depression mood disorder
Conditions
Interventions
The intervention consists in using the PReDicT test to guide antidepressant
treatment.
depression
emotion recognition
intervention
Sponsors
P1vital Products Limited
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Male or female and aged between 18 and 65 inclusive. - Diagnosed with a depressive episode by a physician (either first episode or recurrent) and requiring treatment with a selective serotonin reuptake inhibitor (SSRI) medication (excluding fluoxetine). - Prescribed an SSRI by a physician for the treatment of depression within the 7 days prior to Visit 1, but has not yet started taking the medication. - Is intending to start SSRI treatment within 7 days of Visit 1.
Exclusion criteria
Exclusion criteria: - Previous history of mania. - Is currently taking an antidepressant medication or has stopped antidepressant treatment within 2 weeks prior to Visit 1. Participants who are taking or have taken antidepressant medication for treatment of a different condition at a dose which does not have an antidepressant effect are eligible for inclusion. - Requires immediate referral to alternative mental health services (e.g. where patient seen in primary care is referred to secondary care services). - Presents to a physician with significant current suicidal intent requiring enhanced care.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint * Change in QIDS-SR-16 score from week 0 (baseline) to week 8. [Quick Inventory of Depressive Symptomology - Self Report] | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives: * To compare the change from in QIDS-SR-16 score at baseline in to QIDS-SR-16 score QIDS-SR-16 score (i.e. treated as a continuous variable) at week 8 between depressed patients receiving treatment directed by the PReDicT Test and those receiving TaU. * To determine whether use of the PReDicT Test to direct antidepressant treatment results in an increased proportion of depressed patients showing a response to treatment at week 8 compared to TaU, where response is defined as a decrease of 50% or more from baseline MADRS score. o MADRS: Montgomery*Åsberg Depression Rating Scale. * To determine whether use of the PReDicT Test to direct antidepressant treatment results in an increased proportion of depressed patients achieving remission at week 8 compared to TaU where remission is defined as QIDS-SR-16 score of 5 or less. * To determine whether use of the PReDicT Test to direct antidepressant treatment results in an increased proportion of depressed patients achieving remission at week 8 compared to TaU where remission is defined as MADRS score of 7 or less. * To compare the change from the QIDS-SR-16 score at baseline to the QIDS-SR-16 scorein QIDS-SR-16 score (i.e. treated as a continuous variable) at week 12 between depressed patients receiving treatment directed by the PReDicT Test and those receiving TaU. * To compare the change from QIDS-SR-16 score at baselinebaseline in to QIDS-SR-16 score (i.e. treated as a continuous variable) at 24 and 48 weeks between depressed patients receiving treatment directed by the PReDicT Test and those receiving TaU. Health Economic Objectives * To determine the impact on societal costs and cost-effectiveness/cost-utility of the PReDicT Test intervention in comparison to TaU over 24 weeks. * To determine the impact on societal costs and cost-effectiveness/cost-utility of the PReDicT Test intervention in comparison to TaU over 48 weeks. Acceptability and Implementation Obje | — |
Countries
The Netherlands
Outcome results
None listed