Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 11 of 489 for:    ESCITALOPRAM AND Antagonists

To Assess the Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients With Major Depressive Disorder (MDD) (ACES 257)

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.
 
ClinicalTrials.gov Identifier: NCT01123707
Recruitment Status : Terminated
First Posted : May 14, 2010
Last Update Posted : August 31, 2012
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Tracking Information
First Submitted Date  ICMJE May 12, 2010
First Posted Date  ICMJE May 14, 2010
Last Update Posted Date August 31, 2012
Study Start Date  ICMJE November 2010
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2010)
Safety - based on the frequency and severity of AEs & SAEs [ Time Frame: 1 year ]
The primary evaluation of safety will be through frequency and severity of adverse events (AEs), including serious AEs (SAEs), and discontinuations due to AEs. In addition to AEs, safety variables examined in this study will include physical exams, vital signs, body weight, body mass index, clinical laboratory tests, electrocardiograms, the Abnormal Involuntary Movement Scale (AIMS), the Simpson Angus Scale (SAS), the Barnes Akathisia Rating Scale (BARS), the Columbia-Suicide Severity Rating Scale (C-SSRS), and the Massachusetts General Hospital Sexual Functioning Inventory (MGH SFI).
Original Primary Outcome Measures  ICMJE
 (submitted: May 13, 2010)
Safety - based on the frequency and severity of AEs & SAEs [ Time Frame: 1 year ]
The primary evaluation of safety will be through frequency and severity of adverse events (AEs), including serious AEs (SAEs), and discontinuations due to AEs. In addition to AEs, safety variables examined in this study will include physical examinations, vital signs, body weight, body mass index, clinical laboratory tests,electrocardiograms, the Abnormal Involuntary Movement Scale (AIMS), the Simpson Angus Scale (SAS), the Barnes Akathisia Rating Scale (BARS), the Columbia-Suicide Severity Rating Scale (C-SSRS), and the Massachusetts General Hospital Sexual Functioning Questionnaire (MSFQ).
Change History Complete list of historical versions of study NCT01123707 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2010)
Efficacy [ Time Frame: 1 year ]
Evaluation of efficacy will include the Clinical Global Impressions Severity of Illness Scale (CGI-S) and the Patient Global Impressions of Severity Scale (PGI-S). Outcome: The Sheehan Disability Scale (SDS), the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q - Short Form), and the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ). Responses to the Resource Utilization Form will be summarized appropriately to explore the impact of treatment on health care resources.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Assess the Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients With Major Depressive Disorder (MDD)
Official Title  ICMJE A Multicenter, 52-week, Open-label Study to Assess the Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients With Major Depressive Disorder
Brief Summary This will be a multicenter, 52-week, open-label study designed to assess the safety and tolerability of an oral aripiprazole/escitalopram combination therapy in outpatients with major depressive disorder (MDD). Enrollment into the study will be from eligible subjects who have completed participation in Protocol 31-08-255, 31-08-256, or 31-08-263 ("rollover" subjects).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder (MDD)
Intervention  ICMJE Drug: Aripiprazole/Escitalopram combination therapy
Aripiprazole/Escitalopram combination therapy: 3 mg/10 mg, 3 mg/20 mg, 6 mg/10 mg, 6 mg/20 mg, 12 mg/10 mg or 12 mg/20 mg
Study Arms  ICMJE Experimental: Aripiprazole/Escitalopram combination therapy
Intervention: Drug: Aripiprazole/Escitalopram combination therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 13, 2012)
170
Original Estimated Enrollment  ICMJE
 (submitted: May 13, 2010)
1500
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who participated in Protocol 31-08-255, 31-08-256, or 31-08-263.

Exclusion Criteria:

  • Subjects with a current need for involuntary commitment or who have been hospitalized ≤ 28 days of the Baseline Visit for the current major depressive episode.
  • Subjects with a diagnosis of delirium, dementia, amnestic or other cognitive disorder, schizophrenia, schizoaffective disorder, or other psychotic disorder, Bipolar I or II disorder, Eating disorder (including anorexia nervosa or bulimia), obsessive compulsive disorder, panic disorder, or posttraumatic stress disorder.
  • Subjects with a diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.
  • Subjects experiencing hallucinations, delusions, or any psychotic symptomatology in the current depressive episode.
  • Subjects who have met DSM-IV-TR criteria for substance abuse in the past 6 months (prior to the Baseline Visit) and/or dependence up to and including the past 12 months (prior to the Baseline Visit), including alcohol and benzodiazepines, but excluding caffeine and nicotine. Subjects with two positive drug results for cocaine should be excluded from the study.
  • Subjects with hypothyroidism or hyperthyroidism.
  • Subjects with a significant risk of committing suicide based on history, investigator's judgment, and/or evaluation based on the C-SSRS
  • Subjects who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders.
  • Subjects with insulin-dependent diabetes mellitus (IDDM).
  • Subjects with epilepsy or significant history of seizure disorders, except for a single childhood febrile seizure, post-traumatic, etc.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 66 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Estonia,   Germany,   India,   Italy,   Korea, Republic of,   Mexico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01123707
Other Study ID Numbers  ICMJE 31-08-257
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Sponsor  ICMJE Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Otsuka Pharmaceutical Development & Commercialization, Inc.
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP