Sequence Towards Remission in Depression (STRIDE)

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.

Study Overview

• Status: Unknown
• Conditions: Depression
• Intervention / Treatment: Drug: Placebo; Drug: escitalopram 10 mg

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jesper Ekelund, MD-PhD; Phone Number: +358503317987; Email: Jesper.Ekelund@helsinki.fi
• Study Contact Backup: Name: Erkki Isometsa, MD-PhD; Phone Number: +35894711; Email: Erkki.Isometsa@helsinki.fi

Study Locations

• Finland
  • Helsinki, Finland, 00029
    • Recruiting
    • Helsinki University Central Hospital, Psychiatry Centre
    • Contact: Jesper Ekelund, MD-PhD; Phone Number: +358503317987; Email: Jesper.Ekelund@helsinki.fi
    • Contact: Emma Komulainen, MD; Phone Number: +358465260387; Email: Emma.Komulainen@helsinki.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Montgomery-Åsberg rating scale	7 weeks

Collaborators and Investigators

• Sponsor: Jesper Ekelund
• Collaborators: Academy of Finland
• Investigators: Principal Investigator: Erkki Isometsä, MD-PhD, University of Helsinki; Principal Investigator: Jesper Ekelund, MD-PhD, University of Helsinki

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ANTICIPATED): December 1, 2014
• Study Completion (ANTICIPATED): October 1, 2015

Study Registration Dates

• First Submitted: June 24, 2012
• First Submitted That Met QC Criteria: June 26, 2012
• First Posted (ESTIMATE): June 27, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): June 27, 2012
• Last Update Submitted That Met QC Criteria: June 26, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Depression; fMRI; emotional processing; autobiographic memory; moderator of treatment response; mediator of treatment response
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: 2012-002476-14