DepressionPhase 4STRIDENCT01628783
Sequence Towards Remission in Depression
A Phase 4 study testing escitalopram 10 mg in people with Depression, run by Jesper Ekelund at 1 site in Finland.
Trial summary
In this study the investigators use clinical, biological and imaging markers to develop predictive markers for remission from depression. The investigators compare individuals who have received placebo to individuals who have received 10 mg of escitalopram for one week. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression
- What is being tested?
- escitalopram 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteFinland
- Study dates
- Jun 2012to Oct 2015
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Major depressive disorder with current major depressive episode according to a SCID-I/P interview
- Montgomery-Åsberg depression rating score 15-30
- Age 18-60
Who cannot join
- Borderline, schizoid or schizotypal personality, bipolar or any psychotic disorder
- Primary diagnosis is anxiety disorder: 300.00, .01, .02, .21, .22, .29, .23, .3, 309.81, 308.3, 293.89
- Significant current suicidal ideation, or history of a suicide attempt
- Lifetime substance dependence; Last-year substance abuse; Last month over 24/16 standard doses of alcohol/week; Lifetime use of illicit substances > x5; Any illicit substance use in last month
- Depressive disorder due to medical condition or chemical substance
- Antidepressant medication use in last 4 months
- Severe, unstable somatic illness
- Use of antipsychotics, mood stabilizers, systemic corticosteroids, β-blockers or daytime benzodiazepines (a small dose of ≤10mg zolpidem once daily is permissible)
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Helsinki University Central Hospital, Psychiatry Centre
Helsinki, 00029
Jesper Ekelund, MD-PhD, +358503317987, Jesper.Ekelund@helsinki.fi
Emma Komulainen, MD, +358465260387, Emma.Komulainen@helsinki.fi
About this study
In this study the investigators use clinical, biological and imaging markers to develop predictive markers for remission from depression. The investigators compare individuals who have received placebo to individuals who have received 10 mg of escitalopram for one week. In this double-blind, randomized study the investigators a) compare the groups to observe the short-term effects of escitalopram and b) study the predictive value of these observations with respect to remission. Measures include, but are not restricted to, limbic emotional reactivity as assessed by fMRI, emotional processing, emotional memory, autobiographical memory.
- Conditions
- Depression
- Being tested
- escitalopram 10 mg, Placebo
- Keywords
- Depression, emotional processing, fMRI, autobiographic memory, moderator of treatment response, mediator of treatment response
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
escitalopram 10 mgDrug
orally once daily
PlaceboDrug
once daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Microgranular cellulose in gelatine capsules. Receives: Drug: Placebo |
| Escitalopram 10 mg | Experimental | Escitalopram in gelatine capsule Receives: Drug: escitalopram 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Åsberg rating scale
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2014 (estimated)
- Study completionOct 2015 (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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jesper Ekelund
- Sponsor type
- University, hospital or other
- Collaborators
- Academy of Finland
- Responsible party
- Sponsor-investigator, Jesper Ekelund, University of Helsinki
- Investigators
- Erkki Isometsä, MD-PhD, Principal investigator, University of HelsinkiJesper Ekelund, MD-PhD, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628783
- Sponsor's protocol ID
- 2012-002476-14
- Acronym
- STRIDE
- Status last verified
- Jun 2012
- First submitted
- 24 Jun 2012
- Last updated
- 27 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequence Towards Remission in Depression
- ClinicalTrials.gov ID
- NCT01628783
- Acronym / sponsor ID
- STRIDE / 2012-002476-14
- Conditions
- Depression
- Keywords
- Depression, emotional processing, fMRI, autobiographic memory, moderator of treatment response, mediator of treatment response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Jesper EkelundUniversity, hospital or other
- Collaborators
- Academy of Finland
- Study start
- Jun 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 27 Jun 2012 (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.
In this study the investigators use clinical, biological and imaging markers to develop predictive markers for remission from depression. The investigators compare individuals who have received placebo to individuals who have received 10 mg of escitalopram for one week. In this double-blind, randomized study the investigators a) compare the groups to observe the short-term effects of escitalopram and b) study the predictive value of these observations with respect to remission. Measures include, but are not restricted to, limbic emotional reactivity as assessed by fMRI, emotional processing, emotional memory, autobiographical memory.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboMicrogranular cellulose in gelatine capsules. |
| Escitalopram 10 mg | Experimental | Drug: escitalopram 10 mgEscitalopram in gelatine capsule |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Major depressive disorder with current major depressive episode according to a SCID-I/P interview
- Montgomery-Åsberg depression rating score 15-30
- Age 18-60
Key exclusion criteria (8 listed)
- Borderline, schizoid or schizotypal personality, bipolar or any psychotic disorder
- Primary diagnosis is anxiety disorder: 300.00, .01, .02, .21, .22, .29, .23, .3, 309.81, 308.3, 293.89
- Significant current suicidal ideation, or history of a suicide attempt
- Lifetime substance dependence; Last-year substance abuse; Last month over 24/16 standard doses of alcohol/week; Lifetime use of illicit substances > x5; Any illicit substance use in last month
- Depressive disorder due to medical condition or chemical substance
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 |
|---|---|---|
| escitalopram 10 mgorally once daily | Drug | Escitalopram 10 mg |
| Placeboonce daily | Drug | Placebo |
Primary outcome
Montgomery-Åsberg rating scale
Time frame: 7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2012.
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Survivorship
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.
Erkki Isometsä, MD-PhD principal investigator
University of Helsinki
Jesper Ekelund, MD-PhD principal investigator
University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing escitalopram 10 mg in people with Depression, run by Jesper Ekelund at 1 site in Finland.
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 8 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 27 Jun 2012. 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 Finland. 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.
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?
Contact Jesper Ekelund, MD-PhD (+358503317987, Jesper.Ekelund@helsinki.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Åsberg rating scale (time frame: 7 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 27 Jun 2012.