Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

364

participants targeted

Target at P25-P50 for phase_3 major-depressive-disorder

Timeline

Completed

Started Dec 2012

Geographic Reach

6 countries

32 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

Study Start

First participant enrolled

December 1, 2012

Completed

1.3 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2014

Completed

1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed

19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed

Last Updated

December 30, 2015

Status Verified

December 1, 2015

Enrollment Period

1.3 years

First QC Date

March 12, 2014

Last Update Submit

December 29, 2015

Conditions

Major Depressive Disorder

Keywords

TrazodoneVenlafaxineMajor depressive disorder

Outcome Measures

Primary Outcomes (1)

Hamilton Depression Rating Scale (HAMD) score
Mean change from baseline (Day 0) in HAMD score at Day 56.
Day 56

Secondary Outcomes (6)

Montgomery-Asberg Depression Rating Scale (MADRS) score
Day 56
Clinical Global Impression (CGI) Severity of Illness score
Day 56
Clinical Global Impression (CGI) Global improvement score
Day 56
Percentage of responders
Day 56
Percentage of patients with remission
Day 56
+1 more secondary outcomes

Study Arms (2)

Trazodone

EXPERIMENTAL

300 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.

Drug: Trazodone

Venlafaxine XR

ACTIVE COMPARATOR

75 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.

Drug: Venlafaxine

Interventions

TrazodoneDRUG

Trazodone

VenlafaxineDRUG

Venlafaxine XR

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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;
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);
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.

You may not qualify if:

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;
+18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Aziende Chimiche Riunite Angelini Francesco S.p.Alead

Study Sites (32)

Institute für Psychosomatik

Vienna, 1010, Austria

Location

AKH Wien

Vienna, 1090, Austria

Location

PRAGTIS, s.r.o.

Prague, Prague, 12000, Czechia

Location

Psychiatry Trial, s.r.o.

Prague, Prague, 15800, Czechia

Location

MEDICAL SERVICES PRAGUE, s.r.o.

Prague, Prague, 160 00, Czechia

Location

Neuropsychiatrie s.r.o.

Prague, Prague, 160 00, Czechia

Location

Saint Anne, s.r.o.

Brno-mesto, 60200, Czechia

Location

SUPERVIZE, s.r.o.

Kutná Hora, 284 01, Czechia

Location

BIALBI s.r.o.

Litoměřice, 41201, Czechia

Location

Fakultni Nemocnice Olomouc, Klinika Psychiatrie

Olomouc, 77 900, Czechia

Location

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

Pilsen, 301 00, Czechia

Location

NZZ- MUDr. Jaroslav Hronek, psychiatrická ambulance

Pilsen, 301 00, Czechia

Location

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

Catania, Catania, 95100, Italy

Location

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

L’Aquila, L'Aquila, 67100, Italy

Location

Ospedale Santa Maria della Misericordia Unità di Degenza Psichiatrica-SPDC

Perugia, Perugia, 06132, Italy

Location

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

Rome, Rome, 00189, Italy

Location

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

Siena, Siena, 53100, Italy

Location

Department of Neurosciences University of Turin

Turin, Turin, 10126, Italy

Location

Quantum Medical Center Srl

Bucharest, RO-011426, Romania

Location

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

Bucharest, RO-041914, Romania

Location

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

Bucharest, RO-041914, Romania

Location

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

Craiova, RO-200530, Romania

Location

Spital Clinic de Psihiatrie SOCOLA / Iasi

Iași, RO-700282, Romania

Location

Spitalul de Psihiatrie "Dr. Gh.Preda" Sibiu

Sibiu, RO-550082, Romania

Location

Spitalul Clinc Judetean Mures, Centrul de Sanatate Mintala

Târgu Mureş, RO-540096, Romania

Location

Psychiatricka ambulancia

Bratislava, 81107, Slovakia

Location

MENTUM, s.r.o.

Bratislava, 82007, Slovakia

Location

EPAMED, s.r.o.

Košice, 4000, Slovakia

Location

Psychiatricka nemocnica

Michalovce, 7101, Slovakia

Location

Psycholine, s.r.o.

Rimavská Sobota, 97901, Slovakia

Location

Psychiatricke oddelenie, NsP sv Barbory Roznava

Rožňava, 4801, Slovakia

Location

Instituto de Investigacion y Asistencia Psiquiatrica - IIAP

Madrid, 28002, Spain

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

TrazodoneVenlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyridonesPyridinesCyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsPhenethylaminesEthylaminesAminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsLipids

Study Officials

Filippo Bogetto, MD
Department of Neuroscience University of Turin - Italy
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 12, 2014

First Posted

March 13, 2014

Study Start

December 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

December 30, 2015

Record last verified: 2015-12

Locations

AU(2)IT(6)RO(7)CZ(10)ES(1)SL(6)

Trazodone Once a Day in Major Depression Disorder

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Trazodone

Venlafaxine XR

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (32)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Trazodone

Venlafaxine XR

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (32)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations