Major Depressive Disorder Clinical Trial
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
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.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | December 2020 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Hospital Pitié Salpétrière | Paris |
Lead Sponsor | Collaborator |
---|---|
Taliaz Ltd. |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | To evaluate the effect of device use on patients' care outcomes in terms of economic burden and social impact | by analyzing the completed Work Productivity and Activity Impairment (WPAI) questionnaire. | 8 weeks | |
Primary | success rate of the Predictix tool | A success will be defined as a score of 3 and below in the total improvement: measured by the CGI last measured value compared to Baseline, as well as a >50% improvement measured by the QIDS16, under a specific medication cycle regimen. | 8 weeks | |
Secondary | Usability | Usability n questionnaire will be analyzed | 8 weeks |
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