Clinical Predictors of Treatment Outcome in Major Depressive Disorder
| Registry | NCT07853365 |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 100 (Estimated) |
| Sponsor | Assiut University (Other) |
| Conditions | Major Depressive Disorder |
| Dates | start 2026-10-01 (estimated), primary completion 2027-10-01 (estimated), completion 2027-11-01 (estimated), first posted 2026-10-01, last updated 2026-10-01 |
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All trials for Major Depressive Disorder
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 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. |
Sex: All, ages: 18 Years to 60 Years
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: * 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.