Efficacy and Safety of Lu AA34893 in Patients With Major Depressive Disorder

Lundbeck

Status and phase: Terminated; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: Placebo; Drug: Lu AA34893; Drug: Venlafaxine extended release

Study type: Interventional

Funder types: Industry

Identifiers

NCT00766870

12279A

2007-007025-51 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 5 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Lu AA34893

2

Experimental group

Treatment:

Drug: Lu AA34893

3

Experimental group

Treatment:

Drug: Lu AA34893

4

Other group

Treatment:

Drug: Venlafaxine extended release

5

Placebo Comparator group

Treatment:

Drug: Placebo