Using Computer Tasks to Predict Response to Antidepressants

NCT02800577 | Completed Phase 1

• 1 other identifier: P1V-DEP-MD01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 10

Brief Summary

In England over 800,000 patients each year are either newly diagnosed with depression or present with a new episode of depression in primary care. The majority of patients do not respond to the first drug prescribed and have to try several different antidepressants before an effective treatment is found. Antidepressants have a slow clinical onset of action, taking 4 to 6 weeks before changes in mood become apparent. No test exists to guide General Practitioners (GPs) as to whether their patient is responding to the prescribed successive treatments. This often results in delays of many months before patients return to good mental health. The GP-ETB is a set of computer-based emotional processing tasks. It was developed and optimised to be sensitive to early changes in emotional bias that are indicative of successful antidepressant treatment. The current investigation is an exploratory study using the GP-ETB. It will test the predictive ability of the GP-ETB with regard to later subjective drug response and nonresponse. The study will recruit depressed patients from primary care settings. There are no study drugs prescribed as part of this clinical investigation. Eligible patients will have been prescribed citalopram by their GP prior to study entry. The decision to initiate treatment with citalopram will be independent of study participation. The duration of the study is 5 months. Each patient will be required to attend 3 visits and total duration of the study for the patient will be 46 weeks. During the visits patients will be asked to complete a variety of questionnaires and GP-ETB tasks on the computer. Sensitivity and specificity data collected during this study will be used to develop a computer algorithm intended to predict response at 46 weeks, based on GP-ETB data collected 1 week after initiation of antidepressant treatment.

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

• Change in Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR) score from baseline (pre-dose of citalopram) to Day 28-42 post first dose of citalopram

  The QIDS-SR is a self report questionnaire and will be completed at baseline pre first dose of citalopram and at day 28-42 post first dose of citalopram. Scores will be compared.

  Baseline (pre first dose of citalopram) to day 28-42 post first dose of citalopram)

• Change in General Practitioner P1vital Oxford Emotional Test Battery (GP-ETB) scores from baseline (pre first dose of citalopram) to Visit 2 (7-9 days post first dose of citalopram)

  Patients will complete the GP-ETB tasks at baseline and 7-9 days post their first dose of citalopram and the scores compared.

  Baseline (pre first dose of citalopram) to day 7-9 post first dose of citalopram)

Secondary Outcomes (3)

• Change in Montgomery-Asberg Depression rating Scale (MADRS) score from baseline (pre-dose of citalopram) to Day 28-42 post first dose of citalopram

  Baseline (pre first dose of citalopram) to day 28-42 post first dose of citalopram)

• Acceptability questionnaire results

  The questionnaire will be completed at Day 28-42 post first dose of citalopram and will measure the participant's experience of the GP-ETB tests performed during the study

• Adverse Events (AEs), Adverse Device Effects (ADEs) and device deficiencies will be recorded at each visit in the participant Case Report Form (CRF)

  AEs will be collected per patient from the baseline visit (day 0), from the time the consent form is signed, until study end (28-42 days post first dose of citalopram) or patient withdrawal.

Study Arms (1)

All participants

OTHER

Study has a single, non-interventional arm where the General Practitioner Emotional Test Battery (GP-ETB) will be administered.

Device: General Practitioner Emotional Test Battery (GP-ETB)

Interventions

General Practitioner Emotional Test Battery (GP-ETB) DEVICE

The GP-ETB (Class I Medical Device) comprises three computer tasks. In the first task, the 'Emotional Categorisation Task' patients are given forty words that might be used to describe them and indicate whether they would 'like' or 'dislike' to be described by a particular word. In the 'Facial Expression Recognition Task' patients are asked to judge whether a briefly displayed face is expressing one of six emotions. In the final task, the 'Emotional Recall Task', the patient should recall as many words as they can from the series of words that were presented in the first task. The patients perform these tasks once before antidepressant treatment and again seven days after treatment begins.

All participants

Eligibility Criteria

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

You may qualify if:

• Male or female and aged between 18 and 65 inclusive.
• Diagnosed by GP with a depressive episode requiring treatment with citalopram (new or recurrent diagnosis).
• Prescribed citalopram by GP for treatment of depression within past 3 days but has not yet started taking medication.
• Is intending to start citalopram treatment within 2 days of Visit 1.
• Fluent English speaker.
• Has not consumed more than 4 units of alcohol in the 24 hours prior to Visit 1 and has not consumed any alcohol in the 8 hours prior to Visit 1.
• Has not smoked tobacco in the 2 hours prior to completing the GP-ETB at Visit 1.
• Has not consumed any beverages containing caffeine for 2 hours prior to completing the GPETB at Visit 1.
• Has not consumed any psychoactive substances for 24 hours prior to Visit 1.
• Willing and able to comply with study procedures, including treatment with citalopram and study prohibitions and restrictions.
• Patient must have signed the informed consent form prior to the first study related procedure indicating they understand the purpose of and procedures required for the study and are willing to participate in the study.

You may not qualify if:

• Pregnant or breastfeeding, or planning to become pregnant during study, as determined through interview with patient.
• Currently taking antidepressant medication.
• Has taken antidepressant medication in the past 3 months.
• Currently taking anti-psychotic or regular sedative medication, or is likely to require these during the study.
• Regular (at least every week) use of recreational drugs including cannabis, as determined through interview with patient.
• History of alcohol or substance dependence within the last 12 months from Visit 1, as assessed using standard screening questions.
• Unlikely to be able to complete GP-ETB test.
• Requires immediate referral to secondary care mental health services.
• Is employed by the investigator or is related to the investigator
• Currently taking part in a drug study or another device study.

Sponsors & Collaborators

• P1vital Products Limited: lead

Study Sites (10)

Cornerstone Practice

March, Cambridgeshire, PE15 9BF, United Kingdom

Location

Knowle House Surgery

Plymouth, Devon, PL5 3JB, United Kingdom

Location

Wareham Surgery

Wareham, Dorset, BH20 4PG, United Kingdom

Location

Oak Street Medical Centre

Norwich, Norfolk, NR3 3DL, United Kingdom

Location

The Surgery

Burnhope, Northumberland, DH7 0BD, United Kingdom

Location

Harbottle Surgery

Morpeth, Northumberland, NE65 7DG, United Kingdom

Location

Rosedale Surgery

Carlton Colville, Suffolk, NR33 8LG, United Kingdom

Location

Atherstone Surgery

Atherstone, Warwickshire, CV9 1EU, United Kingdom

Location

Sherbourne Medical Centre

Royal Leamington Spa, Warwickshire, CV32 4RA, United Kingdom

Location

Bradford Road Medical Centre

Trowbridge, Wiltshire, BA14 9AR, United Kingdom

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Mike Browning, MRCPsych

  P1vital Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: June 15, 2016
• Study Start: June 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2015
• Last Updated: June 15, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (10)