A Study of 15 and 20 mg of Lu AA21004 in Major Depressive Disorder
This study has been completed.
Sponsor:
H. Lundbeck A/S
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT01323478
First received: March 24, 2011
Last updated: October 26, 2012
Last verified: October 2012
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Purpose
To evaluate the long-term safety and tolerability of flexible doses, 15 and 20 mg/day, of Lu AA21004 over a period of 52 weeks in patients with Major Depressive Disorder (MDD)
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder |
Drug: Lu AA21004 |
Phase 3 |
| 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, Flexible-dose, Extension Study Evaluating the Safety and Tolerability of Lu AA21004 (15 and 20 mg/Day) in Patients With Major Depressive Disorder |
Resource links provided by NLM:
Further study details as provided by H. Lundbeck A/S:
Primary Outcome Measures:
- To evaluate the long-term safety and tolerability of flexible doses of Lu AA21004 (15 and 20 mg/day) over a period of 52 weeks in patients with MDD who have completed the lead-in Study 13267A. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To evaluate the therapeutic effect of flexible doses of Lu AA21004 (15 and 20 mg/day) over a period of 52 weeks in patients with MDD as assessed by MADRS. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]MADRS: Montgomery and Åsberg Depression Rating Scale
- To evaluate the therapeutic effect of flexible doses of Lu AA21004 (15 and 20 mg/day) over a period of 52 weeks in patients with MDD as assessed by CGI-S. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]CGI-S: Clinical Global Impression Scale-Severity of Illness
- To evaluate the therapeutic effect of flexible doses of Lu AA21004 (15 and 20 mg/day) over a period of 52 weeks in patients with MDD as assessed by HAM-A. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]HAM-A: Hamilton Anxiety Rating Scale
| Enrollment: | 71 |
| Study Start Date: | April 2011 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Lu AA21004 flexible dose 15 - 20 mg/day |
Drug: Lu AA21004
Flexible dose 15 - 20 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 usually set at about 6 months. The adverse event profile plays a large role in the choice of antidepressant therapy and safety aspects of a drug in relation to the duration of treatment have to be addressed.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients who completed 8-week short-term treatment study (Protocol ID 13267A) for Major Depressive Episode immediately prior to enrolment in this extension study
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01323478
Locations
| Belgium | |
| BE001 | |
| Liège, Belgium, 4000 | |
| Estonia | |
| EE001 | |
| Tallinn, Estonia, 10617 | |
| EE002 | |
| Tallinn, Estonia, 11615 | |
| Finland | |
| FI003 | |
| Kuopio, Finland, 70110 | |
| FI006 | |
| Kuopio, Finland, 70110 | |
| FI007 | |
| Tampera, Finland, 33100 | |
| Latvia | |
| LV001 | |
| Liepaja, Latvia, 3400 | |
| LV003 | |
| Sigulda, Latvia, 2150 | |
| Norway | |
| NO001 | |
| Skien, Norway, 3725 | |
| Slovakia | |
| SK004 | |
| Bratislava, Slovakia, 81107 | |
| SK006 | |
| Bratislava, Slovakia, 82007 | |
| SK002 | |
| Michalovce, Slovakia, 07101 | |
| Sweden | |
| SE004 | |
| Malmø, Sweden, 21152 | |
| SE001 | |
| Stockholm, Sweden, 11164 | |
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
| Study Director: | Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com |
More Information
No publications provided
| Responsible Party: | H. Lundbeck A/S |
| ClinicalTrials.gov Identifier: | NCT01323478 History of Changes |
| Other Study ID Numbers: | 13267B, 2010-024198-38 |
| Study First Received: | March 24, 2011 |
| Last Updated: | October 26, 2012 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products Estonia: The State Agency of Medicine Finland: Finnish Medicines Agency Latvia: State Agency of Medicines Norway: Norwegian Medicines Agency Slovenia: Agency for Medicinal Products - Ministry of Health Sweden: Medical Products Agency |
Keywords provided by H. Lundbeck A/S:
|
Depressive Disorder Depression Depressive Disorder, Major |
Mood Disorders Mental Disorders Behavioural Symptoms |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major |
Mood Disorders Mental Disorders Behavioral Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013