Major Depressive DisorderNCT04031157
Controlled Study to Evaluate the Safety and Efficacy of the Predictix Antidepressant Clinician Support Tool
A study testing Predictix Antidepressant in people with Major Depressive Disorder, run by Taliaz Ltd. at 2 sites in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Predictix Antidepressant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 2 sitesIsrael
- Study dates
- 1 Jan 2018to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Maccabi healthcare services
Tel Aviv
Barak h Nada, 972747569300 ext. 972747569300, nada_b@mac.org.il
Orit h Stein, Dr.
- Recruiting
Maccabi healthcare services
Tel Aviv
Barak Nada, Mr., 972747569300, nada_b@mac.org.il
Orit Stein, Dr.
About this study
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
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Predictix Antidepressant
- Keywords
- MDD
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Predictix AntidepressantDevice
Predictix Antidepressant guided treatment
| Study group | Role | What they receive |
|---|---|---|
| PGT arm | Experimental | Predictix Antidepressant-guided treatment condition Receives: Device: Predictix Antidepressant |
| soc arm | No intervention | Standard of Care condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response rate in the PGT and SOC groups
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)
Measured: 12 weeks
Secondary outcomes (3)
Change from baseline in Quick Inventory of Depressive Symptomatology( QIDS 16) self reported score
Change in total score of the self reported questionnaire. Total score range is 0-48
Measured: 12 weeks
Usability and satisfaction of the Predictix tool
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)
Measured: 12 weeks
Economic burden* and social impact on patients, employers, the health system and payers
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
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start1 Jan 2018
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taliaz Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031157
- Sponsor's protocol ID
- CL-02-PRT-02
- Status last verified
- Jul 2019
- First submitted
- 14 Jul 2019
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04031157
- Acronym / sponsor ID
- CL-02-PRT-02
- Conditions
- Major Depressive Disorder
- Keywords
- MDD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Taliaz Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 24 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PGT arm | Experimental | Device: Predictix AntidepressantPredictix Antidepressant-guided treatment condition |
| soc arm | No intervention | –Standard of Care condition |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Predictix AntidepressantPredictix Antidepressant guided treatment | Device | PGT arm |
Primary outcome
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)
3 secondary outcomes
Change from baseline in Quick Inventory of Depressive Symptomatology( QIDS 16) self reported score
Time frame: 12 weeks
Usability and satisfaction of the Predictix tool
Time frame: 12 weeks
Economic burden* and social impact on patients, employers, the health system and payers
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Predictix Antidepressant in people with Major Depressive Disorder, run by Taliaz Ltd. at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dekel Taliaz, Dr. (+972-77- 3352506, dekel@taliazhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response rate in the PGT and SOC groups (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.