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Major Depressive DisorderPhase 3NCT02086929

Trazodone Once a Day in Major Depression Disorder

A Phase 3 study testing Trazodone and Venlafaxine in people with Major Depressive Disorder, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 32 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study objective is to evaluate the efficacy and safety of trazodone OAD vs venlafaxine extended release (venlafaxine XR) after an 8-week treatment period in patients with major depressive 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?
Trazodone and Venlafaxine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
364 participants
Where
32 sitesin 6 countries
Study dates
Dec 2012to Apr 2014
Phase
Phase 3
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

  • men and women 18-75 years of age (limits included) with no limitation of race;
  • outpatients;
  • major depressive disorder according to DSM-IV criteria as assessed using the MINI International Neuropsychiatric Interview;
  • 17-item HAMD score > 18 at both screening and baseline visits with a decrease not exceeding 20% between screening and baseline;
  • symptoms of depression for at least one month before study entry (screening visit);
  • legally capable to give their consent to participate the study, and available to sign and date the written informed consent prior to the inclusion in the study;
  • women of childbearing potential must agree not to start a pregnancy from the signature of the informed consent up to 30 days after the last administration of the investigational product.

Who cannot join

  • participation in another trial involving any investigational drug during the past 60 days;
  • known hypersensitivity to venlafaxine or trazodone or their excipients;
  • use of venlafaxine or trazodone within the previous six months;
  • acute, or chronic, or recurrent medical conditions that might affect/jeopardize the study results;
  • significant liver disease, defined as active hepatitis or elevated liver enzymes > 3 times the upper boundary of the normal range;
  • significant renal disease, defined as urea and/or creatinine > 3 times the upper boundary of the normal range
Show all 33Show fewer
  • myocardial infarction within 6 months prior to start of the double blind treatment;
  • positive present history of glaucoma;
  • history of risk factors for Torsade de Pointes, such as heart failure, cardiac arrhythmias, bradycardia, cardiac conduction abnormalities, family history of long QT syndrome, cardiac hypertrophy, cardiomyopathy, chronic cardiac insufficiency;
  • values of electrolytes (sodium, potassium, calcium, magnesium, chloride) outside the normal laboratory range and judged clinically relevant by the Investigator;
  • concomitant treatment with drugs known for QT prolongation, or with drugs producing hypokalemia, or diuretics;
  • QTcF values higher than 450 msec in the ECG performed at the screening;
  • history of major depression resistant to medical treatments (previous failure to respond to two consecutive antidepressants of different classes used for a sufficient length of time at appropriate doses);
  • history of seizure events other than a single childhood febrile seizure;
  • history of alcohol or psychoactive substance abuse or addiction (except caffeine or nicotine) during the last year as defined by DSM-IV criteria;
  • positive urine drug screen for CNS-active drugs (cocaine, opioids, amphetamines and cannabinoids) at Visit 1 (screening);
  • acute risk of suicide (HAMD, criterion 3 with a value > 3);
  • presence of any primary psychiatric disorder other than major depression;
  • history or presence of bipolar disorder, any psychotic disorder, mental disorder due to general medical conditions;
  • pregnancy, lactation, or female with a positive urine pregnancy test result at Visit 1 (Screening);
  • electroconvulsive therapy (ECT) within 30 days prior to the screening visit;
  • use of antipsychotic drugs within two months prior to the baseline visit (Visit 2);
  • use of any anxiolytic or sedative hypnotic drug within seven days prior to the baseline (Visit 2) and during the study. Exception is stable low doses of benzodiazepines for insomnia (if taken by the patient more than two weeks before the Treatment Phase);
  • use of any psychotropic drug or substance with central nervous system effects within seven days prior to the baseline visit (Visit 2);
  • use of any non-psychotropic drug with psychotropic effects (e.g. alpha-adrenergic blockers) within seven days prior to the baseline visit (visit 2), unless a stable dose of the drug has been maintained for at least one month (three months for thyroid or hormonal medications) before the baseline visit (visit 2);
  • concomitant treatment with CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, indinavir);
  • hyperthyroidism, even if pharmacologically corrected;
  • start or discontinuation of psychotherapy within 6 weeks prior to screening;
  • clinically significant abnormalities on physical examination, vital signs, ECG, laboratory tests at the screening visit;
  • high blood pressure (supine systolic blood pressure > 160 mmHg or supine diastolic blood pressure > 90 mmHg) at screening or baseline, either untreated or under treatment with antihypertensives
  • inability to comply with the protocol requirements, instructions and study-related restrictions; e.g. uncooperative attitude, inability to return for study-visits, and improbability of completing the clinical study;
  • vulnerable subjects (e.g. persons kept in detention);
  • if subject is the Investigator or his/her deputies, first grade relative, research assistant, pharmacist, study coordinator, other staff of relative thereof directly involved in the conduct of the study.

Trial locations and contacts

32 sites in 6 countries.

32 sites in 6 countries

Czechia10 sites

  • Saint Anne, s.r.o.

    Brno-mesto, 60200

  • SUPERVIZE, s.r.o.

    Kutná Hora, 284 01

  • BIALBI s.r.o.

    Litoměřice, 41201

  • Fakultni Nemocnice Olomouc, Klinika Psychiatrie

    Olomouc, 77 900

  • MUDr. Eva Soukupová-Psychiatrická praxe, s.r.o.

    Pilsen, 301 00

  • NZZ- MUDr. Jaroslav Hronek, psychiatrická ambulance

    Pilsen, 301 00

  • PRAGTIS, s.r.o.

    Prague, Prague, 12000

  • Psychiatry Trial, s.r.o.

    Prague, Prague, 15800

  • MEDICAL SERVICES PRAGUE, s.r.o.

    Prague, Prague, 160 00

  • Neuropsychiatrie s.r.o.

    Prague, Prague, 160 00

Other trials in Czechia

Romania7 sites

  • Quantum Medical Center Srl

    Bucharest, RO-011426

  • Spitalul clinic de psihiatrie "Prof. Dr. Al. Obregia"/Sectia 13

    Bucharest, RO-041914

  • Spitalul Clinic de Psihiatrie "Prof. Dr. Al. Obregia"/Sectia 1

    Bucharest, RO-041914

  • Spitalul Clinc de Urgenta Militar "Dr. Stefan Odobleja", Craiova

    Craiova, RO-200530

  • Spital Clinic de Psihiatrie SOCOLA / Iasi

    Iași, RO-700282

  • Spitalul de Psihiatrie "Dr. Gh.Preda" Sibiu

    Sibiu, RO-550082

  • Spitalul Clinc Judetean Mures, Centrul de Sanatate Mintala

    Târgu Mureş, RO-540096

Other trials in Romania

Italy6 sites

  • UOPI di Psichiatria Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele, Presidio "Gaspare Rodolico"

    Catania, Catania, 95100

  • Clinica Psichiatrica Nuovo Ospedale S. Salvatore Università degli Studi del L'Aquila

    L’Aquila, L'Aquila, 67100

  • Ospedale Santa Maria della Misericordia Unità di Degenza Psichiatrica-SPDC

    Perugia, Perugia, 06132

  • Azienda Ospedaliera Sant'Andrea Università La Sapienza Unità Operativa Complessa di Psichiatria

    Rome, Rome, 00189

  • AOUS-Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte Clinica Psichiatrica Universitaria

    Siena, Siena, 53100

  • Department of Neurosciences University of Turin

    Turin, Turin, 10126

Other trials in Italy

Slovakia6 sites

  • Psychiatricka ambulancia

    Bratislava, 81107

  • MENTUM, s.r.o.

    Bratislava, 82007

  • EPAMED, s.r.o.

    Košice, 4000

  • Psychiatricka nemocnica

    Michalovce, 7101

  • Psycholine, s.r.o.

    Rimavská Sobota, 97901

  • Psychiatricke oddelenie, NsP sv Barbory Roznava

    Rožňava, 4801

Other trials in Slovakia

Austria2 sites

  • Institute für Psychosomatik

    Vienna, 1010

  • AKH Wien

    Vienna, 1090

Other trials in Austria

Spain1 site

  • Instituto de Investigacion y Asistencia Psiquiatrica - IIAP

    Madrid, 28002

Other trials in Spain

About this study

Official title: A Randomized, Double-blind Study Comparing the Efficacy and Safety of Trazodone OAD and Venlafaxine XR in the Treatment of Patients With Major Depressive Disorder.

