Sequence Towards Remission in Depression

Depression Clinical Trial

— STRIDE  

Official title:

Sequence Towards Remission in Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01628783
• Other study ID #: 2012-002476-14
• Status: Recruiting
• Phase: Phase 4
• First received: June 24, 2012
• Last updated: June 26, 2012
• Start date: June 2012
• Est. completion date: October 2015

Study information

• Verified date: June 2012
• Source: Helsinki University
• Contact: Jesper Ekelund, MD-PhD
• Phone: +358503317987
• Email: Jesper.Ekelund[@]helsinki.fi
• Is FDA regulated: No
• Health authority: Finland: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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, ß-blockers or daytime benzodiazepines (a small dose of =10mg zolpidem once daily is permissible)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• escitalopram 10 mg
orally once daily
• Placebo
once daily

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital, Psychiatry Centre	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
Jesper Ekelund	Academy of Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery-Åsberg rating scale		7 weeks	No