A Safety and Tolerability Study of Lu AA21004 in Subjects With Major Depressive Disorder - Full Text View

Sponsors and Collaborators:	Takeda Global Research & Development Center, Inc. H. Lundbeck A/S
Information provided by:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00707980

Purpose

The purpose of this study is to determine the long-term efficacy and safety of Lu AA21004 in adults with major depressive disorder.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: Lu AA21004	Phase III

MedlinePlus related topics: Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Long-Term, Open-Label, Flexible-Dose, Extension Study Evaluating the Safety and Tolerability of Lu AA21004 in Subjects With Major Depressive Disorder

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:

Physical Examination [ Time Frame: Weeks 4, 12, 24, 36 and Final Visit ] [ Designated as safety issue: Yes ]
Clinical Laboratory Data (chemistry, hematology and urinalysis) [ Time Frame: Weeks 4, 8, 12, 20, 28, 36, 44 and Final Visit ] [ Designated as safety issue: Yes ]
Electrocardiogram [ Time Frame: Weeks 4, 12, 24, 36 and Final Visit ] [ Designated as safety issue: Yes ]
Adverse Events [ Time Frame: At All Visits ] [ Designated as safety issue: Yes ]
Vital Signs and Body Weight [ Time Frame: At All Visits ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Mean change from Baseline in Hamilton Depression Scale-24 Item total score. [ Time Frame: At All Visits ] [ Designated as safety issue: No ]
Medical Outcomes Study 36-item Short Form, each of the 8 subscales separately. [ Time Frame: Weeks: 24 and Final Visit ] [ Designated as safety issue: No ]
Sheehan Disability Scale [ Time Frame: Weeks: 24 and Final Visit ] [ Designated as safety issue: No ]
Health Economic Assessment Questionnaire [ Time Frame: Weeks: 24 and Final Visit ] [ Designated as safety issue: No ]
Mean change from Baseline in the Montgomery Åsberg Depression Rating Scale total score [ Time Frame: Weeks 4, 24 and Final Visit ] [ Designated as safety issue: No ]
Mean change from Baseline in the Hamilton Anxiety Scale total score [ Time Frame: Weeks 4, 24 and Final Visit ] [ Designated as safety issue: No ]
Mean change from Baseline in the Clinical Global Impression of Severity of Illness scale. [ Time Frame: Weeks 4, 24 and Final Visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	840
Study Start Date:	June 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1.: Experimental	Drug: Lu AA21004 2.5 mg, 5 mg or 10 mg tablet, orally, once daily for up to 52 weeks.

Detailed Description:

Depression has been recognized as a chronic illness that imposes a significant burden on individuals, families and society. Major depressive disorder is among the most important causes of disability worldwide, in both developing and developed countries. Major depressive disorder is reported to be the most common mood disorder, with a lifetime prevalence of about 15% and as high as 25% in women. Major depressive disorder is characterized by the presence of 1 or more major depressive episodes 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. Studies suggest that at least 70% of depressed patients also report somatic symptoms such as pain, shortness of breath, fatigue, or nausea. A number of patients may present with somatic symptoms as the main complaint rather than depressed mood. Depression is recurrent in 75% to 80% of patients, becomes chronic (ie, lasting 2 years or longer) in 15% to 20% of depressed patients, and can lead to substantial impairments in an individual's ability to take care of his or her everyday responsibilities. Furthermore, depression may lead to suicide and the mortality due to suicide is approximately 15% among patients treated by psychiatrists. Major depressive disorder imposes a socioeconomic burden comparable to chronic medical illnesses in terms of healthcare utilization, decreased productivity, and dysfunctional family life, and is associated with an increased consumption of general medical, psychiatric and emergency services.

Lu AA21004 is a compound under development by Takeda Pharmaceutical Company Limited and H. Lundbeck A/S with clinical development for the treatment of major depressive disorder.

Eligibility

Ages Eligible for Study:	18 Years to 76 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The subject has completed the double blind treatment period of either study Lu AA21004_304 or Lu AA21004_305 immediately prior to enrollment in the extension study (ie, the baseline visit is the same visit as the completion visit of the double blind treatment of the preceding protocol).
The subject suffers from a major depressive episode as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.xx) at entry into the prior Lu AA21004_304 or Lu AA21004_305 study.

Exclusion Criteria:

In addition to meeting the exclusion criteria for studies Lu AA21004_304 or Lu AA21004_305 at the time of enrollment into those studies respectively, with the exception of the criteria prohibiting previous exposure to Lu AA21004 and investigational drugs, and the criteria prohibiting patients with increased intraocular pressure, or risk of acute narrow-angle glaucoma, the following exclusion criteria apply:
- The subject with Major Depressive Disorder for whom other psychiatric disorders (mania, bipolar disorder, schizophrenia, or any psychotic disorder) have been diagnosed during the prior study.
- The subject, in the investigator's opinion, has a significant risk of suicide and/or a score of ≥5 points on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale.
- The subject, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
- The patient has a clinically significant moderate or severe ongoing adverse event related to study medication from the prior study.
- The subject has used/uses disallowed concomitant medication.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00707980

Show 38 Study Locations

Sponsors and Collaborators

Takeda Global Research & Development Center, Inc.

H. Lundbeck A/S

Investigators

Study Director:

Medical Director

Takeda Global Research & Development Center, Inc.

More Information

Responsible Party:	Takeda Global Research & Development Center, Inc. ( Sr. VP, Clinical Science )
Study ID Numbers:	Lu AA21004_301, 2008-001581-91
Study First Received:	June 27, 2008
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00707980
Health Authority:	United States: Food and Drug Administration

Keywords provided by Takeda Global Research & Development Center, Inc.:

Major Depressive Disorder
Depression
Melancholia

Mood Disorder
Dysthymic Disorder
Drug Therapy

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders
Dysthymic Disorder

Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 16, 2009