Sequence Towards Remission in Depression (STRIDE)
This study is currently recruiting participants.
Verified June 2012 by Helsinki University
Sponsor:
Jesper Ekelund
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
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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
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 May 19, 2013