Major Depressive DisorderNCT04295941
Long-term Study With Trazodone Once-a-Day
An observational study of Major Depressive Disorder, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 1 site in Bulgaria.
Trial summary
The aim of the present observational study is to assess the clinical response, functional impairment and quality of life in outpatients with Major Depressive Disorder who demonstrated an initial positive response to the acute treatment with Trazodone once-a-day monotherapy, for up to 24 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- TraZODone Hydrochloride 300 MG
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteBulgaria
- Study dates
- 23 Jun 2020to 16 Nov 2021
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients presenting with Major Depressive Disorder who, following an initial positive response to the acute treatment with Trazodone once-a-day monotherapy, will be eligible according to the physician's judgement, to enter the continuation therapy and will be observed up to 24 weeks.
Who may be able to join
- Male and female patients of any ethnic origin ≥18 years old at Baseline. Outpatients who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 or the International Classification of Diseases (ICD)-10 criteria for MDD as their primary diagnosis and presenting with an episode of MDD.
- Patients judged as responders to the acute monotherapy with TzOAD after a minimum of 6 and a maximum of 8 weeks of treatment and who are eligible to continue the assigned monotherapy according to the physician's judgement.
- Patients legally capable of giving their written consent for participation in the study and for personal data processing and willing to comply with all study procedures.
Who cannot join
- Patients that meet any of the contraindications to the administration of TzOAD according to the approved SmPC.
- Patients with previous or current diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, dysthymic or adjustment disorders, mental retardation, organic mental disorders or mental disorders due to a general medical condition.
- Patients with previous or current history of a clinically significant neurological disorder, or any neurodegenerative diseases that might compromise the participation in the study.
- Patients who are, according to the physician's judgement, at serious risk of suicide.
- Patients with substance abuse or dependence (except nicotine dependence), as defined by DSM-5.
- Patients participating in any pharmacological or non-pharmacological interventional study.
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site
Medical Center Hera EOOD - Clinic/Outpatient Facility
Sofia, 1510
About this study
Official title: Long-term Treatment With Trazodone Once-a-Day (TzOAD) in Patients With MDD: an Observational, Prospective Study
The aim of the present observational study is to assess the clinical response, functional impairment and quality of life in outpatients with Major Depressive Disorder who demonstrated an initial positive response to the acute treatment with Trazodone once-a-day monotherapy, for up to 24 weeks.
Read the detailed description
This is an observational, prospective, single group, multicentre, international study.
The present study is planned to assess, in a real-world setting, the long-term clinical response, functional impairment and quality of life in outpatients with Major Depressive Disorder who, according to the physician's judgment, have responded to the acute monotherapy (6 to 8 weeks of treatment) with Trazodone once-a-day and are eligible to continue Trazodone once-a-day monotherapy according to clinical practice.
- Conditions
- Major Depressive Disorder
- Being tested
- TraZODone Hydrochloride 300 MG
- Keywords
- Trazodone once-a-day, Major Depressive Disorder, Long term therapy
- 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.
TraZODone Hydrochloride 300 MGDrug
Oral administration of Trazodone once-a-day.
| Study group | Role | What they receive |
|---|---|---|
| Trazodone once-a-day treated patients | Major Depressive Disorder outpatients who, following an initial positive response to the acute treatment with Trazodone once-a-day monotherapy, will be eligible to enter the continuation therapy and will be observed up to 24 weeks. Receives: Drug: TraZODone Hydrochloride 300 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression-improvement scale responders percentage
The clinical response expressed as CGI-I responders' percentage at 24 (+ 4) weeks.
Measured: 24(+4) weeks
Secondary outcomes (4)
Clinical Global Impression-improvement scale responders percentage
The clinical response expressed as CGI-I responders' percentage at 12 (+ 3) weeks.
Measured: 12 (+ 3) weeks.
Clinical Global Impression-improvement scale responders percentage
The clinical response expressed as CGI-I responders' percentage at 18 (+ 3) weeks.
