Using Computer Tasks to Predict Response to Antidepressants
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      The study is an exploratory, single arm, multi-centre, clinical investigation of a medical
      device. The study consists of a recruitment period followed within 3 days by the first study
      visit. After a GP has decided to prescribe citalopram for depression, GP assesses patient for
      suitability for study and provides a brief explanation of study to potentially suitable
      patient. Patient signs pre-study consent form agreeing to being contacted by researcher from
      the same or another GP surgery and agreeing not to take their first dose of citalopram until
      after their first study visit.

      Recruitment and pre-screening Main study Patient Information Sheet/Informed Consent Form
      (PIS/ICF) will be provided. Researcher will contact patient and book the Visit 1 within 3
      days from GP visit.

      At Visit 1, patients will be screened and eligible patients will be enrolled in the study.
      Visit 1 procedures include:

        -  Informed Consent

        -  Demographics

        -  Review of other medication

        -  Brief medical history including depression history (if applicable)

        -  Entry criteria check and enrolment into study

        -  Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR)

        -  Montgomery-Åsberg Depression Rating Scale (MADRS)

        -  Beck Depression Inventory®II (BDI-II)

        -  GP-ETB (set of computer tasks)

        -  Review of Adverse Events (AEs) and Adverse Device Effects (ADEs) and device deficiencies
           Patients will return approximately 1 week later for Visit 2 and will complete a variety
           of questionnaires and assessments:

        -  QIDS-SR

        -  BDI-II

        -  GP-ETB

        -  Assessment of compliance with study prohibitions and restrictions

        -  Changes to antidepressant medication since last visit (e.g. increased dose, change of
           drug)

        -  Concordance with prescribed antidepressant medication, as determined through interview
           with patient

        -  Review of other medication

        -  Review of AEs, ADEs and device deficiencies Visit 3 will be scheduled to take place 46
           weeks after the first dose of citalopram. The following questionnaires and assessments
           will be completed:

        -  QIDS-SR

        -  MADRS

        -  BDI-II

        -  Acceptability questionnaire(s) relating to use of GP-ETB (patient and researcher)

        -  Assessment of compliance with study prohibitions and restrictions

        -  Changes to antidepressant medication since last visit (e.g. increased dose, change of
           drug)

        -  Concordance with prescribed antidepressant medication, as determined through interview
           with patient

        -  Review of other medication

        -  Review of AEs, ADEs and device deficiencies At the end of the visit, patients will be
           considered to have completed the study.

      Emotional Test Battery (GP-ETB) tasks: The GP-ETB is a series of computerised tasks during
      which participants must respond by button press to pictures (e.g. pictures of faces) or words
      presented on the screen. Some of the pictures are mildly emotional (e.g. a fearful face).
      Response bias for each Participant choice and reaction times are measured during the
      following tasks: Emotional Categorisation Task (ECAT) Number of words categorised as liked
      and disliked

      % accuracy for each condition, Reaction time for each condition Emotional Recall Task (EREC)
      Total number of words recalled for each valence (positive, negative) Number of commission
      errors

      Facial Expression Recognition Task (FERT):

        -  accuracy of recognition of each emotion (happiness, fear, anger, disgust, surprise,
           sadness, neutral)

        -  mis-classifications for each emotion Individual average reaction time for correct
           answers in each emotion Reaction time for all emotions Target sensitivity for each
           emotion Response bias for each emotion Questionnaires and rating scales: The
           questionnaires and rating scales used in the current study, except the acceptability
           questionnaires relating to use of GP-ETB (patient and researcher), are all validated and
           commonly used in experimental medicine studies.

      The acceptability questionnaires relating to use of GP-ETB were created specifically for this
      study to obtain a data set for analysis of GP-ETB user satisfaction.
    

Intervention name(s): General Practitioner Emotional Test Battery (GP-ETB)
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment