Sequence Towards Remission in Depression

NCT01628783 | Unknown Phase 4

• 1 other identifier: 2012-002476-14
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Montgomery-Åsberg rating scale

  7 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Microgranular cellulose in gelatine capsules.

Drug: Placebo

Escitalopram 10 mg

EXPERIMENTAL

Escitalopram in gelatine capsule

Drug: escitalopram 10 mg

Interventions

escitalopram 10 mg DRUG

orally once daily

Escitalopram 10 mg

Placebo DRUG

once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jesper Ekelund: lead
• Academy of Finland: collaborator

Study Sites (1)

Helsinki University Central Hospital, Psychiatry Centre

Helsinki, 00029, Finland

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Erkki Isometsä, MD-PhD

  University of Helsinki

  PRINCIPAL INVESTIGATOR

• Jesper Ekelund, MD-PhD

  University of Helsinki

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesper Ekelund, MD-PhD

CONTACT

+358503317987; Jesper.Ekelund@helsinki.fi

Erkki Isometsa, MD-PhD

CONTACT

+35894711; Erkki.Isometsa@helsinki.fi

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: June 24, 2012
• First Posted: June 27, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: October 1, 2015
• Last Updated: June 27, 2012

Record last verified: 2012-06

Locations

FI (1)