Study Stopped
Study was previously paused and is now terminated
Efficacy and Safety of Lu AA34893 in Patients With Major Depressive Disorder
A Randomised, Double-blind, Parallel-group, Placebo-controlled, and Active-referenced Study Evaluating the Efficacy and Safety of Three Fixed Dose Regimens of Lu AA34893 in the Treatment of Major Depressive Disorder
2 other identifiers
interventional
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 major-depressive-disorder
Started Sep 2008
Shorter than P25 for phase_2 major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 3, 2008
CompletedFirst Posted
Study publicly available on registry
October 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedSeptember 29, 2010
September 1, 2010
4 months
October 3, 2008
September 28, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Depressive symptoms as measured by the change from baseline in MADRS total score
8 weeks
Secondary Outcomes (1)
HAM-D, CGI, responders and remitters, HAM-A, adverse events, clinical safety laboratory tests, vital signs, weight, ECG, physical examination
8 weeks
Study Arms (5)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTAL4
OTHER5
PLACEBO COMPARATORInterventions
Per oral doses, divided in twice daily administrations as capsules during 8 weeks, followed by a two-week tapering period
Per oral, once daily, during 8 weeks, followed by a two-week tapering period
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
Study Sites (1)
CA009
Mississauga, Ontario, ON L5M 4N4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@lundbeck.com
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 3, 2008
First Posted
October 6, 2008
Study Start
September 1, 2008
Primary Completion
January 1, 2009
Study Completion
February 1, 2009
Last Updated
September 29, 2010
Record last verified: 2010-09