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: 13.1Level: LLTClassification code 10025454Term: Major depressive disorder, recurrent episodeSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2010-018796-21-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 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 and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.
4. Subjects with current diagnosis of a major depressive episode, as defined by DSM-IV-TR criteria and confirmed by M.I.N.I. The current depressive episode must be >= 8 weeks in duration and fulfil the following criteria:
Subjects who have a history for the current depressive episode of an inadequate response to at least one and no more than three adequate trials of an approved antidepressant treatment other than escitalopram. An inadequate response is defined as <50% reduction in depressive symptom severity, as assessed by the subject’s self-report on the ATRQ (*) and evaluated by the investigator as part of the subject’s medical and psychiatric history. An adequate trial is defined as an antidepressant treatment for at least 6 weeks (or at least 3 weeks for combination treatments) in duration at an approve dose as specified in the ATRQ. If the subject has received treatment for the current depressive episode with an approved antidepressant treatment that is not listed on the ATRQ, please contact the medical monitor to determine eligibility for inclusion into the trial. If the subject showed >= 50% improvement on any antidepressant trial in the current episode, then the subject must have had an inadequate response to a subsequent adequate antidepressant trial (as defined above by the ATRQ) of another antidepressant treatment prior to the Screen Visit. For the most recent antidepressant trial, the subject must not report >= 50% improvement (as defined above by the ATRQ).
5. Subjects with a HAM-D17 Total Score >= 18 at the Baseline Visit for the Prospective Treatment Phase.
6. Subjects willing to discontinue all prohibited psychotropic medication starting from the time of signing the informed consent and during the study period (*).
Inclusion Criteria Required for Entry into Phase C (Double-blind Randomization Phase)
7. HAM-D17 Total Score >= 14 at the Week 8 visit
8. HAM-D17 Total Score at the Week 8 Visit is less that a 50% reduction from the Baseline Visit
9. CGI-I score >= 3 at the Week 6 and Week 8 visits.
* please see protocol for further information
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. Lack of prior treatment with an antidepressant during the current depressive episode.
4. Subjects who report treatment with adjunctive monotherapy antipsychotic treatment during the current depressive episode.
5. Subjects who have received ECT in the last 10 years.
6. Subjects who have had a vagus nerve stimulation device implanted for management of treatment-resistant depression, or have received any of the additional somatic treatments listed in protocol* up to and including the past 10 years and/or for the current depressive episode
7. Subjects with a current need for involuntary commitment or who have been hospitalized <= 28 days of the Screen Visit for the current major depressive episode.
8. Subjects with a current Axis I (DSM-IV-TR) diagnosis of any of the disorders listed in the protocol (*)
9. Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.
10. Subjects experiencing hallucinations, delusions or any psychotic symptomatology in the current depressive episode.
11. Subjects receiving new onset psychotherapy (individual, group, marriage, or family therapy) up to and including 42 days of baseline or at anytime during participation in the trial.
Medical History and Concurrent Diseases
12. Subjects with a significant risk of committing suicide based on history, investigator’s judgement, and/or evaluation based on the C-SSRS.
13. Subjects who have met DSM-IV-TR criteria for substance abuse in the past 6 months (prior to the Screen Visit) and/or dependence up to and including the past 12 months (prior to Screen Visit), including alcohol and benzodiazepines, but excluding caffeine and nicotine. (*)
14. Subjects with hypothyroidism or hyperthyroidism (unless condition has been stabilized with medications for at least 90 days prior to the Screen Visit). (*)
15. Subjects who currently have clinically significant neurological, hepatic, renal, metabolic, haematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders. (*)
16. 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 listed in protocol. (*)
17. Subjects with epilepsy or significant history of seizure disorders, except for a single childhood febrile seizure, posttraumatic, etc. An alcohol withdrawal seizure up to and including 24 months of the Screen Visit is exclusionary.
Physical and Laboratory Results
18. Subjects with two positive drug screens for cocaine or other drugs of abuse (excluding stimulants and other prescribed medications and marijuana) (*)
19. The following laboratory test, vital signs and ECG results 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 u
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method