NCT07771517

Brief Summary

This is a case control study including simple random cases of 90 persons, 45 of them have depressive disorders and the other 45 are healthy individuals,age group between 18-60 years old, cases will be recruited from outpatient psychiatric clinic in sohag university hospital, all cases will be exposed to psychological assessment and also laboratory assessment of kynurenine metabolites by using biokits

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
27mo left

Started Mar 2027

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 18, 2026

Completed
7 months until next milestone

Study Start

First participant enrolled

March 14, 2027

Expected
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2028

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2029

Last Updated

August 20, 2026

Status Verified

August 1, 2026

Enrollment Period

1.4 years

First QC Date

August 3, 2026

Last Update Submit

August 18, 2026

Conditions

Keywords

Kynurenine pathwayMDDKynurenine pathway in depressive disordersDepressive disorderBipolar disorderRole of kynurenine pathway and its Metabolites in depressive disorders

Outcome Measures

Primary Outcomes (2)

  • Psychological assessment of patients with depressive disorders

    All cases will be subjected to psychological assessment by using structured clinical interview for DSM-V to assess major depressive disorder,bipolar and other depressivedisorders, Hamilton depression rating scale HAN-D to assess MDD, Hamilton anxiety inventory HAM-A to assess anxiety disorders, Montreal cognitive assessment to assess cognitive functions, Pittsburg sleep quality index to assess quality of sleep and detailed family history will be obtained to assess possibility of genetic factors in health relatives to patients with depressive disorders.

    From the enrollment of all cases till three months later

  • Detect abnormalities in kynurenine pathway in patients with depressive disorders

    Blood samples will be collected from patients and healthy control cases in microbiology laboratory in Sohag university hospital; by using biokits for kynurenine to measure kynurenine level in nanomolar to low micromolar in liter, Add a tryptophan measure outcome to measure tryptophan level in micromol per liter Add a quinolinic acid measure outcome to measure quinolinic acid level in microgram per milliliter by ELISA

    From the time of enrollment till 3 months later

Eligibility Criteria

Age18 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with age group between 18: 60 years old and all cases are drug free of at least 4 months

You may qualify if:

  • age group 18: 60 years old
  • cases are drug free of at least 4 months

You may not qualify if:

  • patients with comorbid other psychiatric disorders( SUD,anxiety)
  • patients with IQ below 90
  • patients with psychotic features
  • patients with postpartum depression
  • patients with chronic medical illness that might affect immune function
  • patients under treatment with immune modulating therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depressive Disorder, MajorDepressive DisorderBipolar Disorder

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersBipolar and Related Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer at Sohag university hospital

Study Record Dates

First Submitted

August 3, 2026

First Posted

August 18, 2026

Study Start (Estimated)

March 14, 2027

Primary Completion (Estimated)

August 20, 2028

Study Completion (Estimated)

May 20, 2029

Last Updated

August 20, 2026

Record last verified: 2026-08