HPA Axis Activity Due To Early Traumatic Stress and Metabolic Symptoms

NCT ID: NCT02398877

Last Updated: 2016-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2016-02-29

Brief Summary

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

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.

Conditions

Childhood Trauma; Major Depressive Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Depression with early trauma

stress

Group Type: EXPERIMENTAL

stress

Intervention Type: OTHER

Depression without early trauma

stress

Group Type: EXPERIMENTAL

stress

Intervention Type: OTHER

Healthy with early trauma

stress

Group Type: EXPERIMENTAL

stress

Intervention Type: OTHER

Healthy without early trauma

stress

Group Type: EXPERIMENTAL

stress

Intervention Type: OTHER

Interventions

stress

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• diagnosis of MDD and/or experience of early trauma

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Katja Wingenfeld

Head: Clinical Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katja Wingenfeld, PhD

Role: PRINCIPAL_INVESTIGATOR

Charite University

Locations

Charite University

Berlin, , Germany

Countries

Germany

Other Identifiers

WI 3396/6-1

Identifier Type: -

Identifier Source: org_study_id