The study objective is to evaluate the efficacy and safety of trazodone OAD vs venlafaxine extended release (venlafaxine XR) after an 8-week treatment period in patients with major depressive disorder.

Read the detailed description

This randomized, venlafaxine-controlled, double-blind, parallel design study consists of a Pre-Treatment Phase (screening, wash-out) and a double-blind Treatment Phase (randomization to trazodone OAD or to venlafaxine XR, treatment for 8 weeks and tapering for 1 to 3 weeks). During the Pre-Treatment Phase, patients who sign an informed consent form will undergo initial screening. Potential candidates will be instructed to discontinue antidepressants or prohibited medications (wash-out) for a period specific to taper schedule (based on 5 elimination half-lives of the used medication). On the last day of the Pre-Treatment Phase, patients will be evaluated for the final eligibility, and those qualified will be randomly allocated in a 1:1 proportion to trazodone OAD 300 mg/day (1 week of tapering with trazodone OAD 150 mg/day) or to venlafaxine XR 75 mg/day once daily. After 3 and 5 weeks of treatment, subjects will be evaluated for the response. For non responding patients dose increases (in increments of 75 mg/day) will be done till to reach the maximum of 225 mg/day for venlafaxine XR and 450 mg/day for trazodone OAD. Patients non responding to treatment at the final visit will have their study medication tapered from 1 to 3 weeks, according to the maximum dose reached during the study. In order to prevent relapse of depression symptoms, responders at the final visit may continue the treatment. In this case, an unblinded third party Dispenser will open the treatment code and will prescribe the same medication taken by the patients during the trial, according to the formulation available on the market.

Being tested
Trazodone, Venlafaxine
Keywords
Trazodone, Venlafaxine, Major depressive disorder
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.

  • TrazodoneDrug

  • VenlafaxineDrug

Study groups in NCT02086929
Study groupRoleWhat they receive
TrazodoneExperimental300 mg/day for 8 weeks (including 1 week 150 mg/day of dose-titration). After 3 and 5 weeks of treatment, non responders will have dose increases (in increments of 75 mg/day) till to reach the maximum of 450 mg/day. Dosage form: capsule.
Receives: Drug: Trazodone
Venlafaxine XRActive comparator75 mg/die for 8 weeks. After 3 and 5 weeks of treatment, non responders will have dose increases (in increments of 75 mg/day) till to reach the maximum of 225 mg/day. Dosage form: capsule.
Receives: Drug: Venlafaxine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hamilton Depression Rating Scale (HAMD) score

    Mean change from baseline (Day 0) in HAMD score at Day 56.

    Measured: Day 56

Secondary outcomes (6)

  1. Montgomery-Asberg Depression Rating Scale (MADRS) score

    Mean change from baseline (Day 0) in MADRS score at Day 56.

    Measured: Day 56

  2. Clinical Global Impression (CGI) Severity of Illness score

    CGI-Severity of Illness improvement at Day 56.

    Measured: Day 56

  3. Clinical Global Impression (CGI) Global improvement score

    CGI-Global improvement at Day 56.

    Measured: Day 56

  4. Percentage of responders

    Rate of patients with a 50% decrease with respect to baseline on the HAMD score at Day 56.

    Measured: Day 56

  5. Percentage of patients with remission

    Rate of patients with a HAMD score <or= at Day 56.

    Measured: Day 56

  6. Safety profile of trazodone OAD compared to venlafaxine XR

    Safety and tolerability will be assessed through adverse events monitoring, physical examinations and monitoring of vital signs, body weight, clinical laboratory tests, ECG.

    Measured: 11 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2014 (estimated)
  2. Study startDec 2012
  3. Primary completionApr 2014
  4. Study completionApr 2014

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
364 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02086929
Sponsor's protocol ID
039(C)SC11063
Status last verified
Dec 2015
First submitted
12 Mar 2014
Last updated
30 Dec 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trazodone and Venlafaxine in people with Major Depressive Disorder, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 32 sites in 6 countries.

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 7 inclusion and 33 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 30 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Czechia, Romania, Italy, Slovakia, Austria and 1 more country. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Hamilton Depression Rating Scale (HAMD) score (time frame: Day 56). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02086929.

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 30 Dec 2015.

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