Long-term Study of Lu AA21004 in Patients With Major Depressive Disorder
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Purpose
The purpose of the study is to evaluate long-term safety and tolerability of Lu AA21004 over a period of 52 weeks in patients with Major Depressive Disorder having completed 6-week acute treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder |
Drug: Lu AA21004 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Long-term, Open-label Study Evaluating the Safety and Tolerability of Lu AA21004 in Patients With Major Depressive Disorder |
- Safety and tolerability assessed by adverse events, clinical safety laboratory tests, vital signs, weight, ECG and physical examination [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
- Maintenance of therapeutic effect [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Health related quality of life [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Pharmacokinetics [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 74 |
| Study Start Date: | June 2007 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Lu AA21004 |
Drug: Lu AA21004
5-10 mg/day
Other Name: Vortioxetine
|
Detailed Description:
Depression is a common mental disorder that presents with depressed mood, loss of interest or pleasure, disturbed sleep or appetite, low energy, feelings of guilt or low self-worth, and poor concentration. Depression may become chronic or recurrent and lead to substantial impairments in an individual's ability to take care of his or her everyday responsibilities. The need for the treatment of the depressive episode beyond the acute period of treatment has been well documented and the duration of treatment is of at least 6 months. The adverse event profile plays a large role in the choice of antidepressant therapy and the compliance during long-term treatment.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients who completed 6-week short-term treatment study for Major Depressive Episode followed by a 2-week taper period
Exclusion Criteria:
- Any current psychiatric disorder other than MDD as defined in the DSM-IV TR
- Female patients of childbearing potential who are not using effective contraception
- Use of any psychoactive medication
Other protocol-defined inclusion and exclusion criteria may apply
Contacts and Locations More Information
No publications provided
| Responsible Party: | H. Lundbeck A/S |
| ClinicalTrials.gov Identifier: | NCT00761306 History of Changes |
| Other Study ID Numbers: | 11492C, 2007-000905-31 |
| Study First Received: | September 26, 2008 |
| Last Updated: | June 18, 2012 |
| Health Authority: | Australia: National Health and Medical Research Council Canada: Health Canada Czech Republic: State Institute for Drug Control Finland: Finnish Medicines Agency Italy: The Italian Medicines Agency Malaysia: Ministry of Health Slovakia: State Institute for Drug Control Sweden: Medical Products Agency |
Keywords provided by H. Lundbeck A/S:
|
Major Depressive Disorder Long-term Safety Open-label |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major |
Mood Disorders Mental Disorders Behavioral Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013