- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04031157
Controlled Study to Evaluate the Safety and Efficacy of the Predictix Antidepressant Clinician Support Tool
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study will be comprised of two arms:
- PGT arm - Predictix Antidepressant-guided treatment condition
- 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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dekel Taliaz, Dr.
- Phone Number: +972-77- 3352506
- Email: dekel@taliazhealth.com
Study Locations
-
-
-
Tel Aviv, Israel
- Recruiting
- Maccabi Healthcare Services
-
Contact:
- Barak Nada, Mr.
- Phone Number: 972747569300
- Email: nada_b@mac.org.il
-
Principal Investigator:
- Orit Stein, Dr.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male and female at the age of 18 - 75 years old at time of screening.
- MDD diagnosis per DSM V at screening visit or prior to screening visit.
- Rule out other causes of depressive symptoms other than MDD.
- Ability to read, understand and sign an informed consent document
- Female subjects at reproductive age that are tested negative for pregnancy
- Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods during the whole study duration
Exclusion Criteria:
- Patient is currently on an antidepressant treatment.
- Patient is diagnosed with other major psychopathologies (i.e. schizophrenia, bipolar disorder, psychotic depression, geriatric depression).
- 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.
- Patient has participated in another clinical study in the last 30 days preceding this study.
- In the investigator's judgement, patient is not able to provide written informed consent and follow protocol requirements.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PGT arm
Predictix Antidepressant-guided treatment condition
|
Predictix Antidepressant guided treatment
|
No Intervention: soc arm
Standard of Care condition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response rate in the PGT and SOC groups
Time Frame: 12 weeks
|
Overall Response rate with and without the use of the Predictix Antidepressant software tool.
Response is measures as at least 45% reduction in symptoms severity, measured by the Quick Inventory of Depressive Symptomatology (QIDS 16)
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in Quick Inventory of Depressive Symptomatology( QIDS 16) self reported score
Time Frame: 12 weeks
|
Change in total score of the self reported questionnaire.
Total score range is 0-48
|
12 weeks
|
Usability and satisfaction of the Predictix tool
Time Frame: 12 weeks
|
review of completed questionnaires by the treating family physician/general practitioner and psychiatric expert.
Total score rate in 12-84.
(higher value represent better outcome)
|
12 weeks
|
Economic burden* and social impact on patients, employers, the health system and payers
Time Frame: 12 month
|
Based on the analysis of the patients' electronic medical data record retrospectively (6 months prior to enrollment) and following a long-term follow up period
|
12 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CL-02-PRT-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Major Depressive Disorder
-
Shalvata Mental Health CenterUnknownMAjor Depressive DisorderIsrael
-
York UniversityCentre for Addiction and Mental HealthSuspendedDisorder, Major DepressiveCanada
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDDIndia
-
Gangnam Severance HospitalCompletedMajor Depressive Disorder(MDD)Korea, Republic of
-
University College, LondonCompletedUnipolar Major Depressive DisorderUnited Kingdom
-
Fundació Institut de Recerca de l'Hospital de la...Fondo de Investigacion SanitariaUnknown
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDD)India
-
Repurposed Therapeutics, Inc.Unknown
-
GlaxoSmithKlineCompletedMajor Depressive Disorder (MDD)United States
-
AccexibleRecruitingMajor Depressive Disorder (MDD)Spain
Clinical Trials on Predictix Antidepressant
-
Taliaz Ltd.RecruitingMajor Depressive DisorderBelgium, France, Switzerland
-
University of PennsylvaniaNational Institute of Mental Health (NIMH)Completed
-
University Hospital, CaenActive, not recruitingPregnancy Related | Neonatal Hypotonia | Antidepressant Drug Adverse ReactionFrance
-
First Affiliated Hospital of Zhejiang UniversityRecruitingDepressive DisorderChina
-
Peking UniversityRecruiting
-
Cota Inc.Hackensack Meridian Health; MYnd Analytics; Horizon Blue Cross Blue Shield of...Unknown
-
Emory UniversityTerminatedObsessive Compulsive Disorder | Major Depressive Disorder | Post-Traumatic Stress Disorder | Anxiety DisorderUnited States
-
PD Dr. med. Thorsten MikoteitPsychiatrische Dienste Solothurn; Privatklinik WyssRecruitingDepressionSwitzerland
-
Forest LaboratoriesGedeon Richter Ltd.CompletedMajor Depressive DisorderUnited States