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Trial record 92 of 125 for:    "Depressive Disorder" [DISEASE] AND Behavioral | ( Map: Spain )

Predicting Response to Depression Treatment (PReDicT)

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ClinicalTrials.gov Identifier: NCT02790970
Recruitment Status : Active, not recruiting
First Posted : June 6, 2016
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
P1vital Products Limited

Brief Summary:

Depression is a very common, serious and in some cases life‐threatening condition, affecting around 350 million people globally. Approximately 11% of citizens in the European Union suffer from depression at some point in their lives. Depression is associated with significant socio-economic costs and has been predicted to become the greatest cause of disability worldwide by 2030 . In 2010 it was estimated that there were approximately 30 million patients with depression in Europe, with aggregated economic costs of approximately €92 billion . Improvements in managing the treatment of depression are urgently needed to improve patient outcomes, contain rising healthcare costs, improve workplace productivity and help to address global economic and societal challenges.

While a range of effective antidepressant medications are available to treat depression, it takes 4-6 weeks after starting antidepressant treatment before a physician can detect whether the treatment is working. However, surprisingly, more than 50% of patients fail to respond to the first antidepressant treatment they are prescribed. Therefore, it often takes several months to identify an effective antidepressant treatment for the majority of patients with depression. During this time a patient's ability to work and function socially is severely impaired. Individuals may be absent from work for many weeks or months and this places a substantial burden on the economy and on healthcare resources.


Condition or disease Intervention/treatment Phase
Depression Device: PReDicT Test Other: Treatment as Usual Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 913 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interventional, Randomised, Open Label, Multi-centre, Parallel-group, Controlled Study Investigating the Effects of Using the PReDicT Test to Guide the Antidepressant Treatment of Depressed Patients
Study Start Date : May 2016
Actual Primary Completion Date : November 30, 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
Experimental: PReDicT Test
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
Device: PReDicT Test
PReDicT Test, when completed 7-9 days after starting antidepressant treatment, is able to predict a patient's subsequent response to that antidepressant treatment 4-6 weeks later

Placebo Comparator: Treatment as usual
Treat patients as usual without using the predict test to determine treatment.
Other: Treatment as Usual
Patients treated by the clinician conventionally using signs and symptoms to determine treatment changes or medication changes.




Primary Outcome Measures :
  1. Increase in proportion of depressed patients showing a response to treatment at week 8 when using the PReDicT Test to direct antidepressant treatment compared to treatment as usual as measured by the QIDS-SR-16 [ Time Frame: 8 weeks ]
    QIDS-SR-16 is a standard questionnaire "The Quick Inventory of Depressive Symptomatology" (16-Item) (Self-Report). This covers questions on falling asleep, sleep during the night, waking up , sleeping too much, feeling sad ,appetite, weight, concentration , how they view themselves, thoughts of death and suicide, general interests, energy levels, feeling slowed down , feeling restless. These will be compared at baseline and after 8 weeks of treatment.


Secondary Outcome Measures :
  1. Compare the change from baseline in QIDS-SR-16 scores [ Time Frame: 8 weeks ]
    To compare the change from baseline in QIDS-SR-16 scores (i.e. treated as a continuous variable) at week 8 between depressed patients receiving treatment directed by the PReDicT Test and those receiving TaU.

  2. Increase in proportion of depressed patients showing a response to treatment at week 8 when using the PReDicT Test to direct antidepressant treatment compared to treatment as usual as measured by a reduction of >50% in the MADRS score [ Time Frame: 8 weeks ]
    • 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 scores.(Montgomery-Åsberg Depression Rating Scale)

  3. Increase in proportion of depressed patients showing remission from depression at week 8 when using the PReDicT Test to direct antidepressant treatment compared to treatment as usual as measured by a QIDS-SR-16 score <=5 [ Time Frame: 8 Weeks ]
    • 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 a QIDS-SR-16 score of 5 or less.

  4. Compare changes in baseline of the QIDS-SR-16 score [ Time Frame: 12 weeks ]
    • To compare the change from baseline in 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.

  5. Compare changes in baseline of the QIDS-SR-16 score [ Time Frame: 24 weeks and 48 weeks ]
    • To compare the change from baseline in 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.

  6. Health economic analysis on societal costs and cost-effectiveness/cost-utility of the PReDicT Test compared with Treatment as Usual as measured by the EQ-5D-5L [ Time Frame: 24 weeks and 48 weeks (optional) ]
    Health economic analysis will include: (i) a detailed patient-level cost analysis of health, social care and other broader societal costs for both the PReDicT and the TaU arms of the study and (ii) an incremental within-trial economic evaluation comparing the PReDicT arm and the TaU arm of the study in terms of their costs and outcomes over the 6 months main trial follow-up period (week 0 to week 24). An optional analysis of the data after 12 months (week 0 to week 48) may also be performed.

