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The Antidepressant Advisor Study (ADeSS)

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ClinicalTrials.gov Identifier: NCT03628027
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : March 7, 2019
Sponsor:
Collaborators:
NHS Lambeth Clinical Commissioning Group
EMIS PLC
D'Or Institute for Research and Education
Information provided by (Responsible Party):
Dr Roland Zahn, King's College London

Brief Summary:
The Antidepressant Advisor Study is a feasibility study to develop and probe the feasibility of a computerised decision support tool for GPs to prescribe antidepressant treatments. The study will use an algorithm to support GPs in their prescribing decisions for patients who have previously not responded to first-line antidepressants. Another group of GPs will prescribe as usual without the algorithm so that the effectiveness of the tool can be assessed, in terms of patient recovery. The aim of the study is to design a support tool which can aid GPs to prescribe the most effective treatment option for the patient so that they have increased likelihood of improvement in depression. A further aim of the study is to assess GP adherence and satisfaction with the tool so that modifications can be made that would improve the usability of the tool in future trials.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: Computerised decision support algorithm Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster-randomised controlled clinical trial. GPs are randomised in blocks of N = 2 to a treatment arm. All patients under the care of a GP receive the treatment to which the GP was randomised.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: GPs will need to be made aware of their treatment arm in order to implement the correct treatment. However, this should not be disclosed to patients, either by the GP or Trial Co-ordinator who will also be blinded.
Primary Purpose: Other
Official Title: The Antidepressant Advisor: A Decision Support System for UK Primary care-a Feasibility Study
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
Experimental: Treatment Algorithm
The treatment algorithm arm will be the experimental arm in which GPs use the computerised decision support tool to guide their prescribing of antidepressants.
Device: Computerised decision support algorithm
The algorithm is integrated into the EMIS computer system used by GPs. The algorithm advises on which antidepressants should be prescribed based on a patient's treatment history.

No Intervention: Treatment-as-usual
The treatment-as-usual arm will comprise GPs prescribing antidepressants and providing care as they typically would.



Primary Outcome Measures :
  1. Self-Rated Quick Inventory of Depressive Symptomatology (QIDS-SR16) [ Time Frame: 16 weeks ]
    Change from baseline depressive symptoms (not primary outcome for this feasibility study, only for full trial, primary feasibility outcomes are listed from 6 onwards). Total scale range: 0 - 48. Higher score indicates more change in depressive symptoms.


Secondary Outcome Measures :
  1. Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 16 weeks ]
    Change from baseline depressive symptoms. Total scale range: 0 - 60. Higher score indicates more change in depressive symptoms.

  2. Clinical Global Impression [ Time Frame: 16 weeks ]
    Change from baseline severity Total scale range: 1 - 7. Lower score indicates more improvement in symptoms.

  3. Generalised Anxiety Disorder (GAD-7) [ Time Frame: 16 weeks ]
    Change from baseline anxiety symptoms used in the NHS. Total scale range: 0 - 21. Higher score indicates more change in anxiety symptoms.

  4. Body Mass Index (BMI) [ Time Frame: 16 weeks ]
    Change from baseline healthy weight. Total range: 12 - 42. Higher score indicates more change in BMI.


Other Outcome Measures:
  1. Recruitment Rate [ Time Frame: Through study completion, an average of 16 months ]
    Rate at which patients are recruited to the study

  2. Lost to Follow-up Rate [ Time Frame: Through study completion, an average of 16 months ]
    Rate at which patients are lost to follow-up

  3. Adverse Event Rate [ Time Frame: Through study completion, an average of 16 months ]
    Grade and rate at which adverse events occur

  4. Helpfulness, ease of use and workload of intervention using King's GP Satisfaction Measure [ Time Frame: Through study completion, an average of 16 months ]
    Average GP satisfaction. Includes recommendation for future clinical use, and opinion on usefulness to patient care. Subscale ranges-Q1: 0 - 11, Q2: 0 - 6 (higher score indicates more improved care), Q3: 0 - 6 (higher score indicates higher workload), Q4: 0 - 6 (higher score indicates higher helpfulness), Q5: 0 - 6 (higher score indicates higher workload), Q6: 0 - 6 (higher score indicates easier to use), Q7: 0 - 6 (higher score indicates more improvement in care), Q8: 0 - 6 (higher score indicates better than other tools), Q9: 0 - 6 (higher score indicates less likelihood to ignore tool), Q10: 0 - 6 (higher score indicates more strongly recommend)

  5. GP Adherence to Algorithm [ Time Frame: Week 16 ]
    Assessed for each patient by trial clinician, from 0 (none of the recommended steps implemented) to 3 (fully implemented)

