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Clinical Trials/NCT06388486
NCT06388486CompletedNot Applicable

Cytokine-Induced Transcription in Depressed Inpatients Undergoing Psychotherapy

University Medical Center Goettingen0 sites63 target enrollmentStarted: January 1, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
63
Primary Endpoint
Change in depression

Study Overview

Brief Summary

The goal of this observational study is to measure the levels of cytokine-induced transcription factor activation in a cohort of depressed inpatients undergoing psychotherapy. The study aims to answer the following main questions:

  • Do psychological traits (i.e.: social inhibition, negative affectivity, ...) affect the activation of immunomodulatory transcription factors (STAT3, NFkB) in depressed patients?
  • Are subjects with these psychological traits affected differently by psychotherapeutic intervention?

Study subjects are assessed for their psychological and behavioral traits and receive psychotherapeutic care over several weeks during hospital treatment. Peripheral blood mononuclear cells are isolated from the study subjects, and activation of transcription factors is measured by flow cytometry.

Detailed Description

Study subjects are assessed for their psychological and behavioral traits and receive psychotherapeutic care over several weeks during hospital treatment. Peripheral blood mononuclear cells are isolated from the study subjects, and activation of transcription factors is measured by flow cytometry.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of current depression

Exclusion Criteria

  • inadequate knowledge of the German language
  • unable to give informed consent
  • severe psychiatric comorbidities, such as drug abuse and psychotic diseases
  • deemed critically unstable by their treating physician

Outcomes

Primary Outcomes

Change in depression

Time Frame: 6 weeks

Hospital Depression and Anxiety Scale (HADS). The HADS instrument is a 14-item scale, with seven items relating to anxiety and seven relating to depression item. Each item on qestionnaire is scored from 0-3 resulting in a score between 0 and 21 for either anxiety or depression with higher scores meaning a worse outcome.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Medical Center Goettingen
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Prof. Thomas Meyer

Clinical Professor, Head of the Molecular Psychocardiology laboratory

University Medical Center Goettingen

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