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.

NCT00775203 | Completed Phase 3 Results

• 1 other identifier: 04ACL3-001
• Study Type: interventional
• Target: 412
• Locations: 2 countries
• Sites: 36

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).

Conditions

Major Depressive Disorder

Keywords

Unipolar

Outcome Measures

Primary Outcomes (1)

• Change in Hamilton Depression Scale (HAMD-17) Total Score From Baseline

  The Hamilton Depression Rating Scale 17 items \[HAMD-17\] is a 17-item scale that evaluates depressed mood, vegetative and cognitive symptoms of depression, and co-morbid anxiety symptoms. The 17 items are rated on either a 5-point (0-4) or a 3-point (0-2) scale. In general, the 5 point scale items use a rating of 0=absent; 1=doubtful to mild; 2=mild to moderate; 3=moderate to severe; 4=very severe. The 3-point scale items use a rating of 0=absent; 1=probable or mild; 2=definite. The total HAMD-17score ranges from 0 (not ill) to 52 (severely ill).

  Baseline to Week 8

Secondary Outcomes (13)

• HAMD-17 Responders at Each Visit

  Weeks 1, 2, 3, 4, 6, 8

• HAMD-17 Remitters at Each Visit

  Weeks 1, 2, 3, 4, 6, 8

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

  Baseline to Weeks 1, 2, 3, 4, 6, 8

• Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline

  Baseline to Week 8

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

  Baseline to Weeks 1, 2, 3, 4, 6, 8

Study Arms (2)

Trazodone Contramid Once A Day (OAD)

EXPERIMENTAL

Drug: Trazodone Hydrochloride (HCl) Extended-Release Tablets

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Trazodone Hydrochloride (HCl) Extended-Release Tablets DRUG

Also known as: Oleptro

Trazodone Contramid Once A Day (OAD)

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Labopharm Inc.: lead

Study Sites (36)

Unknown Facility

Birmingham, Alabama, 35216, United States

Location

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Mesa, Arizona, 85206-4616, United States

Location

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Beverly Hills, California, 90210, United States

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Burbank, California, 91506, United States

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San Diego, California, 92108, United States

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Denver, Colorado, 80212, United States

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Gainesville, Florida, 32607, United States

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Hialeah, Florida, 33013, United States

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Jacksonville, Florida, 32216, United States

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Orlando, Florida, 32806, United States

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Tampa, Florida, 33613, United States

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Atlanta, Georgia, 30328, United States

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Marietta, Georgia, 30060, United States

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Smyrna, Georgia, 30080, United States

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Libertyville, Illinois, 60048, United States

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Indianapolis, Indiana, 46202, United States

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Overland Park, Kansas, 66212, United States

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Clementon, New Jersey, 08021, United States

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Brooklyn, New York, 11235, United States

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New York, New York, 10021, United States

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Beachwood, Ohio, 44122, United States

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Cincinnati, Ohio, 45242, United States

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Dayton, Ohio, 45408, United States

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Oklahoma City, Oklahoma, 73103, United States

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Philadelphia, Pennsylvania, 19149, United States

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Bellaire, Texas, 77401, United States

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San Antonio, Texas, 78229, United States

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Woodstock, Vermont, 05091, United States

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Kelowna, British Columbia, V1Y2H4, Canada

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Penticton, British Columbia, V2A5C8, Canada

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Mount Pearl, Newfoundland and Labrador, A1N1W7, Canada

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Hamilton, Ontario, L8L5G8, Canada

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Oakville, Ontario, L6J3J4, Canada

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Gatineau, Quebec, J9A1K7, Canada

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Saint-Léonard, Quebec, H1S3A9, Canada

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Sherbrooke, Quebec, J1H4J6, Canada

Location

Related Publications (1)

• 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.

  PMID: 19724732 RESULT

Related Links

• Approved labelling

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Trazodone

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridones; Pyridines

Results Point of Contact

• Title: Director of Regulatory Affairs
• Organization: Labopharm Inc.

1 450 686 1017

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 17, 2008
• First Posted: October 20, 2008
• Study Start: June 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: April 27, 2012
• Results First Posted: April 7, 2010

Record last verified: 2012-04

Locations

CA (8); US (28)