Predictors of Treatment Outcome in Major Depressive Disorder
ConditionMajor Depressive Disorder
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorAssiut University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Major Depressive Disorder Cohort
Trial outcomes
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 monthLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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