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

NCT ID: NCT00766870

Last Updated: 2010-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-02-28

Brief Summary

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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

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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.

Conditions

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Major Depressive Disorder

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

Lu AA34893

Intervention Type DRUG

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

2

Group Type EXPERIMENTAL

Lu AA34893

Intervention Type DRUG

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

3

Group Type EXPERIMENTAL

Lu AA34893

Intervention Type DRUG

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

4

Group Type OTHER

Venlafaxine extended release

Intervention Type DRUG

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

5

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Per oral doses, twice daily as capsules during 10 weeks

Interventions

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Lu AA34893

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

Intervention Type DRUG

Venlafaxine extended release

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

Intervention Type DRUG

Placebo

Per oral doses, twice daily as capsules during 10 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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H. Lundbeck A/S

Principal Investigators

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Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

[email protected]

Locations

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CA009

Mississauga, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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2007-007025-51

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

12279A

Identifier Type: -

Identifier Source: org_study_id