MedPath

Antidepressants to prevent relapse in depressio

Phase 4
Completed
Conditions
Depression
Mental and Behavioural Disorders
Registration Number
ISRCTN15969819
Lead Sponsor
PRIMENT CTU, University College London
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)

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
478
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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<br> Current primary outcome measure as of 27/09/2018:<br> Time to depressive relapse measured using the modified shortened clinical interview schedule-revised (CIS-R) at baseline, 6 weeks, 12 weeks, 26 weeks, 39 weeks and 52 weeks.<br><br> Previous primary outcome measure:<br> Time to depressive relapse measured using the modified shortened clinical interview schedule-revised (CIS-R) at baseline, 12 weeks, 26 weeks, 39 weeks and 52 weeks.<br>
Secondary Outcome Measures
NameTimeMethod
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