Clinical trial NCT04138290: Post Marketing Study for the Evaluation of Predictix Antidepressant Clinician Software Support Tool in Prescribing Antidepressant Medication/s for the Treatment of Patients Suffering From Major Depressive Disorder
Official title: A Prospective Post Marketing Surveillance Study Study for the Evaluation of the Safety and Efficacy of the Predictix Antidepressant (PAD) Clinician Software Support Tool in Prescribing Antidepressant Medication/s for the Treatment of Patients Suffering From Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Major Depressive Disorder
Lead sponsor: Taliaz Ltd.
Sponsor class: INDUSTRY
First posted: 2019-10-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study is designed as an open label, one arm study
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study is designed as an open label, one arm study. Up to 30 eligible patients will be enrolled, for whom the Predictix Antidepressant Software tool will be used when prescribed with a medication for their Major Depressive Disorder, by their treating physician.

Visits will include the completion of several questionnaires designed to answer the study objectives, either as self-reported by the subjects and/ or by the clinician.

Detailed description: The study will enroll up to 30 eligible patients, for whom the Predictix Antidepressant Software tool will be used when prescribed with a medication for their Major Depressive Disorder, by their treating physician.

A treatment cycle will include four to five visits: Information consent and oral sampling, Baseline, 4 and 8 weeks. At least one completed cycle per patient is required for a patient to be included in the analysis as study completed.

The treating physician will review and approve each subject's eligibility prior to his/ her entrance to the study and will review the Predictix Antidepressant software tool report prior to treatment start.

Visits will include the completion of the Taliaz Ltd. Physician Form and several questionnaires designed to answer the study objectives Usability and satisfaction questionnaire/s will be analyzed for Usefulness, Satisfaction, Ease of Use and Learnability of the system.

Eligibility criteria: Inclusion Criteria:

* Male and female at the age of 18 - 75 years old
* Indication of MDD diagnosis per DSM V
* Rule out other causes of depressive symptoms other than MDD apart from General Anxiety Disorder as authentified by the MINI\*) (by Sheehan and Lecrubier ).

  \*Up to a maximum of 15 completed GAD pts
* Ability to read, understand and sign an informed consent document

Exclusion Criteria:

* Patient is diagnosed with other major psychopathologies (i.e. schizophrenia, bipolar disorder, psychotic depression, geriatric depression)
* Patient requires antipsychotic medication or mood stabilizers
* Patient is at substantial suicidal risk as judged by the treating physician
* Patient has attempted suicide in the past year.
* Patient has any current unstable medical condition or surgical illness
* Patient has history of seizure or convulsions.
* Patient has history of drug abuse or alcoholism in the last 6 months
* Inadequate communication with the patient
* In the investigator's judgement, patient is not able to provide written informed consent
* Pregnant women

Primary outcomes:
measure: success rate of the Predictix tool
timeFrame: 8 weeks
Secondary outcomes:
measure: Usability
timeFrame: 8 weeks
Other outcomes:
measure: To evaluate the effect of device use on patients' care outcomes in terms of economic burden and social impact
timeFrame: 8 weeks
Locations:
city: Paris
country: France
facility: Hospital Pitié Salpétrière
Study officials:
References: