Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-25 @ 4:28 PM
Study NCT ID:
NCT04031157
Status:
UNKNOWN
Last Update Posted:
2019-07-24
First Post:
2019-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Controlled Study to Evaluate the Safety and Efficacy of the Predictix Antidepressant Clinician Support Tool
Sponsor:
Taliaz Ltd.
Organization:
Study Overview
Official Title:
A Prospective, Randomized, Controlled Study to Evaluate the Safety and Efficacy of the Predictix Antidepressant Clinician Support Tool in Prescribing Antidepressant Medication for the Treatment of Patients Diagnosed With Major Depressive Disorder
Status:
UNKNOWN
Status Verified Date:
2019-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will compare two groups of patients: a control group of patients treated per the Standard of Care when prescribed with a medication for their Major depression disorder, versus a group of patients that used the Predictix Antidepressant tool when prescribed with a medication for their Major depression disorder by their treating physician. Success will be measured by the number (proportion) of responders per group.
Detailed Description:
The study will be comprised of two arms:
1. PGT arm - Predictix Antidepressant-guided treatment condition
2. SOC (control) arm - Standard of Care condition Eligible subjects will be assigned to one of the study arms at a 1:1 ratio and will be followed for a period of 12 weeks.
An assigned psychiatric expert will review and approve subject's eligibility prior to entrance to the study, as well as, the medication/s prescribed based on the Predictix report prior to treatment start.
During the 12 weeks of follow up , data will be collected at the following timepoints: Screening, Baseline (start of treatment) and at 4, 8 and 12 weeks.
Visits will include the completion of several questionnaires designed to answer the study objectives, either as self-reported by the patients and/ or by the physician.
Depression scores by the Quick Inventory of Depressive Symptomatology (QIDS 16) questionnaire and evaluation of all safety related endpoints will be analyzed following the completion of the 12 weeks visit procedures. In case of a change in treatment, as per the treating physician's decision, a new 12 weeks cycle of data collection will start. Two independent cycles are permitted per patient.
In addition, retrospective (6 months prior to enrollment) and long-term follow up period data (12 months post enrollment) will be analyzed, in order to evaluate the device use effect on patients care outcomes in terms of economic burden and Social impact, on patients, employers, the health care system and payers.
The analysis will be based on both the work productivity and activity impairment questionnaire and the patient's electronic medical data record.
1. PGT arm - Predictix Antidepressant-guided treatment condition
2. SOC (control) arm - Standard of Care condition Eligible subjects will be assigned to one of the study arms at a 1:1 ratio and will be followed for a period of 12 weeks.
An assigned psychiatric expert will review and approve subject's eligibility prior to entrance to the study, as well as, the medication/s prescribed based on the Predictix report prior to treatment start.
During the 12 weeks of follow up , data will be collected at the following timepoints: Screening, Baseline (start of treatment) and at 4, 8 and 12 weeks.
Visits will include the completion of several questionnaires designed to answer the study objectives, either as self-reported by the patients and/ or by the physician.
Depression scores by the Quick Inventory of Depressive Symptomatology (QIDS 16) questionnaire and evaluation of all safety related endpoints will be analyzed following the completion of the 12 weeks visit procedures. In case of a change in treatment, as per the treating physician's decision, a new 12 weeks cycle of data collection will start. Two independent cycles are permitted per patient.
In addition, retrospective (6 months prior to enrollment) and long-term follow up period data (12 months post enrollment) will be analyzed, in order to evaluate the device use effect on patients care outcomes in terms of economic burden and Social impact, on patients, employers, the health care system and payers.
The analysis will be based on both the work productivity and activity impairment questionnaire and the patient's electronic medical data record.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: