Topic: Mental Health Research Network, Primary Care Research Network for England
Conditions
Interventions
Sertraline vs Placebo: The sertraline will be encapsulated and matching placebo capsules produced in order to maintain the blind during the study. Trial treatment will be for 12 weeks with assessments
Sponsors
University College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants presenting in primary care aged 18-74 with depressive symptoms and both the GP and patient are unsure whether there will be significant clinical benefit from taking SSRI antidepressants and not currently on antidepressants (or in previous 8 weeks). The trialists want to keep the inclusion criteria pragmatic and broad to reflect the current dilemma in clinical practice. They therefore think that the uncertainty of GP and patient about the possible benefits of antidepressants is the key entry criterion for the trial. They have included participants up to 74 years as additional clinical issues concerned with cognitive decline and social care become more common after that age. There may be situations where people with severe depressions would be included in the study and might receive placebo. The patient will always be free to consult their general practitioner during the study about any of their health concerns. The patient and GP can contact the PI at any time and seek advice about continuing with the study medication to stop the randomised treatment if there was deterioration or any other clinical need to start antidepressants. The trialists would allow hypnotic medication and other non-pharmacological treatment options including low intensity psychosocial treatments as provided by IAPT or counselling. The trialists will record this information and can investigate any impact on the findings in secondary analyses (and also use for the economic analysis). There is marked comorbidity between depression and anxiety disorders. The trialists are relying upon the GP referring subjects into the study to exclude all anxiety disorders that they have identified and wish to treat with SSRIs. The trialists will assess anxiety disorders at baseline and any influence of comorbid anxiety (that they expect will be quite common) on outcome can be examined in exploratory analyses. Target Gender: Male & Female; Upper Age Limit 74 years ; Lower Age Limit 18 years
Exclusion criteria
Exclusion criteria: 1. Anyone who is incapable of completing the questionnaires or who has other psychiatric disorders including psychosis, bipolar disorder, dementia, eating disorder, substance dependence, schizophrenia, mania, hypomania 2. Known allergies to the IMP, placebo or excipients 3. Poorly controlled epilepsy 4. Hepatic impairment 5. Currently on contraindicated medication: monoamine oxidase Inhibitors within 14 days or pimozide 6. Pregnant women Added 07/07/2017: 7. People with bleeding disorders such as haemophilia, Christmas disease and von Willebrands disease, as well as those with past medical history of bleeding gastric or duodenal ulcers or other significant bleeding disorders 8. An episode of Torsade’s de Pointes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depressive symptoms, measured with the PHQ9 questionnaire; Timepoint(s): 6 weeks follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| Added 11/07/2017: 1. Depressive symptoms, measured with the PHQ-9 at 2 and 12 weeks as a continuous outcome and at 2, 6 and 12 weeks as a binary outcome 2. Depressive symptoms, measured with the BDI-II at 2, 6 and 12 weeks 3. Anxiety symptoms, measured by the GAD-7 at 2, 6 and 12 weeks 4. Quality of life, measured with the EQ-5D-5L and SF-12 at 2, 6 and 12 weeks 5. Emotional processing task scores, measured at baseline, 2 and 6 weeks 6. Costs associated with health care use, time off work and personal costs over the 6 months period and measured at 12 weeks | — |
Countries
United Kingdom
Outcome results
None listed