A global study to see how safe, effective and well tolerated a capsule containing Aripiprazole and Escitalopram is in people with depression.
- Conditions
- Major Depressive Disorder (MDD)MedDRA version: 14.0Level: LLTClassification code 10025454Term: Major depressive disorder, recurrent episodeSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]
- Registration Number
- EUCTR2010-018860-17-EE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1500
1. Subjects who are able to provide written informed consent and/or consent obtained from a legally acceptable representative (as required by IRB/IEC), prior to the initiation of any protocol-required procedures.
2. Ability, in the opinion of the principal investigator, to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet/capsule ingestion, and discontinuation of prohibited concomitant medication; to read and understand the written word in order to complete subject-reported outcomes measures; and to be reliably rated on assessment scales.
3. Male or female outpatients 18 to 66 years of age, inclusive, at the time of informed consent.
4. Subjects who have participated in Protocol 31-08-255, 31-08-256 or 31-08-263 and who, in the opinion of the investigator, could potentially benefit form the administration of oral aripiprazole/escitalopram combination therapy. Eligible subjects include those who:
a) completed participation in the Randomization Phase (Phase C, Week 14 Visit) or
b) met criteria for a response at the end of the Prospective treatment Phase (Phase B, Week 8 Visit) and at the end of Phase B+ (Week 14 Visit) did not meet criteria for remission (defined as a MADRS Total Score =<10).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1500
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Sex and Reproductive Status
1. Sexually active males or females of childbearing potential who are not practicing two different methods of birth control during the study and for 90 or 30 days respectively after the last dose of study medication or who will not remain abstinent during the study and for 90 or 30 days respectively after the last dose. (*)
2. Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug.
Target Disease
3. 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.
4. Subjects with a current Axis I (DSM-IV-TR) diagnosis of any of the disorders listed in the protocol (*)
5. Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.
6. Subjects experiencing hallucinations, delusions or any psychotic symptomatology in the current depressive episode.
Medical History and Concurrent Diseases
7. Subjects with a significant risk of committing suicide based on history, investigator’s judgement, and/or evaluation based on the C-SSRS.
8. 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 Baseline Visit), including alcohol and benzodiazepines, but excluding caffeine and nicotine. (*)
9. Subjects with hypothyroidism or hyperthyroidism (unless condition has been stabilized with medications for at least 90 days prior to the Baseline Visit). (*)
10. Subjects who currently have clinically significant neurological, hepatic, renal, metabolic, haematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders. (*)
11. Subjects with insulin-dependant diabetes mellitus (IDDM) are excluded. Subjects with non-IDDM may be eligible for the study if their condition is stable as determined by satisfying ALL of the criteria in protocol. (*)
12. Subjects with epilepsy or significant history of seizure disorders, except a single childhood febrile seizure, posttraumatic, etc. An alcohol withdrawal seizure up to and including 24 months of the Baseline Visit is exclusionary.
Physical and Laboratory Results
13. Subjects with two positive drug screens for cocaine or other drugs of abuse (excluding stimulants and other prescribed medications and marijuana) (*)
14. The following laboratory test are exclusionary: Platelets =< 75,000/mm3; Hemoglobin =< 9 g/dL; Neutrophils, absolute =< 1000/mm3; AST > 3x upper limit of normal as defined by the central laboratory; ALT > 3x upper limit of normal as defined by the central laboratory; Creatinine >= 2 mg/dL; (*)
Prohibited Therapies or Medications
15. Subjects who would be likely to require prohibited prior or concomitant therapy during the trial (*)
16. Anticipated need for diphenylhydramine or hydroxyzine during the study and other antihistamines for the treatment of agitation, anxiety or insomnia.
Allergies and Adverse Drug Reactions
17. History of allergy or hypersensitivity to aripiprazole or escitalopram.
18. Subjects with a history of neuroleptic malignant syndrome or serotonin syndrome.
Other
19. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg. infectious disease) illness must not b
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the 52-week safety and tolerability of an oral aripiprazole/escitalopram combination therapy in the treatment of patients with MDD.;Secondary Objective: N/A;Primary end point(s): The primary outcome variable of safety will be the frequency and severity of AEs, including serious AEs (SAEs) and discontinuations from the study due to AEs.;Timepoint(s) of evaluation of this end point: Refer to E.5.1
- Secondary Outcome Measures
Name Time Method