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
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder (MDD)||Drug: Aripiprazole/Escitalopram combination therapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||170 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|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
- 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).
- 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.
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