The main objective of this study is to determine whether use of the PReDicT Test to direct antidepressant treatmentresults in an increased proportion of depressed patients showing a response to treatment at week 8 compared toTreatment as Usual (TaU…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Endpoint
* Change in QIDS-SR-16 score from week 0 (baseline) to week 8. [Quick Inventory
of Depressive Symptomology - Self Report]
Secondary outcome
Secondary Objectives:
* To compare the change from in QIDS-SR-16 score at baseline in to QIDS-SR-16
score QIDS-SR-16 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.
* 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 score.
o MADRS: Montgomery*Åsberg Depression Rating Scale.
* 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 QIDS-SR-16
score of 5 or less.
* 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 MADRS score
of 7 or less.
* To compare the change from the QIDS-SR-16 score at baseline to the QIDS-SR-16
scorein 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.
* To compare the change from QIDS-SR-16 score at baselinebaseline in to
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.
Health Economic Objectives
* To determine the impact on societal costs and cost-effectiveness/cost-utility
of the PReDicT Test intervention in
comparison to TaU over 24 weeks.
* To determine the impact on societal costs and cost-effectiveness/cost-utility
of the PReDicT Test intervention in
comparison to TaU over 48 weeks.
Acceptability and Implementation Objectives
* To obtain further feasibility data, from depressed patients, prescribing
physicians and support research staff to
improve the implementation of the PReDicT Test in clinical care.
* To assess the acceptability and perceived value of the PReDicT Test to
depressed patients, prescribing physicians
and support research staff, in order to optimise its implementation in each
country.
Exploratory Objectives
* 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.
o GAD-7: Generalised Anxiety Disorder Questionnaire, 7 item version.
* 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.
* 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.
* 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.
o Social and occupational functioning will be assessed by SAS-SR (screener
version).
o SAS-SR: Social Adjustment Scale * Self-Report (screener version).
o Social withdrawal measured with a smartphone app (BeHapp).
Safety Objective
* To obtain evidence as required by medical devices legislation that the
PReDicT Test is safe for use in primary care.
Background summary
From the time a patient starts taking an antidepressant medication, it takes
4-6 weeks before a physician can detect whether the treatment is working. In
contrast, the 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. If the PReDicT Test indicates
that a patient is not responding to treatment, the treatment may be altered at
the 7-9 day time point, rather than waiting the 4-6 weeks it currently takes
before a physician can detect whether the treatment is
working. By assessing treatment response at 7-9 days instead of 4-6 weeks, the
PReDicT Test may reduce the time between start of treatment and eventual
improvement in mood. The hypothesis is that use of the PReDicT Test to guide
treatment will result in a higher
proportion of patients responding to treatment at week 8 than those receiving
Treatment as Usual (TaU).
Study objective
The main objective of this study is 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
Treatment as Usual (TaU).
Study design
The study is divided into an 8 to 10 week clinical phase and a 40 week follow
up phase.
Clinical Phase
Potential participants with symptoms of depression will visit their GP. If
their physician decides to prescribe an SSRI
medication (excluding fluoxetine) to treat their depression they can be
considered for the study. Patients who are
interested in taking part in the study will be provided with information on the
study and will be invited to attend a
screening visit.
All participants will attend a screening visit. Those meeting the study entry
criteria will complete the PReDicT Test
during the visit and will be randomised by an electronic Patient Reported
Outcomes (ePRO) system to receive either
treatment directed by the PReDicT Test (PReDicT arm) or TaU (TaU arm).
* Participants in the PReDicT arm will complete the PReDicT Test again at week
1. If the PReDicT Test indicates nonresponse
to drug the participant will also complete the PReDicT Test at week 2. PReDicT
Test results will be provided
to the prescribing physician for participants in the PReDicT arm.
Antidepressant treatment should be changed by the
prescribing physician (in accordance with locally appropriate guidelines and
clinical judgement) when the PReDicT
Test indicates non-response to drug.
* Participants in the TaU arm will complete the PReDicT Test again at week 1.
PReDicT Test results will not be
provided to the prescribing physician for participants in the TaU arm. Any
change made to treatment by the prescribing
physician will be based only on TaU (e.g. a change in drug treatment due to
undesirable side effects).
During the clinical phase, participants will attend between 2 and 4 study
visits, depending on their study arm and their
response to treatment. Some of these visits may be conducted by telephone.
Participants will also complete weekly
online questionnaires from home.
At week 8 all participants will undergo clinical evaluation of their response
to treatment using questionnaires and
assessments. They will also be asked to complete a Patient Acceptability
Questionnaire.
Participants can opt in for an additional measurement of social withdrawal with
a smartphone app (BeHapp).
Follow-Up Phase
During the follow-up phase participants will complete online questionnaires
from home every 4 weeks over a 40 week
period. Clinic visits will not be required during the follow-up phase. In line
with the clinical phase participants can opt in for an additional measurement
of social withdrawal with a smartphone app (BeHapp).
Intervention
The intervention consists in using the PReDicT test to guide antidepressant
treatment.
Study burden and risks
Like all medical tests, the PReDicT Test will not be 100% accurate. This means
that for some people, it may say that
a medicine is not working when it actually is working. In this case, patients
in the PReDicT treatment group may have
an effective medicine changed and it is possible that they will not respond to
the new medicine. Balancing this risk, any treatment for depression may or may
not work for an individual patient and, at the moment, there is no good way of
knowing whether a particular treatment will work for any individual patient.
The purpose of this study is to test whether, on average, using the PReDicT
test helps GPs to start an effective treatment earlier. This risk will be
clearly described in the PIS so potential participants are aware of it before
enrolment in the study, The risk is also time
limited-- the clinical phase of the study will last 8 weeks so if a patient is
not responding to a treatment the GP will
have the opportunity to make further changes to the treatment after the
clinical phase has ended. Indeed, if the GP
thinks it is in the patient's best interests to change the treatment earlier,
treatment can be altered within the study
period without the patient being withdrawn.
To date, there have not been any reported safety issues with the PReDicT Test
or similar computer systems made by
the same company. The computer tasks include displaying emotional stimuli (for
example faces which look sad)
which might possibly affect patients* mood. The researcher will discuss this
possibility with patients and if they are
concerned they will not have to take part in the study.
The study asks that patients do not start taking their medicine for depression
until they have finished Visit 1 of the
study, which may mean waiting up to 7 days after their GP prescribes the
medication. If the patient or GP feel that it is
important for the patient to start the medication before this, then the patient
should not take part in this study and
should start the medicine immediately.
If important new information is learnt about possible risks or other
information that might affect the patient*s
willingness or ability to continue in the study, then researchers will tell
patients about it, via the site staff and/or Patient
Information Sheet.
Site staff will ask patients to report possible side effects, other health
changes and/or changes to medical treatments
to the researcher. These will be collected on a eCRF.
Manor House, Howbery Park 1
Wallingford, Oxfordshire OX10 8BA
GB
Manor House, Howbery Park 1
Wallingford, Oxfordshire OX10 8BA
GB
Listed location countries
Age
Inclusion criteria
- Male or female and aged between 18 and 65 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
the 7 days prior to Visit 1, but has not yet started taking the 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. Participants who are taking or have taken antidepressant medication for treatment of a different condition at a dose which does not have an antidepressant effect are eligible for inclusion.
- Requires immediate referral to alternative mental health services (e.g.
where patient seen in primary care is referred to secondary care services).
- Presents to a physician with significant current suicidal intent requiring
enhanced care.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02790970 |
| CCMO | NL58027.029.16 |