Depression Mental and Behavioural Disorders Depression
Conditions
Interventions
Current intervention as of 27/09/2018:
At baseline participants will be taking either citalopram (20 mg), sertraline (100 mg), fluoxetine (20 mg) or mirtazapine (30 mg). They will be r
Sponsors
PRIMENT CTU, University College London
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 27/09/2018: 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. Previous primary outcome measure: 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 01/10/2018: 1. Depressive symptoms will be measured using the PHQ9 at baseline, 6 weeks, 12 weeks, 26 weeks, 39 weeks, 52 weeks 2. Anxiety symptoms will be measured using the GAD7 questionnaire at baseline, 6 weeks, 12 weeks, 26 weeks, 39 weeks, 52 weeks 3. Quality of life will be measured using the EQ5D-5L questionnaire for quality adjusted life years (QALYs) at baseline, 12 weeks, 26 weeks, 39 weeks, 52 weeks 4. Adverse effects of antidepressants will be measured using a modified Toronto Side Effects scale at baseline, 6 weeks, 12 weeks, 26 weeks, 39 weeks, 52 weeks 5. Adherence to study medication will be measured using the same criteria as used in the COBALT trial to define adherence using a 5-item self-report measure of compliance at baseline, 6 weeks, 12 weeks, 26 weeks, 39 weeks, 52 weeks 6. Quality of life will be measured using the Health related quality of life questionnaire (SF12) at baseline, 12 weeks, 26 weeks, 39 weeks and 52 weeks 7. Withdrawal symptoms based on DESS will be measures at baseline, 6 weeks, 12 weeks, 26 weeks, 39 weeks and 52 weeks 8. Healthcare resource use collected from GP electronic records 9. Patient’s overall impression of their wellbeing assessed using a global rating question with 5 points ranging from ‘I feel a lot better’ to ‘I feel a lot worse’ asked at baseline, 6 weeks, 12 weeks, 26 weeks, 39 weeks and 52 weeks follow-up Previous secondary outcome measures as of 27/09/2018: 1. Depressive symptoms will be measured using the PHQ9 at baseline, 6 weeks, 12 weeks, 26 weeks, 39 weeks, 52 weeks 2. Anxiety symptoms will be measured using the GAD7 questionnaire at baseline, 6 weeks, 12 weeks, 26 weeks, 39 weeks, 52 weeks 3. Quality of life will be measured using the EQ5D-5L questionnair | — |
Countries
England, United Kingdom
Contacts
Public ContactLarisa Duffy
Outcome results
None listed