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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.

Information source: Labopharm Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: Trazodone Hydrochloride (HCl) Extended-Release Tablets (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Labopharm Inc.

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).

Clinical Details

Official title: 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.

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in Hamilton Depression Scale (HAMD-17) Total Score From Baseline

Secondary outcome:

HAMD-17 Responders at Each Visit

HAMD-17 Remitters at Each Visit

Change in HAMD-17 Depressed Mood Item (Item 1) Score From Baseline to Each Visit

Change in Montgomery-├ůsberg Depression Rating Scale (MADRS) Total Score From Baseline

Change From Baseline in Clinical Global Impression of Severity (CGI-S) to Each Visit

Clinical Global Impression - Improvement of Illness (CGI-I) Score at Last Study Visit

Patient Global Impression - Improvement of Illness (PGI-I) Score at Last Study Visit

Clinical Global Impression - Improvement of Illness (CGI-I) Responders at Last Study Visit

Patient Global Impression - Improvement of Illness (PGI-I) Responders at Last Study Visit

Overall Quality of Sleep at Each Visit

Trouble Falling Asleep at Each Visit

Awakening During the Night at Each Visit

Discontinuation Due to Lack of Efficacy

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).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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-├ůsberg 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.

Locations and Contacts

Birmingham, Alabama 35216, United States

Mesa, Arizona 85206-4616, United States

Kelowna, British Columbia V1Y2H4, Canada

Penticton, British Columbia V2A5C8, Canada

Beverly Hills, California 90210, United States

Burbank, California 91506, United States

San Diego, California 92108, United States

Denver, Colorado 80212, United States

Gainesville, Florida 32607, United States

Hialeah, Florida 33013, United States

Jacksonville, Florida 32216, United States

Orlando, Florida 32806, United States

Tampa, Florida 33613, United States

Atlanta, Georgia 30328, United States

Marietta, Georgia 30060, United States

Smyrna, Georgia 30080, United States

Libertyville, Illinois 60048, United States

Indianapolis, Indiana 46202, United States

Overland Park, Kansas 66212, United States

Clementon, New Jersey 08021, United States

Brooklyn, New York 11235, United States

New York, New York 10021, United States

New-York, New York 10021, United States

Mount Pearl, Newfoundland and Labrador A1N1W7, Canada

Beachwood, Ohio 44122, United States

Cincinnati, Ohio 45242, United States

Dayton, Ohio 45408, United States

Oklahoma City, Oklahoma 73103, United States

Hamilton, Ontario L8L5G8, Canada

Oakville, Ontario L6J3J4, Canada

Philadelphia, Pennsylvania 19149, United States

Gatineau, Quebec J9A1K7, Canada

Saint-Leonard, Quebec H1S3A9, Canada

Sherbrooke, Quebec J1H4J6, Canada

Bellaire, Texas 77401, United States

San Antonio, Texas 78229, United States

Woodstock, Vermont 05091, United States

Additional Information

Approved labelling

Starting date: June 2007
Last updated: April 24, 2012

Page last updated: August 23, 2015

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