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

NCT00731120 | Completed Phase 3 Results

• 2 other identifiers: LuAA21004_309U1111-1114-2380
• Study Type: interventional
• Target: 457
• Locations: 1 country
• Sites: 40

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of 2.5 mg and 10 mg 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 Scale (HAM-A) Total Score

  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 an analysis of covariance (ANCOVA) model with treatment and center as fixed factors and the Baseline value as a covariate.

  Baseline and Week 8

Secondary Outcomes (9)

• Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed

  Baseline and Weeks 1, 2, 4 and 6

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

  Baseline and Week 8

• Percentage of Participants in HAM-A Remission at Week 8

  Week 8

• Clinical Global Impression Scale-Global Improvement (CGI-I) at Each Week Assessed

  Baseline and Weeks 1, 2, 4, 6 and 8.

• Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)

  Baseline and Weeks 1, 2, 4, 6 and 8.

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.

Drug: Placebo

Vortioxetine 2.5 mg

EXPERIMENTAL

Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks.

Drug: Vortioxetine

Vortioxetine 10 mg

EXPERIMENTAL

Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.

Drug: Vortioxetine

Interventions

Vortioxetine DRUG

Encapsulated vortioxetine immediate-release tablets

Also known as: Lu AA21004, Brintellix®

Vortioxetine 10 mg; Vortioxetine 2.5 mg

Placebo DRUG

Vortioxetine placebo-matching capsules

Placebo

Eligibility Criteria

• Age: 18 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 Diagnostic and Statistical Manual of Mental Disorders, 4th 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:

• 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 participant 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.
• 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 inhibitors 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 clinically significant unstable illness.
• Has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level \> 1.5 times the upper limit of normal.
• Has a serum creatinine of \> 1.5 × the upper limit of normal.

Sponsors & Collaborators

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

Study Sites (40)

Unknown Facility

Birmingham, Alabama, United States

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Anaheim, California, United States

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Cerritos, California, United States

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Costa Mesa, California, United States

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Orange, California, United States

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Redlands, California, United States

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Cromwell, Connecticut, United States

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Norwich, Connecticut, United States

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Hockessin, Delaware, United States

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Fort Myers, Florida, United States

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Jacksonville, Florida, United States

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Lady Lake, Florida, United States

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Miami, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Libertyville, Illinois, United States

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Valparaiso, Indiana, United States

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Overland Park, Kansas, United States

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Prairie Village, Kansas, United States

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Boston, Massachusetts, United States

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Braintree, Massachusetts, United States

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Pittsfield, Massachusetts, United States

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St Louis, Missouri, United States

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Cherry Hill, New Jersey, United States

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Fresh Meadows, New York, United States

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New York, New York, United States

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Olean, New York, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Middleburg Heights, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Emmaus, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Reading, Pennsylvania, United States

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North Charleston, South Carolina, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Midlothian, Virginia, United States

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Waukesha, Wisconsin, United States

Location

Related Publications (1)

• Mahableshwarkar AR, Jacobsen PL, Serenko M, Chen Y. A randomized, double-blind, fixed-dose study comparing the efficacy and tolerability of vortioxetine 2.5 and 10 mg in acute treatment of adults with generalized anxiety disorder. Hum Psychopharmacol. 2014 Jan;29(1):64-72. doi: 10.1002/hup.2371.

  PMID: 24424707 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder; Mood Disorders; Anxiety Disorders

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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: January 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 (40)