Predictors of Treatment Outcome in Major Depressive Disorder

NCT07853365 | Not Yet Recruiting

• 1 other identifier: Treatment Predictors in MDD
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Major Depressive Disorder

Keywords

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

Outcome Measures

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.

  1 month

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: September 26, 2026
• First Posted: October 1, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09