NCT02398877

Brief Summary

This study evaluates the association between early trauma, depression and metabolic symptoms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 7, 2016

Status Verified

March 1, 2016

Enrollment Period

3 years

First QC Date

March 9, 2015

Last Update Submit

March 4, 2016

Conditions

Childhood TraumaMajor Depressive Disorder

Outcome Measures

Primary Outcomes (4)

  • Endocrine response to stress (salivary cortisol)

    salivary cortisol

    2 hours

  • glucose to oral glucose tolerance test (plasma insulin)

    plasma glucose

    2 hours

  • insulin to oral glucose tolerance test (plasma insulin)

    plasma insulin

    2 hours

  • cortisol to corticotropin releasing factor (salivary cortisol)

    salivary cortisol

    3 hours

Study Arms (4)

Depression with early trauma

EXPERIMENTAL

stress

Other: stress

Depression without early trauma

EXPERIMENTAL

stress

Other: stress

Healthy with early trauma

EXPERIMENTAL

stress

Other: stress

Healthy without early trauma

EXPERIMENTAL

stress

Other: stress

Interventions

stressOTHER
Depression with early traumaDepression without early traumaHealthy with early traumaHealthy without early trauma

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • diagnosis of MDD and/or experience of early trauma

You may not qualify if:

  • severe illness,
  • control group: no diagnosis of MDD and experience of early trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite University

Berlin, Germany

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Katja Wingenfeld, PhD

    Charite University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head: Clinical Psychology

Study Record Dates

First Submitted

March 9, 2015

First Posted

March 26, 2015

Study Start

February 1, 2013

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

March 7, 2016

Record last verified: 2016-03

Locations

DE(1)