A Randomized, Double-Blind, Two-Arm Study Comparing the Efficacy and Safety of Trazodone Contramid® OAD and Placebo in the Treatment of Unipolar Major Depressive Disorder. - Full Text View

Sponsored by:	Labopharm Inc.
Information provided by:	Labopharm Inc.
ClinicalTrials.gov Identifier:	NCT00775203

Purpose

This two-arm, multi-centre, randomized, placebo-controlled, double-blind, parallel-design study will consist of a Baseline Phase (screening and wash-out) and a double-blind Randomized Phase (randomization to Trazodone Contramid® OAD or Placebo). The total study duration including wash-out of prohibited medications is approximately 11 weeks; the total duration of the randomized phase is 8 weeks (titration: 2 weeks + treatment: 6 weeks).

Condition	Intervention	Phase
Major Depressive Disorder	Drug: Trazodone Contramid OAD Drug: Placebo	Phase III

MedlinePlus related topics: Depression

Drug Information available for: Trazodone Trazodone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment

Further study details as provided by Labopharm Inc.:

Primary Outcome Measures:

Change in HAMD-17 total score from baseline (last measurement prior to the first dose at Visit 2) to the end of the study, Visit 8 ( Day R56)

Secondary Outcome Measures:

HAMD:responders;remitters;depressed mood item.MADRS:Change from baseline.CGI-I and PCG-I responders and score at last study visit.CGI-S:Change from baseline.Quality of Sleep Assessment.Discontinuations due to lack of efficacy.Safety parameters.

Enrollment:	412
Study Start Date:	June 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Trazodone Contramid OAD
2: Placebo Comparator	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or females.
Aged 18 years or older.
Fulfills DSM-IV criteria for Unipolar Major Depressive Disorder (MDD) (Axis I) as confirmed by the MINI International Neuropsychiatric Interview.
The primary DSM-IV Axis I diagnosis should be Major Depressive Disorder (296.22, 296.23, 296.32, 296.33); any subject meeting criteria for another, non excluded Axis I disorder, must demonstrate MDD as the primary disorder.
The current episode of MDD should have lasted for a minimum of 1 month, whether the patient has been diagnosed with one single or recurrent episodes.
Presence of dysphoria for most days over the past four weeks.
Montgomery-Åsberg Depression Rating Scale (MADRS) total score of at least 26 at screening and baseline.

Exclusion Criteria:

DSM-IV Major Depressive Disorder Specifiers: [a] With Catatonic Features; [b] With Postpartum Onset; [c] With Seasonal Pattern;
Presence of any of the following DSM-IV Axis I disorders: generalized anxiety disorder, panic disorder, social phobia, obsessive-compulsive disorder, post-traumatic stress disorder, eating disorder, bipolar disorder, alcohol/substance abuse or dependence (caffeine and nicotine allowed), any psychotic disorder.
Depression secondary to stroke, cancer or other severe medical illnesses.
Positive urine drug screen at screening visit.
History or present condition of any DSM-IV Axis II disorder.
History of treatment refractory major depressive episodes defined as incomplete or no therapeutic response to two prior courses of at least one month of conventional antidepressant drug treatment in adequate dosages.
Currently in psychotherapy (at least one session in the past month with a plan for continuing) with a licensed/registered/certified mental health provider, marriage counselor, or family therapist.
Meet criteria for high suicide risk on the MINI suicide scale, or in the opinion of the investigator is inappropriate for the trial due to clinically significant suicidal or homicidal potential.
Require hospitalization for treatment of the current episode of depression.
Uncorrected hypo- or hyperthyroidism.
Hormonal treatment (e.g. estrogen, oral contraceptives) which has started within 3 months of study entry.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00775203

Show 37 Study Locations

Sponsors and Collaborators

Labopharm Inc.

More Information

Responsible Party:	Labopharm Inc. ( Dr Claire Brullé, Chief Medical Officer )
Study ID Numbers:	04ACL3-001
Study First Received:	October 17, 2008
Last Updated:	October 17, 2008
ClinicalTrials.gov Identifier:	NCT00775203
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Labopharm Inc.:

Unipolar

Study placed in the following topic categories:

Depression
Mental Disorders
Trazodone
Mood Disorders

Depressive Disorder, Major
Depressive Disorder
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Serotonin Uptake Inhibitors

Pharmacologic Actions
Serotonin Agents
Pathologic Processes
Therapeutic Uses
Anti-Anxiety Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009