  6. Service Use (EMIS) [ Time Frame: Week 16 ]
    Information taken from EMIS, including psychiatric referrals, referrals to study psychiatrist, time to psychiatric referral

  7. Adult Service Use Schedule (AD-SUS) [ Time Frame: Week 16 ]
    Assessed on routine validated KCL questionnaire. Subscale ranges: Q1: 0 (no) 1 (yes), Q2: continuous number, Q3: 0 (no), 1 ( yes), Q4: continuous number, Q5: 0 (no), 1 (yes), Q6: text answer, Q7: continuous number

  8. Euroqol Quality of Life Measure (EQ-5D-3L) [ Time Frame: Week 16 ]
    Change from baseline quality of life. Assessment of cost-effectiveness of intervention. Visual analogue question range: 0 - 100. Higher score indicates better perceived health.

  9. Average % Patient Adherence (EMIS) [ Time Frame: Week 16 ]
    Information taking from EMIS including prescribing records

  10. Social and Occupational Functioning Assessment Scale (SOFAS; DSM-V) [ Time Frame: Week 16 ]
    Change from baseline psychological functioning

  11. Maudsley Visual Analogue Mood Scale [ Time Frame: Week 16 ]
    Change from baseline mood. Total scale range: 0 - 300. Higher scores indicate more improvement in mood.

  12. Patient Adherence [ Time Frame: Week 16 ]
    Information taken from EMIS including % of attended GP visits out of total scheduled number

  13. Frequency, Intensity and Burden of Side Effects Rating (FIBSER) [ Time Frame: Weekly for 16 weeks ]
    Average score for medication side effects. Each subscale range: 0 - 6. Higher scores indicate more burdensome side effects.

  14. Average % Patient Adherence (Mobile App) [ Time Frame: Weekly for 16 weeks ]
    Adherence to prescribed antidepressants

  15. Average Maudsley Modified Patient Health Questionnaire (PHQ-9) [ Time Frame: Weekly for 16 weeks ]
    Average depression score over last 2 weeks. Total scale range: 0 - 21. Higher scores indicate more depressive symptoms.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • age 18 years +
  • at least moderately severe major depressive syndrome on PHQ-9 (score 15 +)
  • no plans to change GP practice
  • able to complete self-report scales orally or in writing
  • no previous prescription of mirtazapine or vortioxetine
  • early treatment resistance as defined by 1) current or recent prescription (in the last 2 months) of any of the following antidepressants: citalopram, fluoxetine, sertraline, escitalopram, paroxetine, venlafaxine, or duloxetine AND 2) previous prescription of at least one other antidepressant out of the same list.

Exclusion Criteria:

  • inability to consent to study
  • unstable medical condition
  • currently receiving specialist psychiatric treatment
  • high suicide risk (MINI suicidality screen)
  • past diagnosis of schizophrenia or schizo-affective disorder
  • current psychotic symptoms (3 clinical screening questions)
  • bipolar disorder
  • currently at risk of being violent
  • drug (modified PHQ) or alcohol abuse (PHQ) over last 6 months
  • suspected central neurological condition
  • pregnancy or insufficient contraception in women of childbearing age
  • breastfeeding or within 6 months of giving birth in women of childbearing age
  • both escitalopram and sertraline have already been prescribed

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): NCT03628027


Contacts
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Contact: Phillippa Harrison, BSc 07444742274 phillippa.harrison@kcl.ac.uk
Contact: Roland Zahn 020 7848 0348 roland.zahn@kcl.ac.uk

Locations
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United Kingdom
King's College London, IoPPN Recruiting
London, United Kingdom, SE5 8AF
Contact: Phillippa Harrison    07527952622      
Contact: Roland Zahn       roland.zahn@kcl.ac.uk   
Principal Investigator: Roland Zahn         
Sub-Investigator: Allan H Young         
Sub-Investigator: Mark Ashworth         
Sub-Investigator: Kimberley Goldsmith         
Sub-Investigator: Barbara Barrett         
Sponsors and Collaborators
King's College London
NHS Lambeth Clinical Commissioning Group
EMIS PLC
D'Or Institute for Research and Education
Investigators
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Principal Investigator: Roland Zahn Senior Clinical Lecturer, Honorary Consultant Psychiatrist
Study Director: Phillippa Harrison Post-doctoral Research Associate

Publications:
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Responsible Party: Dr Roland Zahn, Senior Clinical Lecturer, Honorary Consultant Psychiatrist, King's College London
ClinicalTrials.gov Identifier: NCT03628027     History of Changes
Other Study ID Numbers: PB-PG-0416-20039
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Dr Roland Zahn, King's College London:
Major Depressive Disorder
Antidepressant Medication
Digital Health
Computerised Decision Support Tool
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs