Efficacy and Safety of Lu AA34893 in Patients With Major Depressive Disorder
- Conditions
- Major Depressive Disorder
- Interventions
- Registration Number
- NCT00766870
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
The purpose of the study is to evaluate the efficacy, safety and tolerability of three fixed dosages of Lu AA34893 compared to placebo in the treatment of patients with Major Depressive Disorder.
- Detailed Description
Major Depressive Disorder (MDD) is reported to be the most common mood disorder, with a lifetime prevalence of about 15% and as high as 25% in women. MDD is characterised by the presence of one or more Major Depressive Episodes (MDEs) 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. MDD is a disabling, severe illness that tends to be chronic, and repeated episodes are common. Despite the availability of a range of effective treatments in MDD, a significant proportion of patients do not respond or achieve remission and many relapse despite continued treatment. Lu AA34893 has a novel mechanism of action and this could be of clinical relevance in addressing currently unmet needs in MDD.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 35
- Major Depressive Episode (MDE) as primary diagnosis according to DSM-IV (classification code 296.xx)
- Moderate to severe depression
- Current MDE duration of at least 3 months
- Any current psychiatric disorder other than MDD as defined in the DSM-IV TR
- Any substance disorder within the previous 6 months
- Females of childbearing potential and not using adequate contraception
- Use of any psychoactive medication within 2 weeks before randomisation and during the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Lu AA34893 - 2 Lu AA34893 - 3 Lu AA34893 - 4 Venlafaxine extended release - 5 Placebo -
- Primary Outcome Measures
Name Time Method Depressive symptoms as measured by the change from baseline in MADRS total score 8 weeks
- Secondary Outcome Measures
Name Time Method HAM-D, CGI, responders and remitters, HAM-A, adverse events, clinical safety laboratory tests, vital signs, weight, ECG, physical examination 8 weeks
Trial Locations
- Locations (1)
CA009
🇨🇦Mississauga, Ontario, Canada