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Trazodone Once a Day in Major Depression Disorder

Information source: Aziende Chimiche Riunite Angelini Francesco S.p.A
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: Trazodone (Drug); Venlafaxine (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Aziende Chimiche Riunite Angelini Francesco S.p.A

Official(s) and/or principal investigator(s):
Filippo Bogetto, MD, Principal Investigator, Affiliation: Department of Neuroscience University of Turin - Italy

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.

Clinical Details

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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Hamilton Depression Rating Scale (HAMD) score

Secondary outcome:

Montgomery-Asberg Depression Rating Scale (MADRS) score

Clinical Global Impression (CGI) Severity of Illness score

Clinical Global Impression (CGI) Global improvement score

Percentage of responders

Percentage of patients with remission

Safety profile of trazodone OAD compared to venlafaxine XR

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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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. Exclusion Criteria:

- 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

- 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.

Locations and Contacts

AKH Wien, Vienna 1090, Austria

Institute für Psychosomatik, Vienna 1010, Austria

Saint Anne, s.r.o., Brno-mesto 60200, Czech Republic

SUPERVIZE, s.r.o., Kutna Hora 284 01, Czech Republic

BIALBI s.r.o., Litomerice 41201, Czech Republic

Fakultni Nemocnice Olomouc, Klinika Psychiatrie, Olomouc 77 900, Czech Republic

MUDr. Eva Soukupová-Psychiatrická praxe, s.r.o., Plzeň 301 00, Czech Republic

NZZ- MUDr. Jaroslav Hronek, psychiatrická ambulance, Plzeň 301 00, Czech Republic

UOPI di Psichiatria Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele, Presidio "Gaspare Rodolico", Catania 95100, Italy

Clinica Psichiatrica Nuovo Ospedale S. Salvatore Università degli Studi del L'Aquila, L'Aquila 67100, Italy

Ospedale Santa Maria della Misericordia Unità di Degenza Psichiatrica-SPDC, Perugia 06132, Italy

Azienda Ospedaliera Sant'Andrea Università La Sapienza Unità Operativa Complessa di Psichiatria, Rome 00189, Italy

AOUS-Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte Clinica Psichiatrica Universitaria, Siena 53100, Italy

Department of Neurosciences University of Turin, Turin 10126, Italy

Quantum Medical Center Srl, Bucharest RO-011426, Romania

Spitalul Clinic de Psihiatrie "Prof. Dr. Al. Obregia"/Sectia 1, Bucharest RO-041914, Romania

Spitalul clinic de psihiatrie "Prof. Dr. Al. Obregia"/Sectia 13, Bucharest RO-041914, Romania

Spitalul Clinc de Urgenta Militar "Dr. Stefan Odobleja", Craiova, Craiova RO-200530, Romania

Spital Clinic de Psihiatrie SOCOLA / Iasi, Iasi RO-700282, Romania

Spitalul de Psihiatrie "Dr. Gh.Preda" Sibiu, Sibiu RO-550082, Romania

Spitalul Clinc Judetean Mures, Centrul de Sanatate Mintala, Targu Mures RO-540096, Romania

MENTUM, s.r.o., Bratislava 82007, Slovakia

Psychiatricka ambulancia, Bratislava 81107, Slovakia

EPAMED, s.r.o., Kosice 4000, Slovakia

Psychiatricka nemocnica, Michalovce 7101, Slovakia

Psycholine, s.r.o., Rimavska Sobota 97901, Slovakia

Psychiatricke oddelenie, NsP sv Barbory Roznava, Roznava 4801, Slovakia

Instituto de Investigacion y Asistencia Psiquiatrica - IIAP, Madrid 28002, Spain

PRAGTIS, s.r.o., Praha 2, Praha 12000, Czech Republic

Psychiatry Trial, s.r.o., Praha 5, Praha 15800, Czech Republic

MEDICAL SERVICES PRAGUE, s.r.o., Praha 6, Praha 160 00, Czech Republic

Neuropsychiatrie s.r.o., Praha 6, Praha 160 00, Czech Republic

Additional Information

Sponsor's website

Starting date: December 2012
Last updated: March 12, 2014

Page last updated: August 23, 2015

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