What are the indications for Prescribing ANtiDepressAnts that lead to a clinical benefit? PANDA
- Conditions
- depressionMedDRA version: 18.0Level: LLTClassification code 10027942Term: Mood depressionSystem Organ Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2013-003440-22-GB
- Lead Sponsor
- niversity College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 547
1.Age: 18-74 (inclusive)
2.Gender: both female and male
3.Depression presenting in primary care
4.Clinical equipoise about the benefits of SSRI medication
5. People who are having other interventions such as low intensity IAPT can also take part
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 47
1.Antidepressant medication in the preceding 8 weeks.
2.Unable to read, understand and/or complete questionnaires
3.Other psychiatric disorders: psychosis, schizophrenia, bipolar disorder, mania, hypomania, dementia, eating disorder.
4.Major alcohol or substance misuse problems
5.Currently on contraindicated medication: monoamine oxidase Inhibitors within the past 14 days or pimozide.
6.Patients with poorly controlled epilepsy
7.Known allergies to the IMP, placebo or excipients
8.Concurrent enrolment in another IMP trial
9.Women who are currently pregnant or planning pregnancy or lactating
10.Severe hepatic impairment
11Bleeding disorders such as 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the severity and duration of the depressive symptoms that are associated with a clinically important response (compared to placebo) to sertraline in people with depression;Secondary Objective: We will also investigate quality of life, the economic costs and whether emotional processing tasks are associated with response to treatment with sertraline. ;Primary end point(s): PHQ 9 questionnaire as a continuous score ;Timepoint(s) of evaluation of this end point: at 6 weeks follow-up.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Depressive symptoms with the PHQ9 at 2 & 12 weeks as a continuous outcome and 2, 6 & 12 weeks as a binary outcome. BDI-II as an alternative measure of depressive symptoms as continuous and binary at all follow up points. Anxiety symptoms measured using the GAD7 as a continuous and binary measure at all follow-up points. Quality of life assessed using the EQ5D and SF12. Economic costs associated with the treatment. Emotional processing tasks at 2 and 6 weeks.<br><br><br>;Timepoint(s) of evaluation of this end point: PHQ9, BDI-II and GAD7, EQ5D and SF12 at 2, 6 and 12 weeks. Emotional processing tasks at 2 and 6 weeks