Measured: 18 (+ 3) weeks
Sheehan Disability Scale score
The functional impairment evaluated over the 24-week period
Measured: 24-week period
EQ-5D-5L Quality of life scale
The quality of life evaluated over the 24-week period
Measured: 24-week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start23 Jun 2020
- Primary completion16 Nov 2021
- Study completion16 Nov 2021
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295941
- Sponsor's protocol ID
- 039(C)WO19201
- Status last verified
- Sep 2022
- First submitted
- 3 Mar 2020
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Treatment With Trazodone Once-a-Day (TzOAD) in Patients With MDD: an Observational, Prospective Study
- ClinicalTrials.gov ID
- NCT04295941
- Acronym / sponsor ID
- 039(C)WO19201
- Conditions
- Major Depressive Disorder
- Keywords
- Trazodone once-a-day, Major Depressive Disorder, Long term therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.AIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 16 Nov 2021 (actual)
- Study completion
- 16 Nov 2021 (actual)
- First posted
- 5 Mar 2020 (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 aim of the present observational study is to assess the clinical response, functional impairment and quality of life in outpatients with Major Depressive Disorder who demonstrated an initial positive response to the acute treatment with Trazodone once-a-day monotherapy, for up to 24 weeks.
Detailed description
This is an observational, prospective, single group, multicentre, international study.
The present study is planned to assess, in a real-world setting, the long-term clinical response, functional impairment and quality of life in outpatients with Major Depressive Disorder who, according to the physician's judgment, have responded to the acute monotherapy (6 to 8 weeks of treatment) with Trazodone once-a-day and are eligible to continue Trazodone once-a-day monotherapy according to clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trazodone once-a-day treated patients | – | Drug: TraZODone Hydrochloride 300 MGMajor Depressive Disorder outpatients who, following an initial positive response to the acute treatment with Trazodone once-a-day monotherapy, will be eligible to enter the continuation therapy and will be observed up to 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients presenting with Major Depressive Disorder who, following an initial positive response to the acute treatment with Trazodone once-a-day monotherapy, will be eligible according to the physician's judgement, to enter the continuation therapy and will be observed up to 24 weeks.
Key inclusion criteria (3 listed)
- Male and female patients of any ethnic origin ≥18 years old at Baseline. Outpatients who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 or the International Classification of Diseases (ICD)-10 criteria for MDD as their primary diagnosis and presenting with an episode of MDD.
- Patients judged as responders to the acute monotherapy with TzOAD after a minimum of 6 and a maximum of 8 weeks of treatment and who are eligible to continue the assigned monotherapy according to the physician's judgement.
- Patients legally capable of giving their written consent for participation in the study and for personal data processing and willing to comply with all study procedures.
Key exclusion criteria (6 listed)
- Patients that meet any of the contraindications to the administration of TzOAD according to the approved SmPC.
- Patients with previous or current diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, dysthymic or adjustment disorders, mental retardation, organic mental disorders or mental disorders due to a general medical condition.
- Patients with previous or current history of a clinically significant neurological disorder, or any neurodegenerative diseases that might compromise the participation in the study.
- Patients who are, according to the physician's judgement, at serious risk of suicide.
- Patients with substance abuse or dependence (except nicotine dependence), as defined by DSM-5.
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 |
|---|---|---|
| TraZODone Hydrochloride 300 MGOral administration of Trazodone once-a-day. | Drug | Trazodone once-a-day treated patients |
Primary outcome
Clinical Global Impression-improvement scale responders percentage
Time frame: 24(+4) weeks
The clinical response expressed as CGI-I responders' percentage at 24 (+ 4) weeks.
4 secondary outcomes
Clinical Global Impression-improvement scale responders percentage
Time frame: 12 (+ 3) weeks.
Clinical Global Impression-improvement scale responders percentage
Time frame: 18 (+ 3) weeks
Sheehan Disability Scale score
Time frame: 24-week period
EQ-5D-5L Quality of life scale
Time frame: 24-week period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
Related trials for Major Depressive Disorder
Recruiting
Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium
Major Depressive Disorder
Enrolling by invitation
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
HIV, HIV - Human Immunodeficiency Virus
RecruitingPhase 3
A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder
Major Depressive Disorder (MDD), Depression in Adults
RecruitingObservational study
The Immunobiological Mechanisms of Depression in Perimenopause
Perimenopause, Major Depressive Episode (MDE)
Not yet recruiting
Effectiveness of Internet-based Unified Protocol (iUP) for Emotional Problems: A Randomized Controlled Trial
Depression - Major Depressive Disorder, Generalised Anxiety Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 1 site in Bulgaria.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impression-improvement scale responders percentage (time frame: 24(+4) 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 21 Sep 2022.