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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.

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ClinicalTrials.gov Identifier: NCT00775203
Recruitment Status : Completed
First Posted : October 20, 2008
Results First Posted : April 7, 2010
Last Update Posted : April 27, 2012
Sponsor:
Information provided by:
Labopharm Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Trazodone Hydrochloride (HCl) Extended-Release Tablets
Drug: Placebo
Enrollment 412
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Trazodone Contramid OAD Placebo
Hide Arm/Group Description Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability. Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
Period Title: Overall Study
Started 206 206
Received Study Medication 202 204
Completed 144 163
Not Completed 62 43
Reason Not Completed
Adverse Event             25             6
Lack of Efficacy             8             9
Withdrawal by Subject             11             9
Lost to Follow-up             11             15
Administrative reason             2             0
Noncompliance             4             2
Protocol Violation             0             1
Entered other study             1             0
Physician Decision             0             1
Arm/Group Title Trazodone Contramid OAD Placebo Total
Hide Arm/Group Description Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability. Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD. Total of all reporting groups
Overall Number of Baseline Participants 202 204 406
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 202 participants 204 participants 406 participants
<=18 years
0
   0.0%
2
   1.0%
2
   0.5%
Between 18 and 65 years
193
  95.5%
186
  91.2%
379
  93.3%
>=65 years
9
   4.5%
16
   7.8%
25
   6.2%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 202 participants 204 participants 406 participants
43.8  (12.83) 44.0  (13.45) 43.9  (13.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 202 participants 204 participants 406 participants
Female
129
  63.9%
131
  64.2%
260
  64.0%
Male
73
  36.1%
73
  35.8%
146
  36.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 202 participants 204 participants 406 participants
United States 169 166 335
Canada 33 38 71
1.Primary Outcome
Title Change in Hamilton Depression Scale (HAMD-17) Total Score From Baseline
Hide Description 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).
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Week 8 Last Observation Carried Forward (LOCF): Trazodone = 202, placebo = 204.
Arm/Group Title Trazodone Contramid OAD Placebo
Hide Arm/Group Description:
Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
Overall Number of Participants Analyzed 202 204
Mean (Standard Deviation)
Unit of Measure: Points on HAMD-17 scale
Baseline 23.2  (4.16) 22.4  (4.43)
Week 8 or LOCF 11.8  (7.99) 13.2  (8.06)
Change from baseline -11.4  (8.20) -9.3  (7.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trazodone Contramid OAD, Placebo
Comments The primary null hypothesis for the HAMD-17 total score is that there is no difference between the Trazodone Contramid® OAD group and the placebo group at Week 8. A sample size of 133 in each group will have 90% power to detect a difference in the absolute mean Hamilton Rating Scale for Depression (HAMD-17) change from baseline of 3.0 units assuming that the common standard deviation is 7.5 using a two-group t-test with a 0.05 two-sided significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0119
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with treatment and study center as categorical factors and HAMD-17 baseline as covariate.
2.Secondary Outcome
Title HAMD-17 Responders at Each Visit
Hide Description 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.
Time Frame Weeks 1, 2, 3, 4, 6, 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).
Arm/Group Title Trazodone Contramid OAD Placebo
Hide Arm/Group Description:
Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
Overall Number of Participants Analyzed 202 204
Measure Type: Number
Unit of Measure: Participants
≥50% reduction in HAMD-17 at Week 1 (n=197, n=199) 25 19
≥50% reduction in HAMD-17 at Week 2 (n=201, n=203) 63 41
≥50% reduction in HAMD-17 at Week 3 (n=202, n=204) 89 53
≥50% reduction in HAMD-17 at Week 4 (n=202, n=204) 95 74
≥50% reduction in HAMD-17 at Week 6 (n=202, n=204) 100 81
≥50% reduction in HAMD-17 at Week 8 (n=202, n=204) 109 84
3.Secondary Outcome
Title HAMD-17 Remitters at Each Visit
Hide Description Number of patients who are remitters (defined as patients who achieved a HAMD-17 total score ≤7) at each post-baseline visit.
Time Frame Weeks 1, 2, 3, 4, 6, 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).
Arm/Group Title Trazodone Contramid OAD Placebo
Hide Arm/Group Description:
Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
Overall Number of Participants Analyzed 202 204
Measure Type: Number
Unit of Measure: Participants
Number of remitters at Week 1 (n=197, n=199) 10 9
Number of remitters at Week 2 (n=201, n=203) 29 24
Number of remitters at Week 3 (n=202, n=204) 51 32
Number of remitters at Week 4 (n=202, n=204) 61 43
Number of remitters at Week 6 (n=202, n=204) 66 47
Number of remitters at Week 8 (n=202, n=204) 72 65
4.Secondary Outcome
Title Change in HAMD-17 Depressed Mood Item (Item 1) Score From Baseline to Each Visit
Hide Description 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.
Time Frame Baseline to Weeks 1, 2, 3, 4, 6, 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).
Arm/Group Title Trazodone Contramid OAD Placebo
Hide Arm/Group Description:
Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
Overall Number of Participants Analyzed 202 204
Mean (Standard Deviation)
Unit of Measure: Points on the HAMD scale
Change in score at Week 1 (n=197, n=199) -0.7  (0.89) -0.5  (0.74)
Change in score at Week 2 (n=201, n=203) -1.1  (1.13) -0.8  (0.95)
Change in score at Week 3 (n=202, n=204) -1.4  (1.18) -1.0  (1.08)
Change in score at Week 4 (n=202, n=204) -1.5  (1.21) -1.2  (1.12)
Change in score at Week 6 (n=202, n=204) -1.5  (1.18) -1.3  (1.15)
Change in score at Week 8 (n=202, n=204) -1.6  (1.29) -1.3  (1.22)
5.Secondary Outcome
Title Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline
Hide Description 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).
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. MADRS Week 8 Observed Cases: Trazodone = 178, placebo = 182.
Arm/Group Title Trazodone Contramid OAD Placebo
Hide Arm/Group Description:
Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
Overall Number of Participants Analyzed 178 182
Mean (Standard Deviation)
Unit of Measure: Units on MADRS scale
Baseline (n=202, n=204) 32.6  (4.07) 31.9  (4.33)
Week 8 (n=178, n=182) 16.0  (11.24) 17.7  (11.62)
Change from baseline (n=178, n=182) -16.6  (11.27) -14.1  (11.27)
6.Secondary Outcome
Title Change From Baseline in Clinical Global Impression of Severity (CGI-S) to Each Visit
Hide Description 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.
Time Frame Baseline to Weeks 1, 2, 3, 4, 6, 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).
Arm/Group Title Trazodone Contramid OAD Placebo
Hide Arm/Group Description:
Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
Overall Number of Participants Analyzed 202 204
Mean (Standard Deviation)
Unit of Measure: Units on CGI-S scale
Change in CGI-S score at Week 1 (n=197, n=199) -0.6  (0.72) -0.5  (0.75)
Change in CGI-S score at Week 2 (n=201, n=203) -1.0  (1.02) -0.8  (0.98)
Change in CGI-S score at Week 3 (n=202, n=204) -1.4  (1.16) -1.1  (1.12)
Change in CGI-S score at Week 4 (n=202, n=204) -1.6  (1.22) -1.3  (1.17)
Change in CGI-S score at Week 6 (n=202, n=204) -1.7  (1.24) -1.4  (1.24)
Change in CGI-S score at Week 8 (n=202, n=204) -1.7  (1.36) -1.4  (1.37)
7.Secondary Outcome
Title Clinical Global Impression – Improvement of Illness (CGI-I) Score at Last Study Visit
Hide Description 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. CGI-I Week 8 Observed Cases: Trazodone = 178, placebo = 182.
Arm/Group Title Trazodone Contramid OAD Placebo
Hide Arm/Group Description:
Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
Overall Number of Participants Analyzed 178 182
Mean (Standard Deviation)
Unit of Measure: Units on the CGI-I scale
2.4  (1.23) 2.5  (1.32)
8.Secondary Outcome
Title Patient Global Impression – Improvement of Illness (PGI-I) Score at Last Study Visit
Hide Description 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. PGI-I Week 8 Observed Cases: Trazodone = 176, placebo = 183.
