Sequence Towards Remission in Depression (STRIDE)

This study is currently recruiting participants.
Verified June 2012 by Helsinki University
Sponsor:
Collaborator:
Academy of Finland
Information provided by (Responsible Party):
Jesper Ekelund, Helsinki University
ClinicalTrials.gov Identifier:
NCT01628783
First received: June 24, 2012
Last updated: June 26, 2012
Last verified: June 2012

June 24, 2012
June 26, 2012
June 2012
December 2014   (final data collection date for primary outcome measure)
Montgomery-Åsberg rating scale [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01628783 on ClinicalTrials.gov Archive Site
 
 
 
 
 
Sequence Towards Remission in Depression
Sequence Towards Remission in Depression

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.

 
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Depression
  • Drug: escitalopram 10 mg
    orally once daily
  • Drug: Placebo
    once daily
  • Placebo Comparator: Placebo
    Microgranular cellulose in gelatine capsules.
    Intervention: Drug: Placebo
  • Experimental: Escitalopram 10 mg
    Escitalopram in gelatine capsule
    Intervention: Drug: escitalopram 10 mg
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
October 2015
December 2014   (final data collection date for primary outcome measure)

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, β-blockers or daytime benzodiazepines (a small dose of ≤10mg zolpidem once daily is permissible)
Both
18 Years to 60 Years
No
Contact: Jesper Ekelund, MD-PhD +358503317987 Jesper.Ekelund@helsinki.fi
Contact: Erkki Isometsa, MD-PhD +35894711 Erkki.Isometsa@helsinki.fi
Finland
 
NCT01628783
2012-002476-14
No
Jesper Ekelund, Helsinki University
Jesper Ekelund
Academy of Finland
Principal Investigator: Erkki Isometsä, MD-PhD Helsinki University
Principal Investigator: Jesper Ekelund, MD-PhD Helsinki University
Helsinki University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP