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

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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.

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).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder (MDD) Drug: Aripiprazole/Escitalopram combination therapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : December 2011

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Arm Intervention/treatment
Experimental: Aripiprazole/Escitalopram combination therapy 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




Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT01123707


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Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.

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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01123707     History of Changes
Other Study ID Numbers: 31-08-257
First Posted: May 14, 2010    Key Record Dates
Last Update Posted: August 31, 2012
Last Verified: August 2012
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Major Depressive Disorder
MDD
Depression
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Dexetimide
Aripiprazole
Citalopram
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Antipsychotic Agents