Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-resistant Depression

Официальное название

Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-Resistant Depression: a Randomised, Rater-blinded Trial

Обзор

The goal of this study is to compare the effectiveness of two formulations of ketamine - Spravato® and racemic ketamine - in people with treatment-resistant depression (TRD). The main questions it aims to answer are: * How the two formulations compare in terms of their effectiveness in treating TRD. * How the two formulations compare in their acceptability to patients, safety, effects on patient quality of life and function, and cost effectiveness. Participants will be randomised to receive either Spravato® or racemic ketamine treatment and asked to complete some questionnaires to assess the effects on mood, treatment acceptability, side effects, quality of life and function, and health economic outcomes.

Подробное описание

The TREK study is a randomized, prospective, rater blinded (primary outcome raters), parallel group, comparative effectiveness trial of racemic ketamine and Spravato®, comparing their effectiveness, acceptability, safety, effects on quality of life (QOL), function and cost effectiveness after 4 weeks - 6 months of treatment in people with TRD.

Participants will be recruited from clinics/hospitals that are providing racemic ketamine and Spravato® treatment services for TRD. Participants will be referred, treated and followed up as per the clinic's normal clinical practice. Participants who consent to participate in this research study will undergo other processes in addition to the standard treatment procedures provided by their clinic:

* Randomisation to receive racemic ketamine or Spravato®. * Completion of questionnaires to measure treatment effects on mood, acceptability, safety, quality of life and function and cost effectiveness.

Вмешательства

• Препарат Esketamine group
  The recommended dosing for Spravato is: Weeks 1-4: Starting Day 1 dose: \< 65 years: 56 mg ≥ 65 years: 28 mg Subsequent doses: 28 mg (≥ 65 years), 56 mg or 84 mg twice weekly Weeks 5-8: 28 mg (≥ 65 years), 56 mg or 84 mg once weekly From Week 9: 28 mg (≥ 65 years), 56 mg or 84 mg every 2 weeks or once weekly
• Препарат Racemic ketamine
  Typically, dosing will begin at the standard dose of 0.5 mg/kg and adjusted as needed using an ascending dose titration schedule: 1. 0.5 mg/kg 2. 0.6 mg/kg 3. 0.75 mg/kg 4. 0.9 mg/kg 5. Further increments by 0.1-0.2 mg/kg, up to max 1.5 mg/kg

Первичные конечные точки

• Montgomery-Asberg Depression Rating Scale (MADRS) [Срок оценки: From week 0 to week 4.]

Вторичные конечные точки (12)

• Montgomery-Asberg Depression Rating Scale (MADRS) score [Срок оценки: At week 8, month 4 and month 6]
• Response - Montgomery-Asberg Depression Rating Scale (MADRS) [Срок оценки: Weeks 4, 8 and months 4 and 6]
• Remission - Montgomery-Asberg Depression Rating Scale (MADRS) [Срок оценки: Weeks 4, 8 and months 4 and 6]
• DASS-21 [Срок оценки: Performed weekly from baseline to week 8 inclusive and at 6 month visit.]
• Clinical Global Impression-Improvement (CGI-I) [Срок оценки: Performed weekly from week 1 to week 4 inclusive, then at week 8 and at 3, 4, 5 & 6 month visits.]
• Clinical Global Impression-Severity (CGI-S) [Срок оценки: Performed weekly from baseline to week 4 inclusive, then at week 8 and at 3, 4, 5 & 6 month visits.]
• Columbia Suicide Severity Rating Scale (C-SSRS) [Срок оценки: Performed weekly from baseline to week 4 inclusive, then at week 8 and at 3, 4, 5 & 6 month visits.]
• Speed of response - Clinical Global Impression-Improvement (CGI-I) [Срок оценки: Performed weekly from week 1 to week 4 inclusive, then at week 8 and at 6 month visits.]
• Psychotomimetic symptoms [Срок оценки: Through study completion at each treatment visit, up to 6 months]
• Suicide attempts or gestures [Срок оценки: During 6-month study period]
• Number of Participants with urinary symptoms, as assessed using the Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS) [Срок оценки: Performed at baseline, week 4, week 8 and at 6 month visit.]
• Cognitive Failure Questionnaire scores (CFQ) [Срок оценки: Performed at baseline, week 4, week 8 and at 6 month visit.]

Критерии участия

Критерии включения

• Adult with treatment-resistant depression (TRD: not responded adequately to at least two different antidepressants of adequate dose and duration) who has a current depressive episode (DSM 5)
• Assessed and attested by clinic psychiatrist as appropriate to receive either racemic ketamine or Spravato® ketamine treatment for TRD
• MADRS score of ≥20 at study baseline, assessed by certified study rater
• Aged ≥18 years
• Written informed consent for research study obtained

Критерии исключения

• Not able to give informed consent
• Any physical or mental condition which, in the opinion of the investigator, could interfere with study participation including outcome assessments
• Any treatment with ketamine or Spravato® within 4 weeks prior to written informed consent for the research study
• Patients who require an interpreter/translator for the clinic consent process, due to the infeasibility of obtaining an interpreter for research assessments, including self-rated scales

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Австралия · 7 центров

• Royal Prince Alfred Hospital — Camperdown
• Black Dog Institute — Randwick
• Ramsay Clinic Northside — St Leonards
• Ramsay Clinic Lakeside — Warners Bay
• Gold Coast University Hospital — Southport
• Ramsay Clinic Albert Road — Melbourne
• Royal Melbourne Hospital — Parkville

Идентификаторы

NCT: NCT06278779 · X23-0311

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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