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

Primary Purpose

Major Depressive Disorder

Status

Terminated

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Lu AA34893

Venlafaxine extended release

Placebo

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Efficacy, Safety, Depression, Interventional, Placebo, Short-term, Major Depressive Disorder, Major Depressive Episode

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CA009

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Other

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Depressive symptoms as measured by the change from baseline in MADRS total score

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00766870

First Posted

October 3, 2008

Last Updated

September 28, 2010

Sponsor

H. Lundbeck A/S

1. Study Identification

Unique Protocol Identification Number

NCT00766870

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Terminated

Why Stopped

Study was previously paused and is now terminated

Study Start Date

September 2008 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

H. Lundbeck A/S

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Other

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Lu AA34893

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Venlafaxine extended release

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Per oral doses, twice daily as capsules during 10 weeks

Primary Outcome Measure Information:

Title

Depressive symptoms as measured by the change from baseline in MADRS total score

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Email contact via H. Lundbeck A/S

Organizational Affiliation

LundbeckClinicalTrials@lundbeck.com

Official's Role

Study Director

Facility Information:

Facility Name

CA009

City

Mississauga

State/Province

Ontario

ZIP/Postal Code

ON L5M 4N4

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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