ISRCTN15969819CompletedPhase 4
A Phase IV double blind multi-site, individually randomised parallel group controlled trial investigating the use of citalopram, sertraline, fluoxetine and mirtazapine in preventing relapse in patients in primary care who are taking long term maintenance antidepressants but now feel well enough to consider stopping medication
PRIMENT CTU, University College London0 sites478 target enrollmentStarted: September 21, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 478
Study Overview
Brief Summary
2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31159856 protocol (added 05/06/2019) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34587384/ results (added 30/09/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34748164/ Cost-Utility Analysis (added 10/11/2021) 2021 Funder report results in https://pubmed.ncbi.nlm.nih.gov/34842135/ (added 30/11/2021) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/36928675/ Substudy results (added 10/10/2023)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Aged between 18 and 74 years
- •2. Have experienced at least two episodes of depression
- •3. Have been taking antidepressants for at least 9 months (citalopram 20mg, sertraline 100mg, fluoxetine 20mg or mirtazapine 30mg)
- •4. Be well enough to consider stopping their antidepressant medication
Exclusion Criteria
- •Current exclusion criteria as of 27/09/2018:
- •1. Meet internationally agreed (ICD10) criteria for a depressive illness
- •2. Have bipolar disorder, psychotic illness, dementia or a terminal illness
- •3. Are not able to complete self-administered questionnaires in English
- •4. Have contraindications for any of the prescribed medication
- •5. Women who are currently pregnant or planning pregnancy or lactating
- •6. Concurrently enrolled in another investigational medicinal product (IMP) trial
- •Previous exclusion criteria:
- •1. Meet internationally agreed (ICD10) criteria for a depressive illness
- •2. Score above 10 on the depressive symptom questionnaire (PHQ9)
- •3. Have bipolar disorder, psychotic illness, dementia or a terminal illness
- •4. Are not able to complete self-administered questionnaires in English
- •5. Have contraindications for any of the prescribed medication
Investigators
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