Clinical trial • Psychiatry
Paroxetine hydrochloride for Major Depressive Disorder
Clinical trial of Paroxetine hydrochloride for Major Depressive Disorder.
Overview
- Trial Therapeutic Area
- Psychiatry
- Trial Disease
- Major Depressive Disorder
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 11-10-2024
- First CTIS Authorization Date
- 22-11-2024
Trial design
Randomised, placebo (matching modified product) and comparison of two tapering strategies for patients using paroxetine or venlafaxine; participant current doses are specified in eligibility (paroxetine 20-50 mg; venlafaxine 75-375 mg). no detailed schedule for comparator dosing stated.-controlled trial across 2 sites in Netherlands.
- Randomised
- Yes
- Comparator
- Placebo (matching modified product) and comparison of two tapering strategies for patients using paroxetine or venlafaxine; participant current doses are specified in eligibility (paroxetine 20-50 mg; venlafaxine 75-375 mg). No detailed schedule for comparator dosing stated.
- Target Sample Size
- 200
Eligibility
Recruits 200 Participants are adults aged 18-75; no vulnerable population selected (isVulnerablePopulationSelected:false). Participants must be willing and able to provide informed consent themselves. No assent or legal guardian consent procedures are described..
- Vulnerable Population
- Participants are adults aged 18-75; no vulnerable population selected (isVulnerablePopulationSelected:false). Participants must be willing and able to provide informed consent themselves. No assent or legal guardian consent procedures are described.
Inclusion criteria
- {"criterion_text":"- Age 18-75 years\n- Stable ≥6-month (≥1 year in recurrent MDD) remission of MDD, confirmed with a score of 12 or lower on the Patient Health Questionnaire 9 (PHQ-9)\n- Use of paroxetine (20-50mg) or venlafaxine (75-375mg)\n- Previous MDD episode and current remission confirmed with semi-structured psychiatric interview (MINI).\n- Willing and able to provide informed consent and follow the procedures necessary to participate in the study."}
Exclusion criteria
- {"criterion_text":"- Psychotic or bipolar disorder\n- Severe drug/alcohol addiction that warrants clinical attention\n- Use of other antidepressants (starting at the minimally effective dose), augmentation treatment (e.g. aripiprazole, olanzapine, lithium) and/or chronic high doses of benzodiazepines (daily use of >10mg diazepam equivalent)\n- Insufficient mastery of Dutch language."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Rate of failure to successfully discontinue antidepressant: defined as significant deviation from discontinuation antidepressant protocol (e.g. switching to rescue medication (≥5 days in total), stopping with discontinuation medication) or significant withdrawal symptoms (increase in modified 15-item DESS from baseline ≥4 for ≥2 consecutive assessments) during Phase II.","definition_or_measurement_approach":"Defined as significant deviation from discontinuation protocol (e.g. switching to rescue medication ≥5 days total, stopping discontinuation medication) or significant withdrawal symptoms measured as an increase in the modified 15-item DESS from baseline ≥4 for ≥2 consecutive assessments during Phase II."}
Recruitment
- Planned Sample Size
- 200
- Recruitment Window Months
- 43
- Consent Approach
- Informed consent must be provided by participants themselves (inclusion requires participants 'Willing and able to provide informed consent'). Subject information and informed consent form documents exist for adults (documents: 'L1_SIS and ICF adults' and 'Subject information and informed consent form (for publication)'). A Dutch translation of the trial title and materials is available; insufficient mastery of Dutch is listed as an exclusion criterion, indicating materials are provided in Dutch.
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 200
Netherlands
- Earliest CTIS Part Ii Submission Date
- 11-03-2024
- Latest Decision Or Authorization Date
- 22-11-2024
- Processing Time Days
- 256
- Number Of Sites
- 2
- Number Of Participants
- 200
Sites
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Psychiatry
- Principal Investigator Name
- Christiaan Vinkers
- Principal Investigator Email
- tempo@amsterdamumc.nl
- Contact Person Name
- Christiaan Vinkers
- Contact Person Email
- tempo@amsterdamumc.nl
- Site Name
- Radboud universitair medisch centrum / RADBOUDUMC
- Department Name
- Psychiatry
- Principal Investigator Name
- Eric Ruhé
- Principal Investigator Email
- tempo.psy@radboudumc.nl
- Contact Person Name
- Eric Ruhé
- Contact Person Email
- tempo.psy@radboudumc.nl
Sponsor
Primary sponsor
- Full Name
- Amsterdam UMC Stichting
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- PAROXETINE
- Active Substance
- Paroxetine hydrochloride
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Market authorised (registered and on the market)
- Starting Dose
- 20 mg
- Dose Levels
- 20-50 mg
- Maximum Dose
- 50 mg
- Investigational Product Name
- VENLAFAXINE
- Active Substance
- Venlafaxine
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Market authorised (registered and on the market)
- Starting Dose
- 75 mg
- Dose Levels
- 75-375 mg
- Maximum Dose
- 375 mg
Related trials
Other published trials that may interest you.