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Active, Not Recruiting

NCT Number: NCT05306184

Prospective Assessment of Cost-effectiveness and Side-effects of Depressive Patients Treated With ECT or TCA

Prospective observational cohort study to determine cost-effectiveness of ECT compared to medication in the treatment of major depressive disorder (MDD) in the Netherlands.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Depressive Disorder, Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GGz inGeest, Amsterdam, Netherlands

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About this study

Rationale:

Currently, detailed information on the cost-effectiveness of ECT based on real-world data is lacking, as well as the comparative cost-effectiveness with respect to medication. Reliable information on outcomes of ECT in comparison with antidepressant treatment and its cognitive side-effects is needed for patients and clinicians to make a balanced and shared decision regarding choosing or refraining from ECT.

Objective:

Primary Objective: determine (cost)-effectiveness of ECT compared to medication by determining the impact of treatment for MDD with ECT or TCA on remission rates using a one-year time horizon (trial-based economic evaluation)

Secondary Objective: determine side-effects of ECT compared to medication by determining the impact of treatment with ECT or medication on side-effects and quality of life during a one-year follow-up

Study design: Observational, parallel inception cohort study of patients who will undergo standard clinical care according to current guidelines.

Study population: 110 patients (>18 yrs.) with a depressive episode (unipolar MDD) who will start ECT (ECT group) and 110 patients (>18 yrs.) with a depressive episode (unipolar MDD) who will undergo treatment with antidepressants will be recruited from specialized clinics (academic hospital, general hospital and GGz-institute) and followed-up for one year to gather reliable data on efficacy including relapse rates, cost-effectiveness, quality of life and cognitive functioning.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients (>18 years) with a major depressive disorder who will either start with ECT or medication
  • failed response to at least 1 adequate dose-duration trial with antidepressants
  • moderate or severe depression (HDRS-17 >16)

Exclusion criteria

  • lifetime diagnosis schizophrenia or schizoaffective disorder, current substance abuse disorder, organic brain syndrome
  • the presence of a concurrent significant medical condition impeding the ability to participate

Treatment and study plan

Electroconvulsive therapy (ECT)

Procedure

ECT

Primary outcomes

  1. Effectiveness of treatment as measured by reduction on HDRS-17

    Time frame: change from baseline at 3 months, 6 months and 12 months

    Depression severity measured by The Hamilton Depression Rating Scale 17 item version (HDRS-17)

Secondary outcomes

  1. Cost-effectiveness as measured with The Trimbos Institute and iMTA Cost questionnaire for Psychiatry (TiC-P)

    Time frame: change from baseline at 3 months, 6 months and 12 months

    Cost-effectiveness as measured with The Trimbos Institute and iMTA Cost questionnaire for Psychiatry (TiC-P)

  2. Quality of life as measured with the EuroQol-5D (EQ-5D-5L)

    Time frame: change from baseline at 3 months, 6 months and 12 months

    Quality of life as measured with the EuroQol-5D (EQ-5D-5L)

  3. Cognitive functioning as measured by Montreal Cognitive Assesment (MoCA)

    Time frame: change from baseline at 3 months, 6 months and 12 months

    Cognitive functioning as measured by Montreal Cognitive Assesment (MoCA)

  4. COLUMBIA UNIVERSITY - AUTOBIOGRAPHICAL MEMORY INTERVIEW SHORT FORM (CU-AMI-SF)

    Time frame: change from baseline at 3 months, 6 months and 12 months

  5. Subjective Assessment of Memory Impairment (SAMI)

    Time frame: change from baseline at 3 months, 6 months and 12 months

    Subjective Assessment of Memory Impairment (SAMI)

  6. 15 words test (15WT)

    Time frame: change from baseline at 3 months, 6 months and 12 months

    (15WT; Saan & Deelman, 1986)

  7. Verbal fluency test (e.g., Lezak et al., 2012).

    Time frame: change from baseline at 3 months, 6 months and 12 months

    It typically consists of two tasks: category fluency (sometimes called semantic fluency; Benton, 1968) and letter fluency (sometimes called phonemic fluency; Newcombe, 1969). participants are given 1 min to produce as many unique words as possible within a semantic category (category fluency) or starting with a given letter (letter fluency).

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Canisius-Wilhelmina Hospital
  • Elisabeth-TweeSteden Ziekenhuis
  • GGZ inGeest
  • Parnassia
  • St. Antonius Hospital
  • UMC Utrecht

Registry information

Acronym: PROSPECT

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Apr 1, 2022
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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