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Major Depressive DisorderPhase 3NCT00775203

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.

A Phase 3 study testing Trazodone Hydrochloride (HCl) Extended-Release Tablets in people with Major Depressive Disorder, run by Labopharm Inc. at 36 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Major Depressive Disorder
What is being tested?
Trazodone Hydrochloride (HCl) Extended-Release Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
412 participants
Where
36 sitesin 2 countries
Study dates
Jun 2007to Nov 2007
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.
Show all 32Show fewer
  • 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.

Trial locations and contacts

36 sites in 2 countries.

36 sites in 2 countries

United States28 sites

  • Study site

    Atlanta, Georgia, 30328

  • Study site

    Beachwood, Ohio, 44122

  • Study site

    Bellaire, Texas, 77401

  • Study site

    Beverly Hills, California, 90210

  • Study site

    Birmingham, Alabama, 35216

  • Study site

    Brooklyn, New York, 11235

  • Study site

    Burbank, California, 91506

  • Study site

    Cincinnati, Ohio, 45242

  • Study site

    Clementon, New Jersey, 08021

  • Study site

    Dayton, Ohio, 45408

  • Study site

    Denver, Colorado, 80212

  • Study site

    Gainesville, Florida, 32607

  • Study site

    Hialeah, Florida, 33013

  • Study site

    Indianapolis, Indiana, 46202

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Libertyville, Illinois, 60048

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Mesa, Arizona, 85206-4616

  • Study site

    New York, New York, 10021

  • Study site

    Oklahoma City, Oklahoma, 73103

  • Study site

    Orlando, Florida, 32806

  • Study site

    Overland Park, Kansas, 66212

  • Study site

    Philadelphia, Pennsylvania, 19149

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Diego, California, 92108

  • Study site

    Smyrna, Georgia, 30080

  • Study site

    Tampa, Florida, 33613

  • Study site

    Woodstock, Vermont, 05091

Other trials in United States

Canada8 sites

  • Study site

    Gatineau, Quebec, J9A1K7

  • Study site

    Hamilton, Ontario, L8L5G8

  • Study site

    Kelowna, British Columbia, V1Y2H4

  • Study site

    Mount Pearl, Newfoundland and Labrador, A1N1W7

  • Study site

    Oakville, Ontario, L6J3J4

  • Study site

    Penticton, British Columbia, V2A5C8

  • Study site

    Saint-Léonard, Quebec, H1S3A9

  • Study site

    Sherbrooke, Quebec, J1H4J6

Other trials in Canada

About this study

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).

Read the 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).

Being tested
Trazodone Hydrochloride (HCl) Extended-Release Tablets, Placebo
Keywords
Unipolar
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trazodone Hydrochloride (HCl) Extended-Release TabletsDrug

    Also called Oleptro

  • PlaceboDrug

Study groups in NCT00775203
Study groupRoleWhat they receive
Trazodone Contramid Once A Day (OAD)ExperimentalNot described
Receives: Drug: Trazodone Hydrochloride (HCl) Extended-Release Tablets
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline to Week 8

Secondary outcomes (13)

  1. HAMD-17 Responders at Each Visit

    Number of patients who show a response (defined as at least a 50% reduction from baseline in HAMD-17 score) at each post-baseline visit.

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

  2. HAMD-17 Remitters at Each Visit

    Number of patients who are remitters (defined as patients who achieved a HAMD-17 total score ≤7) at each post-baseline visit.

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

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

    Change from baseline in the HAMD-17, item 1: Depressed Mood item, at each post-baseline visit. The Depressed Mood item is rated on a 5-point scale ranging from rating of 0=absent; to 4=very severe.

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

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

    The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10 item clinician-administered depression rating scale. The 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts) are rated on a scale ranging from 0 (low severity/difficulty) to 6 (high severity/difficulty) with anchors at 2-point intervals. The overall total score range is from 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).

    Measured: Baseline to Week 8

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

    The CGI-Severity (CGI-S) consists of one question for the investigator: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated on the following seven-point scale: 1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.

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

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

    The CGI-Improvement of Illness (CGI-I) consists of one question for the investigator: "Compared to his condition at the start of the study, how much has this patient changed?" which is rated on the following seven-point scale 1=very much improved; 2=much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6= much worse; 7=very much worse.

    Measured: Week 8

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

    The PGI-Improvement of Illness (PGI-I) consists of one question for the patient: "Since the start of the study, my overall status with regard to depression is?" which is rated on the following seven-point scale 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6= much worse; 7=very much worse.

    Measured: Week 8

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

    Patients were responders if the CGI-I rating was "Much Improved" or "Very Much Improved". The CGI-Improvement of Illness (CGI-I) consists of one question for the investigator: "Compared to his condition at the start of the study, how much has this patient changed?" which is rated on the following seven-point scale 1=very much improved; 2=much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6= much worse; 7=very much worse. Results are expressed in number of patients.

    Measured: Week 8

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

    Patients were responders if the PGI-I rating was "Much Improved" or "Very Much Improved". The PGI-Improvement of Illness (PGI-I) consists of one question for the patient: "Since the start of the study, my overall status with regard to depression is?" which is rated on the following seven-point scale 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6= much worse; 7=very much worse. Results are expressed in number of patients.

    Measured: Week 8

  10. Overall Quality of Sleep at Each Visit

    Overall Quality of Sleep was measured on a 4-point rating scale ranging from 1 = very poor to 4 = excellent in response to the question: "Since the last study visit, how would you rate the overall quality of your sleep?".

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

  11. Trouble Falling Asleep at Each Visit

    Trouble Falling Asleep was measured on a 4-point rating scale ranging from 1 = never to 4 = always in response to the question: "Since the last study visit, how often did you experience trouble falling asleep?".

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

  12. Awakening During the Night at Each Visit

    Awakening during the night was measured on a 4-point rating scale ranging from 1 = never to 4 = always in response to the question: "Since the last study visit did you awaken during the night?".

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

  13. Discontinuation Due to Lack of Efficacy

    Number of patients who discontinued due to lack of efficacy during the whole study period (8 weeks).

    Measured: Baseline to Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2008 (estimated)
  2. Study startJun 2007
  3. Primary completionNov 2007
  4. Study completionNov 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
412 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00775203
Sponsor's protocol ID
04ACL3-001
Status last verified
Apr 2012
First submitted
17 Oct 2008
Last updated
27 Apr 2012

Publications

  • 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.

    PubMed 19724732

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trazodone Hydrochloride (HCl) Extended-Release Tablets in people with Major Depressive Disorder, run by Labopharm Inc. at 36 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Apr 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hamilton Depression Scale (HAMD-17) Total Score From Baseline (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00775203, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2012.

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