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Sequence Towards Remission in Depression (STRIDE)

Primary Purpose

Depression

Status

Unknown status

Phase

Phase 4

Locations

Finland

Study Type

Interventional

Intervention

escitalopram 10 mg

Placebo

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, emotional processing, fMRI, autobiographic memory, moderator of treatment response, mediator of treatment response

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Helsinki University Central Hospital, Psychiatry CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Escitalopram 10 mg

Arm Description

Microgranular cellulose in gelatine capsules.

Escitalopram in gelatine capsule

Outcomes

Primary Outcome Measures

Montgomery-Åsberg rating scale

Secondary Outcome Measures

Full Information

NCT ID

NCT01628783

First Posted

June 24, 2012

Last Updated

June 26, 2012

Sponsor

Jesper Ekelund

Collaborators

Academy of Finland

1. Study Identification

Unique Protocol Identification Number

NCT01628783

Brief Title

Sequence Towards Remission in Depression

Acronym

STRIDE

Official Title

Sequence Towards Remission in Depression

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Unknown status

Study Start Date

June 2012 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jesper Ekelund

Collaborators

Academy of Finland

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

Keywords

Depression, emotional processing, fMRI, autobiographic memory, moderator of treatment response, mediator of treatment response

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Microgranular cellulose in gelatine capsules.

Arm Title

Escitalopram 10 mg

Arm Type

Experimental

Arm Description

Escitalopram in gelatine capsule

Intervention Type

Drug

Intervention Name(s)

escitalopram 10 mg

Intervention Description

orally once daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

once daily

Primary Outcome Measure Information:

Title

Montgomery-Åsberg rating scale

Time Frame

7 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jesper Ekelund, MD-PhD

Phone

+358503317987

Jesper.Ekelund@helsinki.fi

First Name & Middle Initial & Last Name or Official Title & Degree

Erkki Isometsa, MD-PhD

Phone

+35894711

Erkki.Isometsa@helsinki.fi

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Erkki Isometsä, MD-PhD

Organizational Affiliation

University of Helsinki

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jesper Ekelund, MD-PhD

Organizational Affiliation

University of Helsinki

Official's Role

Principal Investigator

Facility Information:

Facility Name

Helsinki University Central Hospital, Psychiatry Centre

City

Helsinki

ZIP/Postal Code

00029

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jesper Ekelund, MD-PhD

Phone

+358503317987

Jesper.Ekelund@helsinki.fi

First Name & Middle Initial & Last Name & Degree

Emma Komulainen, MD

Phone

+358465260387

Emma.Komulainen@helsinki.fi

12. IPD Sharing Statement

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Sequence Towards Remission in Depression

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