CClinicalTrials.gg
CompletedNCT02398877Cort-MetabUpdated Mar 7, 2016

HPA Axis Activity Due To Early Traumatic Stress and Metabolic Symptoms

An interventional study of stress in Childhood Trauma and Major Depressive Disorder, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-07.

Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
Female
01

Study summary

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

Read the detailed description

Early traumatic stress is associated with alterations of the hypothalamic-pituitary-adrenal axis (HPA-axis) indicated by an increased response to stress, a diminished negative feedback and alterations in expression of glucocorticoid receptors. Patients with a history of childhood trauma are more likely to develop metabolic disorders such as diabetes mellitus type 2 or metabolic syndrome.

The investigators will examine participants with and without early life stress and with and without major depression. The investigators assume that traumatized study participants (1) show an increased endocrine stress reaction to psychosocial stress, (2) display an altered sensitivity of GR, and (3) therefore suffer from an adverse cardiovascular risk profile in comparison to not-traumatized participants.

The investigators study will increase current knowledge on possible sequel of early traumatic stress. The results will lead to a more comprehensive understanding of stress-related eating behaviour and its implications.

02

Conditions studied

  • Childhood Trauma
  • Major Depressive Disorder
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 140 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • diagnosis of MDD and/or experience of early trauma

Exclusion criteria

Exclusion Criteria:

  • severe illness,
  • control group: no diagnosis of MDD and experience of early trauma
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
140 participants (actual)

Study arms

  • Experimental
    Depression with early trauma

    stress

    Other: stress

  • Experimental
    Depression without early trauma

    stress

    Other: stress

  • Experimental
    Healthy with early trauma

    stress

    Other: stress

  • Experimental
    Healthy without early trauma

    stress

    Other: stress

Interventions

  • Otherstress
06

What researchers measure

Primary outcomes

  1. Endocrine response to stress (salivary cortisol)

    salivary cortisol

    Time frame: 2 hours

  2. glucose to oral glucose tolerance test (plasma insulin)

    plasma glucose

    Time frame: 2 hours

  3. insulin to oral glucose tolerance test (plasma insulin)

    plasma insulin

    Time frame: 2 hours

  4. cortisol to corticotropin releasing factor (salivary cortisol)

    salivary cortisol

    Time frame: 3 hours

07

Study locations

1 site
  • Charite University
    Berlin, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02398877
Lead sponsor
Charite University, Berlin, Germany
Responsible party
Katja Wingenfeld (Head: Clinical Psychology, Charite University, Berlin, Germany) — Principal investigator
First posted
Mar 26, 2015
Start date
Feb 2013
Primary completion
Feb 2016
Completion
Feb 2016
Last update
Mar 7, 2016

Study contacts

Katja Wingenfeld, PhD
principal investigator · Charite University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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