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.

NCT ID: NCT00775203

Last Updated: 2012-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 412 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2007-11-30

Brief Summary

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).

Detailed Description

This two-arm, multicentre, randomized, placebo-controlled, double-blind, parallel-design study consisted 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 was approximately 11 weeks; the total duration of the randomized phase was 8 weeks (titration: 2 weeks + treatment: 6 weeks).

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Trazodone Contramid Once A Day (OAD)

Group Type: EXPERIMENTAL

Trazodone Hydrochloride (HCl) Extended-Release Tablets

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Trazodone Hydrochloride (HCl) Extended-Release Tablets

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Oleptro

Eligibility Criteria

Inclusion Criteria

• 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.

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.
• 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.
• Previous failure of treatment with trazodone, or previous discontinuation of treatment with trazodone due to Adverse Events.
• Bowel disease causing malabsorption.
• Serious, unstable illnesses during the 3 months before screening including but not limited to: hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic or hematological disease.
• Pregnant or lactating, or is of childbearing potential and not willing to use an approved method of contraception.
• 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 Blood Urea Nitrogen (BUN) and/or creatinine >3 times the upper boundary of the normal range clearance.
• Any other condition that, in the opinion of the investigators, would adversely affect the patient's ability to complete the study or its measures.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Labopharm Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Labopharm Inc.

Locations

Birmingham, Alabama, United States

Mesa, Arizona, United States

Beverly Hills, California, United States

Burbank, California, United States

San Diego, California, United States

Denver, Colorado, United States

Gainesville, Florida, United States

Hialeah, Florida, United States

Jacksonville, Florida, United States

Orlando, Florida, United States

Tampa, Florida, United States

Atlanta, Georgia, United States

Marietta, Georgia, United States

Smyrna, Georgia, United States

Libertyville, Illinois, United States

Indianapolis, Indiana, United States

Overland Park, Kansas, United States

Clementon, New Jersey, United States

Brooklyn, New York, United States

New York, New York, United States

Beachwood, Ohio, United States

Cincinnati, Ohio, United States

Dayton, Ohio, United States

Oklahoma City, Oklahoma, United States

Philadelphia, Pennsylvania, United States

Bellaire, Texas, United States

San Antonio, Texas, United States

Woodstock, Vermont, United States

Kelowna, British Columbia, Canada

Penticton, British Columbia, Canada

Mount Pearl, Newfoundland and Labrador, Canada

Hamilton, Ontario, Canada

Oakville, Ontario, Canada

Gatineau, Quebec, Canada

Saint-Léonard, Quebec, Canada

Sherbrooke, Quebec, Canada

Countries

United States; Canada

References

Sheehan DV, Croft HA, Gossen ER, Levitt RJ, Brulle C, Bouchard S, Rozova A. Extended-release Trazodone in Major Depressive Disorder: A Randomized, Double-blind, Placebo-controlled Study. Psychiatry (Edgmont). 2009 May;6(5):20-33.

Reference Type: RESULT

PMID: 19724732 (View on PubMed)

Related Links

http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=15386

Approved labelling

Other Identifiers

04ACL3-001

Identifier Type: -

Identifier Source: org_study_id