Cytokine-Induced Transcription in Depressed Inpatients Undergoing Psychotherapy

Depression Clinical Trial

— CitDip  

Official title:

Cytokine-Induced Transcription in Depressed Inpatients Undergoing Psychotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06388486
• Other study ID #: UMCGoettingen9/9/16
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: January 1, 2024

Study information

• Verified date: April 2024
• Source: University Medical Center Goettingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: January 1, 2024
• Est. primary completion date: March 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression

Intervention

Behavioral:
• Psychotherapy
Subject receive psychotherapy during hospital treatment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Goettingen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in depression	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.	6 weeks