Clinical trial NCT01123707: To Assess the Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Major Depressive Disorder (MDD)
Keywords: Major Depressive Disorder
MDD
Depression
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-14
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group composed of eligible rollover participants who completed one of the previous studies: 31-08-255 \[NCT01111539\], 31-08-256 \[NCT01111552\], or 31-08-263 \[NCT01111565\]
Primary purpose: TREATMENT

Brief summary: This is 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 participants who have completed participation in Protocol 31-08-255 \[NCT01111539\], 31-08-256 \[NCT01111552\], or 31-08-263 \[NCT01111565\] ("rollover" participants).


Eligibility criteria: Inclusion Criteria:

* Participants who participated in Protocol 31-08-255, 31-08-256, or 31-08-263.

Exclusion Criteria:

* Participants with a current need for involuntary commitment or who have been hospitalized ≤ 28 days of the Baseline Visit for the current major depressive episode.
* Participants 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.
* Participants with a diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.
* Participants experiencing hallucinations, delusions, or any psychotic symptomatology in the current depressive episode.
* Participants who have met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (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. Participants with two positive drug results for cocaine should be excluded from the study.
* Participants with hypothyroidism or hyperthyroidism.
* Participants with a significant risk of committing suicide based on history, investigator's judgment, and/or evaluation based on the Columbia-Suicide Severity Rating Scale (C-SSRS).
* Participants who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders.
* Participants with insulin-dependent diabetes mellitus (IDDM).
* Participants with epilepsy or significant history of seizure disorders, except for a single childhood febrile seizure, post-traumatic, etc.

Primary outcomes:
measure: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs), Severe (Grade 3 or Higher) TEAEs, and Discontinuations From the Trial Due to TEAEs
timeFrame: From first dose up to 30 days post last dose (Up to approximately 40 weeks)
Secondary outcomes:
measure: Mean Change From Baseline in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score
timeFrame: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)
measure: Mean Change From Baseline in Patient Global Impression - Severity of Depression Scale (PGI-S) Score
timeFrame: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)
measure: Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities
timeFrame: Up to 40 weeks
measure: Mean Change From Baseline in Body Weight
timeFrame: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)
measure: Mean Change From Baseline in Body Mass Index (BMI)
timeFrame: Baseline, Week 26 and End of the study visit (Week 43 or before)
measure: Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
timeFrame: Up to 40 weeks
measure: Mean Change From Baseline in Laboratory Test Results: Prolactin
timeFrame: Baseline, Weeks 8, 26, and End of the study visit (Week 43 or before)
measure: Mean Change From Baseline in Laboratory Test Results: Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 8, and End of the study visit (Week 43 or before)
measure: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
timeFrame: Up to 40 weeks
measure: Number of Participants With Potentially Clinically Significant Physical Examination Findings
timeFrame: Up to 40 weeks
measure: Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score
timeFrame: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)
measure: Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score
timeFrame: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)
measure: Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Clinical Assessment of Akathisia (Item 4) Score
timeFrame: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)
measure: Percentage of Participants With Suicidal Ideation in Each Item as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline; Weeks 1, 2, 4, 6, 8, 14 and Last Visit (Week 43 or before)
measure: Mean Change From Baseline in Each Item as Measured by Massachusetts General Hospital Sexual Functioning Inventory (MGH SFI) Subscale Score
timeFrame: Baseline, Weeks 8, 26 and End of the study visit (Week 43 or before)
measure: Mean Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) Overall General Subscore
timeFrame: Baseline, Week 8, 26 and End of the study visit (Week 43 or before)
measure: Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Total Score
timeFrame: Baseline, Weeks 8, 26 and End of the study visit (Week 43 or before)
measure: Mean Change From Baseline in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) Total Score
timeFrame: Baseline, Weeks 8, 26 and End of the study visit (Week 43 or before)
Other outcomes:
Locations:
Study officials:
References: