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Clinical Trials/NCT01628783
NCT01628783
Unknown
Phase 4

Sequence Towards Remission in Depression

Jesper Ekelund1 site in 1 country90 target enrollmentJune 2012

Overview

Phase
Phase 4
Intervention
Placebo
Conditions
Depression
Sponsor
Jesper Ekelund
Enrollment
90
Locations
1
Primary Endpoint
Montgomery-Åsberg rating scale
Last Updated
13 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
June 2012
End Date
October 2015
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Jesper Ekelund
Responsible Party
Sponsor Investigator
Principal Investigator

Jesper Ekelund

Professor of Psychiatry

University of Helsinki

Eligibility Criteria

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)

Arms & Interventions

Placebo

Microgranular cellulose in gelatine capsules.

Intervention: Placebo

Escitalopram 10 mg

Escitalopram in gelatine capsule

Intervention: escitalopram 10 mg

Outcomes

Primary Outcomes

Montgomery-Åsberg rating scale

Time Frame: 7 weeks

Study Sites (1)

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