Efficacy of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder

NCT00730691 | Completed Phase 3 Results

• 2 other identifiers: LuAA21004_308U1111-1114-3966
• Study Type: interventional
• Target: 781
• Locations: 1 country
• Sites: 66

Brief Summary

The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily (QD), in adults with generalized anxiety disorder.

Conditions

Generalized Anxiety Disorder

Keywords

Generalized Anxiety Disorder; Mood Disorder; Affective Disorder; Anxiety Disorder; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Hamilton Anxiety (HAM-A) Scale Total Score at Week 8

  The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.

  Baseline to Week 8

Secondary Outcomes (15)

• Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Week 8

  Baseline to Week 8

• Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Week 8

  Baseline to Week 8

• Change From Baseline in Sheehan Disability Scale (SDS) at Week 8

  Baseline to Week 8

• Percentage of Responders in HAM-A Total Score at Week 8

  Week 8

• Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25

  Baseline to Week 8

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Placebo-matching capsules, orally, once daily for up to 9 weeks.

Drug: Placebo

Vortioxetine 2.5 mg

EXPERIMENTAL

Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.

Drug: Placebo; Drug: Vortioxetine

Vortioxetine 5 mg

EXPERIMENTAL

Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.

Drug: Placebo; Drug: Vortioxetine

Vortioxetine 10 mg

EXPERIMENTAL

Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.

Drug: Placebo; Drug: Vortioxetine

Duloxetine 60 mg

ACTIVE COMPARATOR

Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.

Drug: Duloxetine

Interventions

Placebo DRUG

Placebo-matching capsules

Placebo; Vortioxetine 10 mg; Vortioxetine 2.5 mg; Vortioxetine 5 mg

Vortioxetine DRUG

Encapsulated vortioxetine immediate release tablets

Also known as: Lu AA21004, Brintellix®

Vortioxetine 10 mg; Vortioxetine 2.5 mg; Vortioxetine 5 mg

Duloxetine DRUG

Overencapsulated duloxetine capsules

Also known as: Cymbalta

Duloxetine 60 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. 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.

You may not qualify if:

• Had received any investigational compound \<30 days before Screening or 5 half-lives prior to Screening, whichever is longer.
• Received Lu AA21004 in a previous clinical study.
• Was a study site employee, or an immediate family member (ie, spouse, parent, child, or sibling) of a study site employee involved in conduct of this study.
• 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 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.

Sponsors & Collaborators

• Takeda: lead
• H. Lundbeck A/S: collaborator

Study Sites (66)

Unknown Facility

Anaheim, California, United States

Location

Unknown Facility

Beverly Hills, California, United States

Location

Unknown Facility

Fresno, California, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Oceanside, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Sherman Oaks, California, United States

Location

Unknown Facility

Widomar, California, United States

Location

Unknown Facility

Denver, Colorado, United States

Location

Unknown Facility

Farmington, Connecticut, United States

Location

Unknown Facility

Norwalk, Connecticut, United States

Location

Unknown Facility

Coral Gables, Florida, United States

Location

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

Maitland, Florida, United States

Location

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Orlando, Florida, United States

Location

Unknown Facility

Tampa, Florida, United States

Location

Unknown Facility

West Palm Beach, Florida, United States

Location

Unknown Facility

Winter Park, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Roswell, Georgia, United States

Location

Unknown Facility

Smyrna, Georgia, United States

Location

Unknown Facility

Honolulu, Hawaii, United States

Location

Unknown Facility

Oakbrook Ter, Illinois, United States

Location

Unknown Facility

Terre Haute, Indiana, United States

Location

Unknown Facility

Owensboro, Kentucky, United States

Location

Unknown Facility

Shreveport, Louisiana, United States

Location

Unknown Facility

Rockville, Maryland, United States

Location

Unknown Facility

Chesterfield, Missouri, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Nashua, New Hampshire, United States

Location

Unknown Facility

Clementon, New Jersey, United States

Location

Unknown Facility

Princeton, New Jersey, United States

Location

Unknown Facility

Albuquerque, New Mexico, United States

Location

Unknown Facility

Brooklyn, New York, United States

Location

Unknown Facility

Cedarhurst, New York, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Rochester, New York, United States

Location

Unknown Facility

Staten Island, New York, United States

Location

Unknown Facility

Charlotte, North Carolina, United States

Location

Unknown Facility

Raleigh, North Carolina, United States

Location

Unknown Facility

Beachwood, Ohio, United States

Location

Unknown Facility

Cleveland, Ohio, United States

Location

Unknown Facility

Dayton, Ohio, United States

Location

Unknown Facility

Toledo, Ohio, United States

Location

Unknown Facility

Eugene, Oregon, United States

Location

Unknown Facility

Portland, Oregon, United States

Location

Unknown Facility

Salem, Oregon, United States

Location

Unknown Facility

Allentown, Pennsylvania, United States

Location

Unknown Facility

Media, Pennsylvania, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Columbia, South Carolina, United States

Location

Unknown Facility

Memphis, Tennessee, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

DeSoto, Texas, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Lake Jackson, Texas, United States

Location

Unknown Facility

Wichita Falls, Texas, United States

Location

Unknown Facility

Midvale, Utah, United States

Location

Unknown Facility

Woodstock, Vermont, United States

Location

Unknown Facility

Richmond, Virginia, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

Unknown Facility

Brown Deer, Wisconsin, United States

Location

Unknown Facility

Middleton, Wisconsin, United States

Location

Unknown Facility

Milwaukee, Wisconsin, United States

Location

Related Publications (1)

• Mahableshwarkar AR, Jacobsen PL, Chen Y, Simon JS. A randomised, double-blind, placebo-controlled, duloxetine-referenced study of the efficacy and tolerability of vortioxetine in the acute treatment of adults with generalised anxiety disorder. Int J Clin Pract. 2014 Jan;68(1):49-59. doi: 10.1111/ijcp.12328.

  PMID: 24341301 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder; Mood Disorders; Anxiety Disorders

Interventions

Vortioxetine; Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiophenes; Sulfur Compounds; Organic Chemicals

Results Point of Contact

• Title: Medical Director, Clinical Science
• Organization: Takeda

clinicaltrialregistry@tpna.com

800-778-2860

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2008
• First Posted: August 8, 2008
• Study Start: June 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: December 18, 2013
• Results First Posted: December 18, 2013

Record last verified: 2013-10

Locations

US (66)