  7. Health economic analysis on societal costs and cost-effectiveness/cost-utility of the PReDicT Test compared with Treatment as Usual as measured by the QIDS-SR-16 [ Time Frame: 24 weeks and 48 weeks (optional) ]
    Health economic analysis will include: (i) a detailed patient-level cost analysis of health, social care and other broader societal costs for both the PReDicT and the TaU arms of the study and (ii) an incremental within-trial economic evaluation comparing the PReDicT arm and the TaU arm of the study in terms of their costs and outcomes over the 6 months main trial follow-up period (week 0 to week 24). An optional analysis of the data after 12 months (week 0 to week 48) may also be performed.

  8. Health economic analysis on societal costs and cost-effectiveness/cost-utility of the PReDicT Test compared with Treatment as Usual as measured by the OxCAP-MH [ Time Frame: 24 weeks and 48 weeks (optional) ]
    Health economic analysis will include: (i) a detailed patient-level cost analysis of health, social care and other broader societal costs for both the PReDicT and the TaU arms of the study and (ii) an incremental within-trial economic evaluation comparing the PReDicT arm and the TaU arm of the study in terms of their costs and outcomes over the 6 months main trial follow-up period (week 0 to week 24). An optional analysis of the data after 12 months (week 0 to week 48) may also be performed.

  9. Health economic analysis on societal costs and cost-effectiveness/cost-utility of the PReDicT Test compared with Treatment as Usual as measured by the HEQ [ Time Frame: 24 weeks and 48 weeks (optional) ]
    Health economic analysis will include: (i) a detailed patient-level cost analysis of health, social care and other broader societal costs for both the PReDicT and the TaU arms of the study and (ii) an incremental within-trial economic evaluation comparing the PReDicT arm and the TaU arm of the study in terms of their costs and outcomes over the 6 months main trial follow-up period (week 0 to week 24). An optional analysis of the data after 12 months (week 0 to week 48) may also be performed.

  10. Obtain further feasibility data [ Time Frame: 48 weeks ]
    Acceptability questionnaires will be reported using descriptive statistics. Free text comments will be analysed thematically. Questionnaire and demographic data will be used to guide sampling for the semi-structured interviews.

  11. Assess the acceptability and perceived value of the PReDicT Test [ Time Frame: 48 weeks ]
    Acceptability questionnaires will be reported using descriptive statistics. Free text comments will be analysed thematically. Questionnaire and demographic data will be used to guide sampling for the semi-structured interviews.

  12. Compare the change from baseline in GAD-7 score [ Time Frame: 8 Weeks ]
    To compare the change from baseline in GAD-7 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. (GAD-7: Generalised Anxiety Disorder Questionnaire, 7 item version

  13. Compare the change from baseline on the depression and anxiety items [ Time Frame: 8 weeks ]
    To compare the change from baseline on the depression and anxiety items (analysed separately) of the QIDS-SR-16 at week 8 between depressed patients receiving treatment directed by the PReDicT Test and those receiving TaU by analysis of the QIDS-SR-16 using linear regression to quantify treatment effects with a baseline measure included as a covariate

  14. Determine the change of cognitive function [ Time Frame: 8 weeks ]

    To determine the change of cognitive function (assessed using the DSST) from baseline to week 8 between depressed patients receiving treatment directed by the PReDicT Test and those receiving TaU.

    o DSST: Digit Symbol Substitution Test.


  15. Compare the change from baseline in self-reported social and occupational functioning [ Time Frame: weeks 8, 24 and 48 ]

    To compare the change from baseline in self-reported social and occupational functioning at weeks 8, 24 and 48 between depressed patients receiving treatment directed by the PReDicT Test and those receiving TaU.

    • Social and occupational functioning will be assessed by SAS-SR (screener version).
    • SAS-SR: Social Adjustment Scale - Self-Report (screener version). by which will be followed up monthly over the period of one year, multilevel modelling will be conducted to quantify treatment effects with 'participant' as a level two unit, treatment status and treatment x time interactions. Baseline measurement will be included in multilevel model as a covariate

  16. Device safety as required by medical devices legislation [ Time Frame: 48 weeks ]
    Analysis of Safety will be reviewed and reported using descriptive statistics



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female aged between 18 and 70 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 7 days prior to Visit 1, but has not yet started taking medication.
  • Is intending to start SSRI treatment within 7 days of Visit 1.

Exclusion Criteria:

  • Previous history of mania.
  • Is currently taking an antidepressant medication or has stopped antidepressant treatment within 2 weeks prior to Visit 1.
  • Requires immediate referral to alternative mental health services (e.g. where a patient seen in primary care is referred to secondary care services).
  • Presents to a physician with significant current suicidal intent requiring enhanced care.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02790970


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Sponsors and Collaborators
P1vital Products Limited
Investigators
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Principal Investigator: Mike Browning P1vital Limited

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: P1vital Products Limited
ClinicalTrials.gov Identifier: NCT02790970     History of Changes
Other Study ID Numbers: P1V-DEP-MD03
First Posted: June 6, 2016    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs