CClinicalTrials.gg
Not yet recruitingNCT07853365Updated Oct 1, 2026

Predictors of Treatment Outcome in Major Depressive Disorder

An observational study in Major Depressive Disorder, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Assiut University · Observational

Updated Oct 1, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 60 Years
Sex
All
01

Study summary

Major depressive disorder (MDD) is a common and disabling mental health condition characterized by persistent low mood, loss of interest, and disruptions in sleep, appetite, and daily functioning. Response to treatment varies widely among individuals: while some respond to standard single-drug antidepressant therapy, others require medication combinations or electroconvulsive therapy (ECT). Currently, reliable clinical tools to predict which patients will respond best to specific treatment modalities remain limited.

The purpose of this prospective observational study is to identify sociodemographic and clinical factors that predict treatment response and remission at one month in patients diagnosed with MDD. The study specifically investigates whether baseline characteristics, such as age, sex, symptom profiles (including sleep disturbances, appetite changes, and functional impairment), and the presence of psychotic features, are associated with clinical improvement across different treatment approaches.

Adult participants aged 18 to 60 receiving psychiatric care at Assiut University Hospital are evaluated upon treatment initiation and followed for one month. Because this is an observational study, all treatment choices, including single antidepressants, combination pharmacotherapy, ECT, or combined regimens, are determined entirely by the treating medical team according to standard clinical practice. Depressive symptom severity and therapeutic response are measured at baseline and after one month using standardized clinical assessments, including the Hamilton Depression Rating Scale (HDRS).

02

Conditions studied

  • Major Depressive Disorder

Keywords

  • Major Depressive Disorder
  • Treatment Outcome
  • Clinical Predictors
  • Antidepressants
  • Electroconvulsive Therapy
  • Psychotic Depression
  • Hamilton Depression Rating Scale
03

In context

Depressive Disorder, Major

2,741 studies on the registry are indexed under Depressive Disorder, Major; 559 are open to participants now.

This study's planned enrollment of 100 is below the median of 140 across 357 observational studies indexed under Depressive Disorder, Major.

Browse Depressive Disorder, Major studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients aged 18 to 60 years admitted to inpatient wards or attending outpatient clinics at the Department of Neurology and Psychiatry, Assiut University Hospital, Assiut, Egypt, presenting with Major Depressive Disorder (MDD) diagnosed according to DSM-5-TR criteria and initiating active standard clinical treatment (pharmacological monotherapy, combination pharmacotherapy, electroconvulsive therapy [ECT], or combined regimens).

Inclusion criteria

  • Diagnosis of Major Depressive Disorder (MDD) according to DSM-5-TR criteria.
  • Age between 18 and 60 years, male or female.
  • Initiating active standard clinical treatment (pharmacological monotherapy, combination pharmacotherapy, electroconvulsive therapy [ECT], or combined regimens).
  • Willing and able to provide written informed consent (personally or through a legal guardian) and commit to the one-month follow-up assessment.

Exclusion criteria

Exclusion Criteria:

  • Comorbid major psychiatric disorders (e.g., schizophrenia, bipolar disorder).
  • Comorbid organic brain disease or unstable major medical illness that could confound clinical assessment.
  • Pregnancy or lactation.
  • Unwillingness or inability to complete the one-month follow-up period.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Major Depressive Disorder Cohort

    Patients aged 18-60 years diagnosed with Major Depressive Disorder according to DSM-5-TR criteria who are initiating active standard clinical treatment (pharmacological monotherapy, combination pharmacotherapy, electroconvulsive therapy \[ECT\], or combined regimens) at Assiut University Hospital.

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Treatment Response

    Treatment response is defined as achieving a 50% or greater reduction in the Hamilton Depression Rating Scale (HDRS-17) score from baseline. Total scores range from 0 to 52, with higher scores reflecting greater symptom severity.

    Time frame: 1 month

07

Study locations

No study locations are listed for this record.

08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07853365
Lead sponsor
Assiut University
Responsible party
Abdelrahim Mostafa Hassan Gomaa (Resident, Assiut University) — Principal investigator
First posted
Oct 1, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Oct 1, 2026
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion