Health Condition 1: F339- Major depressive disorder, recurrent, unspecified
Conditions
Interventions
Intervention1: Vortioxetine (Lu AA21004): Vortioxetine (Lu AA21004)
5, 10 and 20 mg/day, tablets, orally.
Patients who are eligible will receive 10 mg vortioxetine once daily. At the scheduled visits,
Sponsors
H Lundbeck AS
Lundbeck India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient is capable of communicating with the site personnel. 2. The patient is able to read and understand the Informed Consent Form. 3. The patient has signed the Informed Consent Form. No study-related procedures may be performed before the patient has signed the form. 4. The patient is an outpatient, willing and able to attend study appointments within the specified time windows. 5. The patient has major depressive episode, is diagnosed with MDD according to DSM-5�® and would benefit from pharmacological treatment with vortioxetine. The current MDE should be confirmed using the Mini International Neuropsychiatric Interview (MINI). 6. The patient has a CGI-S score â�¥4 at the Screening and Baseline Visits. 7. The patient is a man or woman, aged â�¥18 and â�¤65 years. 8. The patient, if a woman, must: - have had her last natural menstruation â�¥24 months prior to the Screening Visit, OR - have been surgically sterilized prior to the Screening Visit, OR - have had a hysterectomy prior to the Screening Visit, OR - agree not to try to become pregnant during the study, AND - use adequate, highly effective contraception (defined as those that result in a low failure rate [that is, 9. The patient, if a man, must: - use two methods of contraception in combination if his female partner is of childbearing potential; this combination of contraceptive methods must be used from the Baseline Visit until â�¥1 month after the last dose of IMP, OR have been surgically sterilized prior to the Screening Visit
Exclusion criteria
Exclusion criteria: 1. The patient has previously been enrolled in this study. 2. The patient has participated in a clinical study 3. The patient is a member of the study personnel or of their immediate families, or is a subordinate (or immediate family member of a subordinate) to any of the study personnel. 4. The subject has a significant risk of suicide according to the investigatorââ?¬•s clinical judgment or has made an actual suicide attempt in the previous 6 months prior to Screening.5. The patient is under forced treatment. 6. The patient previously received vortioxetine. 7. The patient is pregnant or breast-feeding. 8. The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity or intolerance to vortioxetine or its excipients. 9. The patient has any current psychiatric disorder or Axis I disorder (DSM-5Ã?® criteria), established as the primary diagnosis, other than MDD, as assessed using the Mini International Neuropsychiatric Interview (MINI) or another diagnostic interview. 10. The patient suffers from mental retardation, an organic mental disorder, or a mental disorder due to a general medical condition (DSM-5Ã?® criteria). 11. The patient has history of previous major depressive episodes considered as treatment resistant, defined as inadequate response (incomplete or no therapeutic response) to two prior courses of at least 6 weeks of conventional antidepressant drugs in adequate dosages patient has a current diagnosis or history of substance use (excluding nicotine and caffeine) or alcohol abuse (DSM-5Ã?® criteria) that has not been in sustained full remission at least 2 years prior to the Screening Visit. 13. The patient has any other disorder for which the treatment takes priority over treatment of MDD or is likely to interfere with study treatment or impair treatment compliance. 14. The patient has a history of moderate or severe head trauma or other neurological disorders or systemic medical diseases that are, in the investigatorââ?¬•s opinion, likely to affect central nervous system functioning. 15. The patient has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin, that has not been in remission for >5 years prior to the first dose of IMP. 16. The patient has or has had one or more of the following conditions that is/are considered clinically relevant in the context of the study: ââ?¬Â¢ neurological disorder ââ?¬Â¢ other psychiatric disorder ââ?¬Â¢ cardiovascular disease ââ?¬Â¢ seizure disorder or encephalopathy ââ?¬Â¢ congestive heart failure ââ?¬Â¢ cardiac hypertrophy ââ?¬Â¢ arrhythmia ââ?¬Â¢ bradycardia (pulse ââ?¬Â¢ respiratory disease ââ?¬Â¢ hepatic impairment or renal insufficiency ââ?¬Â¢ metabolic disorder ââ?¬Â¢ endocrinological disorder ââ?¬Â¢ gastrointestinal disorder ââ?¬Â¢ haematological disorder ââ?¬Â¢ infectious disorder ââ?¬Â¢ any clinically significant immunological condition ââ?¬Â¢ dermatological disorder ââ?¬Â¢ venereal disease ââ?¬Â¢ elevated intra-ocular pressure or is at risk of acute narrow-angle glaucoma 17. The patient takes or has taken recent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of flexible doses of vortioxetine (5 mg - 20 mg/day) over a period of 12 weeks in patients with MDD in IndiaTimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of flexible doses of vortioxetine (5 mg - 20 mg/day) over a period of 12 weeks in patients with MDD in India Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactSuneela Thatte
IQVIA RDS (India) Private Limited
Outcome results
None listed