Arm/Group Title Trazodone Contramid OAD Placebo
Hide Arm/Group Description:
Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
Overall Number of Participants Analyzed 176 183
Mean (Standard Deviation)
Unit of Measure: Units on PGI-I scale
2.6  (1.19) 2.8  (1.35)
9.Secondary Outcome
Title Clinical Global Impression – Improvement of Illness (CGI-I) Responders at Last Study Visit
Hide Description 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. CGI-I Responders Week 8 Observed Cases: Trazodone = 180, placebo = 183.
Arm/Group Title Trazodone Contramid OAD Placebo
Hide Arm/Group Description:
Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
Overall Number of Participants Analyzed 180 183
Measure Type: Number
Unit of Measure: participants
96 89
10.Secondary Outcome
Title Patient Global Impression – Improvement of Illness (PGI-I) Responders at Last Study Visit
Hide Description 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. PGI-I Responders Week 8 Observed Cases: Trazodone = 176, placebo = 183.
Arm/Group Title Trazodone Contramid OAD Placebo
Hide Arm/Group Description:
Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
Overall Number of Participants Analyzed 176 183
Measure Type: Number
Unit of Measure: participants
90 80
11.Secondary Outcome
Title Overall Quality of Sleep at Each Visit
Hide Description 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?".
Time Frame Weeks 1, 2, 3, 4, 6, 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).
Arm/Group Title Trazodone Contramid OAD Placebo
Hide Arm/Group Description:
Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
Overall Number of Participants Analyzed 202 204
Mean (Standard Deviation)
Unit of Measure: Points on a scale
Score at Baseline (n=202, n=204) 1.6  (0.65) 1.6  (0.70)
Score at Week 1 (n=196, n=199) 0.7  (0.90) 0.4  (0.83)
Score at Week 2 (n=200, n=203) 0.8  (0.97) 0.7  (0.99)
Score at Week 3 (n=201, n=204) 0.9  (1.00) 0.7  (1.00)
Score at Week 4 (n=201, n=204) 1.0  (1.02) 0.7  (1.02)
Score at Week 6 (n=201, n=204) 1.0  (1.01) 0.9  (1.04)
Score at Week 8 (n=201, n=204) 1.0  (1.05) 0.8  (1.10)
12.Secondary Outcome
Title Trouble Falling Asleep at Each Visit
Hide Description 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?".
Time Frame Weeks 1, 2, 3, 4, 6, 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).
Arm/Group Title Trazodone Contramid OAD Placebo
Hide Arm/Group Description:
Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
Overall Number of Participants Analyzed 202 204
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Score at Baseline (n=202, n=204) 3.0  (0.86) 2.9  (0.91)
Score at Week 1 (n=196, n=199) 2.5  (1.02) 2.6  (0.98)
Score at Week 2 (n=200, n=203) 2.3  (0.93) 2.5  (0.96)
Score at Week 3 (n=201, n=204) 2.2  (0.90) 2.3  (0.99)
Score at Week 4 (n=201, n=204) 2.1  (0.89) 2.3  (0.95)
Score at Week 6 (n=201, n=204) 2.1  (0.89) 2.3  (0.95)
Score at Week 8 (n=201, n=204) 2.1  (0.85) 2.3  (0.95)
13.Secondary Outcome
Title Awakening During the Night at Each Visit
Hide Description 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?".
Time Frame Weeks 1, 2, 3, 4, 6, 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).
Arm/Group Title Trazodone Contramid OAD Placebo
Hide Arm/Group Description:
Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
Overall Number of Participants Analyzed 202 204
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Score at Baseline (n=202, n=204) 3.2  (0.78) 3.2  (0.78)
Score at Week 1 (n=196, n=199) 2.4  (0.96) 2.7  (0.85)
Score at Week 2 (n=200, n=203) 2.4  (0.94) 2.5  (0.92)
Score at Week 3 (n=201, n=204) 2.2  (0.91) 2.6  (0.90)
Score at Week 4 (n=201, n=204) 2.2  (0.89) 2.6  (0.93)
Score at Week 6 (n=201, n=204) 2.2  (0.94) 2.5  (0.95)
Score at Week 8 (n=201, n=204) 2.2  (0.89) 2.5  (0.95)
14.Secondary Outcome
Title Discontinuation Due to Lack of Efficacy
Hide Description Number of patients who discontinued due to lack of efficacy during the whole study period (8 weeks).
Time Frame Baseline to Week 8
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Hide Analysis Population Description
Safety population is defined as all randomized patients who received any study medication.
Arm/Group Title Trazodone Contramid OAD Placebo
Hide Arm/Group Description:
Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
Overall Number of Participants Analyzed 202 204
Measure Type: Number
Unit of Measure: participants
8 9
Time Frame 8 weeks (plus an additional 30 days for SAEs only)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Trazodone Contramid OAD Placebo
Hide Arm/Group Description Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability. Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
All-Cause Mortality
Trazodone Contramid OAD Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Trazodone Contramid OAD Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/202 (1.98%)      2/204 (0.98%)    
Gastrointestinal disorders     
Abdominal pain * 1  1/202 (0.50%)  1 0/204 (0.00%)  0
Duodenal ulcer * 1  1/202 (0.50%)  1 0/204 (0.00%)  0
Gastritis * 1  1/202 (0.50%)  1 0/204 (0.00%)  0
General disorders     
Death * 1  0/202 (0.00%)  0 1/204 (0.49%)  1
Infections and infestations     
Staphylococcal sepsis * 1  1/202 (0.50%)  1 0/204 (0.00%)  0
Viral pericarditis * 1  1/202 (0.50%)  1 0/204 (0.00%)  0
Psychiatric disorders     
Suicide attempt * 1  0/202 (0.00%)  0 1/204 (0.49%)  2
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism * 1  1/202 (0.50%)  1 0/204 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (8.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Trazodone Contramid OAD Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   168/202 (83.17%)      122/204 (59.80%)    
Eye disorders     
Vision blurred * 1  11/202 (5.45%)  12 0/204 (0.00%)  0
Gastrointestinal disorders     
Constipation * 1  16/202 (7.92%)  17 4/204 (1.96%)  7
Diarrhea * 1  19/202 (9.41%)  23 23/204 (11.27%)  29
Dry mouth * 1  51/202 (25.25%)  58 26/204 (12.75%)  26
Nausea * 1  42/202 (20.79%)  51 26/204 (12.75%)  30
General disorders     
Fatigue * 1  30/202 (14.85%)  34 17/204 (8.33%)  17
Musculoskeletal and connective tissue disorders     
Back pain * 1  11/202 (5.45%)  15 7/204 (3.43%)  8
Nervous system disorders     
Dizziness * 1  50/202 (24.75%)  57 25/204 (12.25%)  25
Headache * 1  67/202 (33.17%)  89 55/204 (26.96%)  98
Sedation * 1  34/202 (16.83%)  39 7/204 (3.43%)  10
Somnolence * 1  63/202 (31.19%)  80 32/204 (15.69%)  36
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (8.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Prior to submitting results communications, the investigator shall allow Labopharm at least 60 days to review the proposed communication. If the proposed publication/disclosure risks Labopharm’s ability to patent any invention related to the study, the publication or disclosure will be modified/delayed to allow Labopharm to seek patent protection. This statement does not give Labopharm any editorial rights other than to restrict the disclosure of Labopharm’s confidential information.
Results Point of Contact
Name/Title: Director of Regulatory Affairs
Organization: Labopharm Inc.
Phone: 1 450 686 1017
Responsible Party: Vice-President Regulatory Affairs, Labopharm Inc.
ClinicalTrials.gov Identifier: NCT00775203     History of Changes
Other Study ID Numbers: 04ACL3-001
First Submitted: October 17, 2008
First Posted: October 20, 2008
Results First Submitted: February 25, 2010
Results First Posted: April 7, 2010
Last Update Posted: April 27, 2012