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.

Completed · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

The purpose of this study was to demonstrate efficacy, safety and clinical benefit of Trazodone Contramid® OAD (Once A Day) in the treatment of Unipolar Major Depressive Disorder (MDD).

Key facts

Study ID

NCT00775203

Run by

Labopharm Inc.

People needed

412

Starts

2007-06-01

Expected to finish

2007-11-01

Last updated by the study team

2012-04-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females.
• Aged 18 years or older.
• Fulfills Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for Unipolar Major Depressive Disorder (MDD) (Axis I) as confirmed by the Mini-International Neuropsychiatric Interview (MINI).
• The primary DSM-IV Axis I diagnosis should be MDD (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.
• Oral and written language comprehension at a level sufficient to comply with the protocol and to complete study-related materials.
• Sign and date a written Informed Consent Form (ICF) approved by a Research Ethic Board (REB) which has also been signed and dated by the Investigator prior to study participation.

You may not qualify if…

• 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.
• A history of seizures other than pediatric febrile seizure.
• A history of cardiac arrythmias requiring therapy.
• A history of myocardial infarction within 1 year before screening.
• Clinically significant abnormal findings of Electrocardiography (ECG), laboratory parameters.
• Unwilling to discontinue use of any antidepressants, including herbal remedies, for a minimum of 5 drug half-lives prior to screening.
• Unwilling to discontinue use of prohibited medications for a minimum of 5 drug half-lives prior to screening.
• Treatment within the last 3 weeks with Monoamine Oxidase (MAO) inhibitors.
• Use of the following concomitant treatment during the study:
• medications causing QT prolongation (e.g. amiodarone, droperidol, erythromycin).
• medications causing PR prolongation (e.g. digoxin).
• Anti -psychotics (e.g. haloperidol).
• protease inhibitors such as ritonavir and indinavir.
• Hormonal treatment (e.g. estrogen, oral contraceptives) which has started within 3 months of study entry.
• Treatment with another investigational agent within the last 30 days.
• Known and documented allergy to trazodone or any structurally similar drugs.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Mesa, Arizona, United States
• Study site — Beverly Hills, California, United States
• Study site — Burbank, California, United States
• Study site — San Diego, California, United States
• Study site — Denver, Colorado, United States
• Study site — Gainesville, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Smyrna, Georgia, United States
• Study site — Libertyville, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Overland Park, Kansas, United States
• Study site — Clementon, New Jersey, United States
• Study site — Brooklyn, New York, United States
• Study site — New York, New York, United States
• Study site — Beachwood, Ohio, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Dayton, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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