Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Predictors of Treatment Outcome in Major Depressive Disorder

26. september 2026 opdateret af: Abdelrahim Mostafa Hassan Gomaa, Assiut University

Clinical Predictors of Treatment Outcome in 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).

Studieoversigt

Status

Ikke rekrutterer endnu

Undersøgelsestype

Observationel

Tilmelding (Anslået)

100

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 60 år (Voksen)

Tager imod sunde frivillige

N/A

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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).

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Treatment Response
Tidsramme: 1 month

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. oktober 2027

Studieafslutning (Anslået)

1. november 2027

Datoer for studieregistrering

Først indsendt

26. september 2026

Først indsendt, der opfyldte QC-kriterier

26. september 2026

Først opslået (Faktiske)

1. oktober 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner