Study Of 323U66 SR In Major Depressive Disorder

Study Overview
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Brief Summary
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This study was designed to evaluate the efficacy and safety in major depressive disorder patients.

Official Title
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An Open-Label, Multi-Center, Phase II Study Evaluating the Safety and Efficacy of 323U66 SR in Patients With Depression

Conditions
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Depressive Disorder

Intervention / Treatment
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* Drug: bupropion hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Met DSM-IV-TR criteria for major depressive disorder for their current episode for at least 8 weeks prior to screening visit. Must give a written informed consent. But if the patient is under 20, both the patient himself/herself and his/her proxy consenter must give written informed consent. Must have rating scores as outlined. Exclusion criteria: Current or past history of seizure disorder or brain injury. Current or past history of anorexia or bulimia nervosa. History of manic episode. Past or current DSM- IV-TR diagnosis of schizophrenia or other psychotic disorder. Diagnosis of substance abuse (alcohol or drug) by the DSM-IV-TR criteria. Pregnant, possibly pregnant or lactating. Must not be suicidal. Blood pressure of SBP>160mmHg, DBP>100mmHg. History or complication of cancer or malignant tumour.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bupropion hydrochloride|Study drug|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8 in Observed Cases | The MADRS is a semi-structured interview rating scale for depression that assesses 10 symptoms. The scale is composed of 10 questions (1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts) with a fixed 7 point scale (0, no depression; 60, severely depressed). Total score ranges from 0-60. A higher score indicates more depressive symptoms. MADRS Response was defined as a reduction in MADRS score from Baseline. Change from Baseline in the total score was calculated as the value at Week 8 minus the value at Baseline. Baseline was defined as value at Week 0. | Baseline (Week 0) and Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the MADRS Total Score at Week 52 in Observed Cases | The MADRS is a semi-structured interview rating scale for depression that assesses 10 symptoms. The scale is composed of 10 questions (1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts) with a fixed 7 point scale (0, no depression; 60, severely depressed). Total score ranges from 0-60. A higher score indicates more depressive symptoms. MADRS Response was defined as a reduction in MADRS score from Baseline. Change from Baseline in the total score was calculated as the value at Week 52 minus the value at Baseline. Baseline was defined as value at Week 0. | Baseline (Week 0) and Week 52 | 
| Change From Baseline in the Hamilton Depression Rating Scale (HAM-D; 17 Items) Total Score at Weeks 8 and 52 in Observed Cases | Each item was rated on either a 3-point scale (0 to 2; 8 questions) or a 5-point scale (0 to 4; 9 questions), with higher scores indicating greater symptom severity. The total score was calculated by summing the individual response scores. Total score ranged from 0 to 52. The following symptoms were rated on a 5-point scale (0-4): depressed mood, low self-esteem (guilt), suicidal thoughts, work and interests, psychomotor retardation, psychomotor agitation, anxiety (psychic), anxiety (somatic), and hypochondriasis (somatization). The following symptoms were rated on a 3-point scale (0-2): insomnia (initial), insomnia (middle), insomnia (late), gastrointestinal symptoms (appetite), somatic symptoms (general), sexual disturbances, insight, and weight loss. Change from Baseline in the total score was calculated as the score at Week 8 and 52 minus the score at Baseline. Baseline was defined as value at Week 0. | Baseline (Week 0) and Week 8, 52 | 
| Percentage of Participants Who Were Clinical Global Impression Global Improvement (CGI-I) Responders at Weeks 8 and 52 in Observed Cases | The CGI-I scale was used to rate improvement in the participant's condition (benefits) since Baseline using the following 7-point scale: 1: very much improved, 2: much improved, 3: minimally improved, 4: not changed, 5: minimally worse, 6: much worse and 7: very much worse. A responder was defined as very much improved or much improved. | Week 8, 52 | 
| Change From Baseline in CGI Severity of Illness (CGI-SI) at Weeks 8 and 52 in Observed Cases | CGI-SI was assessed on an 8-grade scale: 0, not assessed; 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill and 7, among the most extremely ill. Higher score indicated severely ill. CGI-SI was assessed by the investigator. The change from Baseline in CGI-SI score was calculated as the score at Weeks 8 and 52 minus the score at Baseline. Baseline was defined as value at Week 0. | Baseline (Week 0) and Week 8, 52 | 
| Change From Baseline in the Sheehan Disability Scale (SDISS) Total Score at Weeks 8 and 52 in Observed Cases | SDISS is a composite of 3 self-rated items designed to measure the extent to which 3 major sectors in the participant's life are impaired by panic, anxiety, phobic, or depressive symptoms. The participant rates the extent to which his or her (1) work, (2) social life or leisure activities, and (3) home life or family responsibilities were impaired by his or her symptoms on a 10-point visual analog scale. To get a total score, 3 individual scores were added and the total score ranged from 0 = unimpaired to 30 = highly impaired. Higher scores indicate worsening. The change from Baseline in SDISS total score was calculated as the score at Weeks 8 and 52 minus the score at Baseline. Baseline was defined as value at Week 0. | Baseline (Week 0) and Week 8, 52 | 
| Change From Baseline in the Motivation Energy Inventory Short Form (MEI-SF) Total Score at Weeks 8 and 52 in Observed Cases | The MEI-SF (18 questions) was used to measure the reductions in mental energy, physical energy and social motivation. Minimal clinically important differences were estimated as 0.5 standard deviations or 7.5 points. All items use either a 7-level (0 to 6) or 5-level (0 to 4) response scale; items with a 5-level response scale were rescaled to 7-levels and items were reverse-scored as necessary such that higher scores represent higher health-related quality of life (HRQoL) total score ranges from 0 to 108 points. Recall period was past week prior to administration. The change from Baseline in MEI-SF total score was calculated as the score at Weeks 8 and 52 minus the score at Baseline. Baseline was defined as value at Week 0. | Baseline (Week 0) and Week 8, 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MDD