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 VisitHAMD-17 Remitters at Each Visit Change in HAMD-17 Depressed Mood Item (Item 1) Score From Baseline to Each Visit Change in Montgomery-Ã…sberg 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-Ã…sberg 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
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