A Randomized, Double-blind, Two-arm Study Comparing the E... | NCT00775203

Label	Type	Description	Intervention Names
Trazodone Contramid Once A Day (OAD)	Experimental		Drug: Trazodone Hydrochloride (HCl) Extended-Release Tablets
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Trazodone Hydrochloride (HCl) Extended-Release Tablets	Drug		Trazodone Contramid Once A Day (OAD)	Oleptro

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.	Weeks 1, 2, 3, 4, 6, 8
HAMD-17 Remitters at Each Visit

Eligibility Module

Eligibility 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-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.

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.

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama	35216	United States

PubMed Identifier	Type	Citation	Retractions
19724732	Result	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.

Label	URL
Approved labelling	View source

ID	Title	Description
FG000	Trazodone Contramid OAD	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.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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).

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.

Posted

Mean

Standard Deviation

Points on HAMD-17 scale

Baseline to Week 8

ID	Title	Description
OG000	Trazodone Contramid OAD	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.
OG001	Placebo	Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.

Units	Counts
Participants	OG000202 OG001204

Title

Denominators

Categories

Baseline

Title	Measurements
	OG00023.2± 4.16 OG00122.4± 4.43

Week 8 or LOCF

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	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.	ANCOVA	ANCOVA with treatment and study center as categorical factors and HAMD-17 baseline as covariate.	0.0119													No	Superiority or Other

Secondary

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.

Posted

Number

Participants

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

ID	Title	Description
OG000	Trazodone Contramid OAD	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.
OG001	Placebo	Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.

Units	Counts

Secondary

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.

Posted

Number

Participants

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

ID	Title	Description
OG000	Trazodone Contramid OAD	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.
OG001	Placebo	Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.

Units	Counts

Secondary

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.

Posted

Mean

Standard Deviation

Points on the HAMD scale

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

ID	Title	Description
OG000	Trazodone Contramid OAD	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.
OG001	Placebo	Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.

Secondary

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).

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.

Posted

Mean

Standard Deviation

Units on MADRS scale

Baseline to Week 8

ID	Title	Description
OG000	Trazodone Contramid OAD	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.
OG001	Placebo

Secondary

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.

Posted

Mean

Standard Deviation

Units on CGI-S scale

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

ID	Title	Description
OG000	Trazodone Contramid OAD	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.
OG001	Placebo	Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.

Secondary

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.

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.

Posted

Mean

Standard Deviation

Units on the CGI-I scale

Week 8

ID	Title	Description
OG000	Trazodone Contramid OAD	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.
OG001	Placebo	Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.

Secondary

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.

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.

Posted

Mean

Standard Deviation

Units on PGI-I scale

Week 8

ID	Title	Description
OG000	Trazodone Contramid OAD	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.
OG001	Placebo	Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.

Secondary

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.

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.

Posted

Number

participants

Week 8

ID	Title	Description
OG000	Trazodone Contramid OAD	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.
OG001	Placebo	Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.

Secondary

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.

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.

Posted

Number

participants

Week 8

ID	Title	Description
OG000	Trazodone Contramid OAD	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.
OG001	Placebo	Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.

Secondary

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?".

Posted

Mean

Standard Deviation

Points on a scale

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

ID	Title	Description
OG000	Trazodone Contramid OAD	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.
OG001	Placebo	Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.

Secondary

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?".

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).

Posted

Mean

Standard Deviation

Units on a scale

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

ID	Title	Description
OG000	Trazodone Contramid OAD	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.
OG001	Placebo	Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.

Secondary

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?".

Posted

Mean

Standard Deviation

Units on a scale

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

ID	Title	Description
OG000	Trazodone Contramid OAD	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.
OG001	Placebo	Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.

Secondary

Discontinuation Due to Lack of Efficacy

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

Safety population is defined as all randomized patients who received any study medication.

Posted

Number

participants

Baseline to Week 8

ID	Title	Description
OG000	Trazodone Contramid OAD	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.
OG001	Placebo	Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.

Units	Counts
Participants

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vision blurred	Eye disorders	MedDRA (8.0)	Non-systematic Assessment	EG00012 events11 affected202 at risk EG0010 events0 affected204 at risk
Constipation	Gastrointestinal disorders	MedDRA (8.0)	Non-systematic Assessment	EG00017 events16 affected202 at risk EG0017 events4 affected204 at risk
Diarrhea	Gastrointestinal disorders	MedDRA (8.0)	Non-systematic Assessment	EG00023 events19 affected202 at risk EG00129 events23 affected204 at risk
Dry mouth	Gastrointestinal disorders	MedDRA (8.0)	Non-systematic Assessment	EG00058 events51 affected202 at risk EG00126 events26 affected204 at risk
Nausea	Gastrointestinal disorders	MedDRA (8.0)	Non-systematic Assessment	EG00051 events42 affected202 at risk EG00130 events26 affected204 at risk
Fatigue	General disorders	MedDRA (8.0)	Non-systematic Assessment	EG00034 events30 affected202 at risk EG00117 events17 affected204 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (8.0)	Non-systematic Assessment	EG00015 events11 affected202 at risk EG0018 events7 affected204 at risk
Dizziness	Nervous system disorders	MedDRA (8.0)	Non-systematic Assessment	EG00057 events50 affected202 at risk EG00125 events25 affected204 at risk
Headache	Nervous system disorders	MedDRA (8.0)	Non-systematic Assessment	EG00089 events67 affected202 at risk EG00198 events55 affected204 at risk
Sedation	Nervous system disorders	MedDRA (8.0)	Non-systematic Assessment	EG00039 events34 affected202 at risk EG00110 events7 affected204 at risk
Somnolence	Nervous system disorders	MedDRA (8.0)	Non-systematic Assessment	EG00080 events63 affected202 at risk EG00136 events32 affected204 at risk

ID	Term
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011728	Pyridones
D011725	Pyridines

ID	Title	Description
BG000	Trazodone Contramid OAD	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.
BG001	Placebo	Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Trazodone Contramid OAD	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.			4	202	168	202
EG001	Placebo	Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.			2	204	122	204

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA (8.0)	Non-systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected204 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA (8.0)	Non-systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected204 at risk
Gastritis	Gastrointestinal disorders	MedDRA (8.0)	Non-systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected204 at risk
Death	General disorders	MedDRA (8.0)	Non-systematic Assessment	EG0000 events0 affected202 at risk EG0011 events1 affected204 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA (8.0)	Non-systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected204 at risk
Viral pericarditis	Infections and infestations	MedDRA (8.0)	Non-systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected204 at risk
Suicide attempt	Psychiatric disorders	MedDRA (8.0)	Non-systematic Assessment	EG0000 events0 affected202 at risk EG0012 events1 affected204 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (8.0)	Non-systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected204 at risk

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders