The Antidepressant Advisor Study

NCT03628027 | Unknown Phase 2 DMC

• 1 other identifier: PB-PG-0416-20039
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; Antidepressant Medication; Digital Health; Computerised Decision Support Tool

Outcome Measures

Primary Outcomes (1)

• Self-Rated Quick Inventory of Depressive Symptomatology (QIDS-SR16)

  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.

  16 weeks

Secondary Outcomes (4)

• Montgomery Asberg Depression Rating Scale (MADRS)

  16 weeks

• Clinical Global Impression

  16 weeks

• Generalised Anxiety Disorder (GAD-7)

  16 weeks

• Body Mass Index (BMI)

  16 weeks

Other Outcomes (15)

• Recruitment Rate

  Through study completion, an average of 16 months

• Lost to Follow-up Rate

  Through study completion, an average of 16 months

• Adverse Event Rate

  Through study completion, an average of 16 months

Study Arms (2)

Treatment Algorithm

EXPERIMENTAL

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

Treatment-as-usual

NO INTERVENTION

The treatment-as-usual arm will comprise GPs prescribing antidepressants and providing care as they typically would.

Interventions

Computerised decision support algorithm DEVICE

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.

Treatment Algorithm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• NHS Lambeth Clinical Commissioning Group: collaborator
• EMIS PLC: collaborator
• D'Or Institute for Research and Education: collaborator

Study Sites (1)

King's College London, IoPPN

London, SE5 8AF, United Kingdom

RECRUITING

Related Publications (7)

• NICE. Depression: The treatment and management of depression in adults. The British Psychological Society and The Royal College of Psychiatrists; 2010.

  BACKGROUND

• Symons L, Tylee A, Mann A, Jones R, Plummer S, Walker M, Duff C, Holt R. Improving access to depression care: descriptive report of a multidisciplinary primary care pilot service. Br J Gen Pract. 2004 Sep;54(506):679-83.

  PMID: 15353054 BACKGROUND

• Kurian BT, Trivedi MH, Grannemann BD, Claassen CA, Daly EJ, Sunderajan P. A computerized decision support system for depression in primary care. Prim Care Companion J Clin Psychiatry. 2009;11(4):140-6. doi: 10.4088/PCC.08m00687.

  PMID: 19750065 BACKGROUND

• Rollman BL, Hanusa BH, Lowe HJ, Gilbert T, Kapoor WN, Schulberg HC. A randomized trial using computerized decision support to improve treatment of major depression in primary care. J Gen Intern Med. 2002 Jul;17(7):493-503. doi: 10.1046/j.1525-1497.2002.10421.x.

  PMID: 12133139 BACKGROUND

• Lythe KE, Moll J, Gethin JA, Workman CI, Green S, Lambon Ralph MA, Deakin JF, Zahn R. Self-blame-Selective Hyperconnectivity Between Anterior Temporal and Subgenual Cortices and Prediction of Recurrent Depressive Episodes. JAMA Psychiatry. 2015 Nov;72(11):1119-26. doi: 10.1001/jamapsychiatry.2015.1813.

  PMID: 26445229 BACKGROUND

• Harrison P, Carr E, Goldsmith K, Young A, Ashworth M, Fennema D, Duan S, Barrett BM, Zahn R. Antidepressant Advisor (ADeSS): a decision support system for antidepressant treatment for depression in UK primary care - a feasibility study. BMJ Open. 2023 Mar 3;13(3):e060516. doi: 10.1136/bmjopen-2021-060516.

  PMID: 36868594 DERIVED

• Harrison P, Carr E, Goldsmith K, Young AH, Ashworth M, Fennema D, Barrett B, Zahn R. Study protocol for the antidepressant advisor (ADeSS): a decision support system for antidepressant treatment for depression in UK primary care: a feasibility study. BMJ Open. 2020 May 24;10(5):e035905. doi: 10.1136/bmjopen-2019-035905.

  PMID: 32448796 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Roland Zahn

  Senior Clinical Lecturer, Honorary Consultant Psychiatrist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roland Zahn

CONTACT

020 7848 0348; adess@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinical Lecturer, Honorary Consultant Psychiatrist

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 14, 2018
• Study Start: August 1, 2018
• Primary Completion: April 1, 2021
• Study Completion: July 1, 2021
• Last Updated: July 30, 2020

Record last verified: 2020-07

Locations

GB (1)