic factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Queen's University
- Study start
- Dec 2006
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 17 Aug 2007 (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 Blue Sky Project, a 5-year study funded by the Canadian Institutes of Health Research, seeks to examine how genetics and early life experiences work together to cause a person's very first onset of depression by increasing sensitivity to stress.
Detailed description
Many forms of stress can precipitate an episode of depression. However, not everyone who experiences these sorts of stressors becomes depressed. Individuals with an at-risk genetic profile are more likely to get depressed in the face of stress, and require less severe levels of stress to get depressed, than individuals without this genetic profile. This model can help explain why young people get depressed the very first time. Young people with a particular variant of the serotonin transporter gene might require less severe levels of stress in both childhood and adulthood to precipitate their first episode of depression than individuals who do not possess this at-risk genetic variant. The current study involves 3 arms:
Participants at the Centre for Addiction and Mental Health site were enrolled in a 16-week trial of escitalopram (Lexapro/Cipralex), an established SSRI antidepressant that has been shown to be more effective and tolerable than other SSRIs. A psychiatrist and a trained research assistant will meet with participants every 2-3 weeks for the duration of the 16-week trial and participants will be asked to complete a number of standard psychological tests. After completion of the treatment phase, participants may continue into the follow-up phase involving monthly telephone contact and short appointments over an 18-month period. This arm of the study has finished and is no longer recruiting participants.
Participant at the Sunnybrook Health Sciences Centre site were enrolled in an assessment-only non-treatment arm. A research assistant met with participants to complete the same standard psychological tests as above. Participants received standard medical care from their attending psychiatrist. Participants may continue into the follow-up phase involving short appointments over an 18-month period to complete psychological assessments. This arm of the study has finished and is no longer recruiting participants.
Participant at the Queen's University site are enrolled in an assessment-only non-treatment arm. A research assistant will meet with participants to complete the same standard psychological tests as above. Participants will receive standard medical care from their attending psychiatrist or will be referred for treatment if they do not currently have a psychiatrist. Participants may continue into the follow-up phase involving short appointments over an 18-month period to complete psychological assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy control | No intervention | –Healthy matched control, no intervention |
| Escitalopram | Active comparator | Drug: escitalopramDepressed subjects receiving escitalopram |
| subjects with major depression | No intervention | –Depressed subjects not receiving study treatment, but taking part in study measures. |
Who may qualify
- Ages
- 16 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Current diagnosis of non-psychotic unipolar major depression; first onset
- Between 16 and 29 years of age
- Free of antidepressant treatment for a minimum of two weeks prior to treatment OR on an inadequate antidepressant treatment
- Minimum 8th grade education and fluency in reading English
- Live in the Kingston Area; willing to travel to the Queen's University for appointments
Key exclusion criteria (5 listed)
- Diagnosis of previous episode(s) of major depression
- Past or present diagnosis of Bipolar Disorder, Schizoaffective Disorder, Schizophrenia, Substance Dependence Disorder, Borderline Personality Disorder, Anti-social Personality Disorder, or Organic Brain Syndrome
- Electroconvulsive Therapy in the past 6 months
- Concurrent serious medical illness judged to be contributing to the depression or impacting on treatment
- Presence of significant suicidal ideation
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 |
|---|---|---|
| escitalopramAlso: Lexapro, Cipralex, S-citalopramPatients started on 20mg of escitalopram and this dose was increased based on tolerability and therapeutic response to a maximum dose of 40mg by week 12. The trial was 16 weeks. The treatment trial has completed and is no longer accepting patients. | Drug | Escitalopram |
Primary outcome
Hamilton Rating Scale for Depression (HRDS)
Time frame: every 2-3 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 9 Aug 2013.
- Information about research at the Centre for Addiction and Mental HealthLink provided by the sponsor.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
Kate L Harkness, PhD principal investigator
Queens University
R.Michael Bagby, Ph.D. principal investigator
Centre for Addiction and Mental Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing escitalopram in people with Depression, run by Centre for Addiction and Mental Health 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 5 inclusion and 5 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 9 Aug 2013. 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.
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?
Hamilton Rating Scale for Depression (HRDS) (time frame: every 2-3 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 9 Aug 2013.