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Sequence Towards Remission in Depression (STRIDE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Jesper Ekelund, Helsinki University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01628783
First Posted: June 27, 2012
Last Update Posted: June 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Academy of Finland
Information provided by (Responsible Party):
Jesper Ekelund, Helsinki University
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sequence Towards Remission in Depression

Resource links provided by NLM:


Further study details as provided by Jesper Ekelund, Helsinki University:

Primary Outcome Measures:
  • Montgomery-Åsberg rating scale [ Time Frame: 7 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jesper Ekelund, Professor of Psychiatry, Helsinki University
ClinicalTrials.gov Identifier: NCT01628783     History of Changes
Other Study ID Numbers: 2012-002476-14
First Submitted: June 24, 2012
First Posted: June 27, 2012
Last Update Posted: June 27, 2012
Last Verified: June 2012

Keywords provided by Jesper Ekelund, 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
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents