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Study Of 323U66 SR In Major Depressive Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00135512
First Posted: August 26, 2005
Last Update Posted: June 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
This study was designed to evaluate the efficacy and safety in major depressive disorder patients.

Condition Intervention Phase
Depressive Disorder Drug: bupropion hydrochloride Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multi-Cetre, Phase II Study Evaluating the Safety and Efficacy of 323U66 SR in Patients With Depression

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from Baseline in the Montgomery-Asberg depression rating scale (MADRS) total score at Week 8 in observed cases [ Time Frame: Baseline (Week 0) and Week 8 ]
    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.


Secondary Outcome Measures:
  • Change from Baseline in the MADRS total score at Week 52 in observed cases [ Time Frame: Baseline (Week 0) and Week 52 ]
    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.

  • Change from Baseline in the Hamilton depression rating scale (HAM-D; 17 items) total score at Weeks 8 and 52 in observed cases [ Time Frame: Baseline (Week 0) and Week 8, 52 ]
    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.

  • Percentage of participants who were Clinical Global Impression global improvement (CGI-I) responders at Weeks 8 and 52 in observed cases [ Time Frame: Week 8, 52 ]
    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".

  • Change from Baseline in CGI severity of illness (CGI-SI) at Weeks 8 and 52 in observed cases [ Time Frame: Baseline (Week 0) and Week 8, 52 ]
    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.

  • Change from Baseline in the Sheehan Disability Scale (SDISS) total score at Weeks 8 and 52 in observed cases [ Time Frame: Baseline (Week 0) and Week 8, 52 ]
    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.

  • Change from Baseline in the Motivation Energy Inventory Short Form (MEI-SF) total score at Weeks 8 and 52 in observed cases [ Time Frame: Baseline (Week 0) and Week 8, 52 ]
    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.


Enrollment: 100
Study Start Date: December 1, 2004
Study Completion Date: May 28, 2007
Primary Completion Date: May 1, 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: bupropion hydrochloride
    Study drug
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00135512


Locations
Japan
GSK Investigational Site
Fukuoka, Japan, 814-0180
GSK Investigational Site
Hyogo, Japan, 651-1145
GSK Investigational Site
Kanagawa, Japan, 228-0828
GSK Investigational Site
Kumamoto, Japan, 861-8002
GSK Investigational Site
Saitama, Japan, 332-0012
GSK Investigational Site
Tokyo, Japan, 160-0023
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00135512     History of Changes
Other Study ID Numbers: AK1102364
First Submitted: August 24, 2005
First Posted: August 26, 2005
Last Update Posted: June 22, 2017
Last Verified: June 2017

Keywords provided by GlaxoSmithKline:
MDD

Additional relevant MeSH terms:
Depressive Disorder
Depression
Mood Disorders
Mental Disorders
Behavioral Symptoms
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors