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OpenTrials
Completed

NCT Number: NCT06388486

Cytokine-Induced Transcription in Depressed Inpatients Undergoing Psychotherapy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychotherapy

Behavioral

Subject receive psychotherapy during hospital treatment.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Medical Center Goettingen

Other

Registry information

Acronym: CitDip

Important dates

Study start
2017
Primary completion
2022
Study completion
2024
First posted
Apr 29, 2024
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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