Sequence Towards Remission in Depression (STRIDE)

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention Phase
Depression
Drug: escitalopram 10 mg
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sequence Towards Remission in Depression

Resource links provided by NLM:


Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • Montgomery-Åsberg rating scale [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: June 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Microgranular cellulose in gelatine capsules.
Drug: Placebo
once daily
Experimental: Escitalopram 10 mg
Escitalopram in gelatine capsule
Drug: escitalopram 10 mg
orally once daily

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01628783

Contacts
Contact: Jesper Ekelund, MD-PhD +358503317987 Jesper.Ekelund@helsinki.fi
Contact: Erkki Isometsa, MD-PhD +35894711 Erkki.Isometsa@helsinki.fi

Locations
Finland
Helsinki University Central Hospital, Psychiatry Centre Recruiting
Helsinki, Finland, 00029
Contact: Jesper Ekelund, MD-PhD    +358503317987    Jesper.Ekelund@helsinki.fi   
Contact: Emma Komulainen, MD    +358465260387    Emma.Komulainen@helsinki.fi   
Sponsors and Collaborators
Jesper Ekelund
Academy of Finland
Investigators
Principal Investigator: Erkki Isometsä, MD-PhD Helsinki University
Principal Investigator: Jesper Ekelund, MD-PhD Helsinki University
  More Information

No publications provided

Responsible Party: Jesper Ekelund, Professor of Psychiatry, Helsinki University
ClinicalTrials.gov Identifier: NCT01628783     History of Changes
Other Study ID Numbers: 2012-002476-14
Study First Received: June 24, 2012
Last Updated: June 26, 2012
Health Authority: Finland: Institutional Review Board

Keywords provided by Helsinki University:
Depression
emotional processing
fMRI
autobiographic memory
moderator of treatment response
mediator of treatment response

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on July 26, 2014