A Efficacy and Safety Study of Lu AA21004 in Treating Generalized Anxiety 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:	NCT00730691

Purpose

The purpose of this study is to determine the safety and efficacy of Lu AA21004 in adults with generalized anxiety disorder.

Condition	Intervention	Phase
Generalized Anxiety Disorder	Drug: Lu AA21004 Drug: Duloxetine	Phase III

MedlinePlus related topics: Anxiety

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 3 Doses of Lu AA21004 in Acute Treatment of Adults With Generalized Anxiety Disorder

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

Primary Outcome Measures:

The least squares mean change from Baseline in the Hamilton Anxiety Scale total score. [ Time Frame: Week 8. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The least squares mean change from Baseline in the Hamilton Anxiety Scale total score at each week assessed. [ Time Frame: Weeks 0, 1, 2, 4, 6 and 8. ] [ Designated as safety issue: No ]
Response rates at Week 8, with response defined as a ≥50% decrease in the Hamilton Anxiety Scale total score from Baseline. [ Time Frame: Week 8. ] [ Designated as safety issue: No ]
Remission rates at Week 8, with remission defined as a Hamilton Anxiety Scale total score ≤7. [ Time Frame: Week 8. ] [ Designated as safety issue: No ]
The least squares mean change from Baseline in Clinical Global Impression Scale-Global Improvement. [ Time Frame: Weeks 1, 2, 4, 6 and 8. ] [ Designated as safety issue: No ]
The least squares mean change from Baseline in Clinical Global Impression Scale-Severity of Illness. [ Time Frame: Weeks 0, 1, 2, 4, 6 and 8. ] [ Designated as safety issue: No ]
The least squares mean change from Baseline in Hospital Anxiety and Depression Scale. [ Time Frame: Weeks 0, 1, 4 and 8. ] [ Designated as safety issue: No ]
Sheehan Disability Scale. [ Time Frame: Weeks 0, 1, 2, 4 and 8. ] [ Designated as safety issue: No ]
Healthcare resource utilization as assessed by the Health Economic Assessment Questionnaire. [ Time Frame: Weeks 0 and 8. ] [ Designated as safety issue: No ]

Estimated Enrollment:	750
Study Start Date:	June 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Lu AA21004 Lu AA21004 2.5 mg tablet, orally, once daily for up to 8 weeks.
2: Experimental	Drug: Lu AA21004 Lu AA21004 5 mg tablet, orally, once daily for up to 8 weeks.
3: Experimental	Drug: Lu AA21004 Lu AA21004 10 mg tablet, orally, once daily for up to 8 weeks.
4: Placebo Comparator	Drug: Lu AA21004 Lu AA21004 placebo-matching tablet, orally, once daily for up to 8 weeks.
5: Active Comparator	Drug: Duloxetine Duloxetine 60 mg tablet, orally, once daily for up to 8 weeks.

Detailed Description:

Subjects participating in this study will be randomly assigned to receive either 2.5 mg, 5 mg or 10 mg of Lu AA21004 once daily, 60 mg of duloxetine once daily, or a placebo once daily for eight weeks.

Subjects will be seen weekly during the first 2 weeks of treatment, and then every 2 weeks up to the end of the 8-week treatment period. Subjects who complete the 8-week treatment period will enter a 2-week discontinuation period in order to assess potential discontinuation symptoms. Total commitment time is up to 12 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Has a primary diagnosis of generalized anxiety disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR®) criteria (classification code 300.02).
Has a Hamilton Anxiety Scale total score ≥ 20. The subject has a Hamilton Anxiety Scale score ≥2 on both item 1 (anxious mood) and item 2 (tension).
Has a Montgomery-Åsberg Depression Rating Scale total score ≤16.

Exclusion Criteria:

Has 1 or more of the following:
- Any current psychiatric disorder other than Generalized Anxiety Disorder as defined in the DSM-IV-TR® (as assessed by the Mini International Neuropsychiatric Interview [MINI]).
- Current or past history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
- Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR® and subject must have a negative urine drug screen prior to Baseline.
- Presence or history of a clinically significant neurological disorder (including epilepsy).
- Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
- Any Axis II disorder that might compromise the study.
Has known sensitivity to duloxetine.
Is taking excluded medications
Has a significant risk of suicide according to the investigator's opinion or has a score ≥5 on item 10 (suicidal thoughts) of the Montgomery-Åsberg Depression Rating Scale or has made a suicide attempt in the previous 6 months.
Has previously failed to respond to adequate treatment with selective serotonin reuptake inhibitor and/or serotonin-norepinephrine reuptake inhibitors.
Has received electroconvulsive therapy within 6 months prior to Screening.
Is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.
Has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level >1.5 times the upper limit of normal.
Has a serum creatinine level >1.5 upper limit of normal.
Has a previous history of cancer that had been in remission for less than 5 years.
Has a history of lack of response to previous adequate treatment with duloxetine for any Generalized Anxiety Disorder episode.
Has a thyroid stimulating hormone value outside the normal range.
Has an abnormal electrocardiogram.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730691

Show 66 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:	LuAA21004_308
Study First Received:	August 6, 2008
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00730691
Health Authority:	United States: Food and Drug Administration

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

Generalized Anxiety Disorder
Mood Disorder
Affective Disorder
Anxiety Disorder
Drug Therapy

Study placed in the following topic categories:

Dopamine
Anxiety Disorders
Mental Disorders

Mood Disorders
Serotonin
Duloxetine

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs

Serotonin Uptake Inhibitors
Pharmacologic Actions
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009