Cytokine-Induced Transcription in Depressed Inpatients Un... | NCT06388486

Studies
Cytokine-Induced Transcription in Depressed Inpatients Undergoing Psychotherapy

NCT06388486

Sponsor

University Medical Center Goettingen

Status

Completed

Last Update Posted

Apr 30, 2024Actual

Enrollment

63Actual

Phase

Not provided

Conditions

Depression

Interventions

Psychotherapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Mar 9, 2022Actual

Completion Date

Jan 1, 2024Actual

First Submitted Date

Apr 23, 2024

First Submission Date that Met QC Criteria

Apr 23, 2024

First Posted Date

Apr 29, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2024

Last Update Posted Date

Apr 30, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Thomas Meyer, Clinical Professor, Head of the Molecular Psychocardiology laboratory, University Medical Center GoettingenPrincipal Investigator

Lead Sponsor

University Medical Center GoettingenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Psychotherapy	Behavioral	Subject receive psychotherapy during hospital treatment.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Depressed inpatients, admitted for multimodal treatment, including psychotherapy.

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011613	Psychotherapy

Ancestor Terms

ID	Term
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided