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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00766870

Enrollment

Registered

2008-10-06

Start date

2008-09-30

Completion date

2009-02-28

Last updated

2010-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

Efficacy, Safety, Depression, Interventional, Placebo, Short-term, Major Depressive Disorder, Major Depressive Episode

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.

Interventions

DRUGLu AA34893

Per oral doses, divided in twice daily administrations as capsules during 8 weeks, followed by a two-week tapering period

DRUGVenlafaxine extended release

Per oral, once daily, during 8 weeks, followed by a two-week tapering period

DRUGPlacebo

Per oral doses, twice daily as capsules during 10 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

In- and out-patients with moderate to severe Major Depressive Disorder Inclusion Criteria: * 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Depressive symptoms as measured by the change from baseline in MADRS total score	8 weeks

Secondary

Measure	Time frame
HAM-D, CGI, responders and remitters, HAM-A, adverse events, clinical safety laboratory tests, vital signs, weight, ECG, physical examination	8 weeks

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026