Efficacy and Safety of Vortioxetine (Lu AA21004) for Treatment of Generalized Anxiety Disorder in Adults.

NCT00744627 | Completed Phase 3 Results

• 3 other identifiers: LuAA21004_3112008-001766-90U1111-1112-3487
• Study Type: interventional
• Target: 301
• Locations: 8 countries
• Sites: 38

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of vortioxetine, once daily (QD), in adults with Generalized Anxiety Disorders.

Conditions

Generalized Anxiety Disorder

Keywords

Generalized Anxiety Disorder; Anxiety Disorders; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Hamilton Anxiety Scale (HAM-A) 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 Baseline-by-week, center, week and week-by-treatment as factors in the analysis.

  Baseline to Week 8

Secondary Outcomes (24)

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

  Baseline to Week 8

• Clinical Global Impression Scale-Global Improvement at Week 8

  Baseline to Week 8

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

  Baseline to Week 8

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

  Baseline and 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 (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Vortioxetine 5 mg

EXPERIMENTAL

Vortioxetine 5 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 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:

• Suffers from a primary diagnosis of Generalized Anxiety Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
• Has a Hamilton Anxiety Scale total score ≥20 at Screening and Baseline.
• Has a Hamilton Anxiety Scale score ≥2 on both Item 1 (anxious mood) and Item 2 (tension) at Screening and Baseline.
• Has a Montgomery-Åsberg Depression Rating Scale total score ≤16 at Screening and Baseline.
• Male and females of childbearing potential who are sexually active agree to use adequate contraception from Screening throughout the duration of the study and for 1 month after the last dose of study medication.

You may not qualify if:

• Has received any investigational compound \<30 days before Screening or 5 half-lives prior to Screening.
• Has received Lu AA21004 in a previous clinical study or as a therapeutic agent.
• Has 1 or more of the following:
• Any current psychiatric disorder other than Generalized Anxiety Disorder as defined in the DSM-IV-TR.
• 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.
• Presence or history of a clinically significant neurological disorder (including epilepsy).
• Neurodegenerative disorder (Alzheimer's disease, Parkinson's disease, multiple sclerosis, Huntington disease, etc).
• Any Axis II disorder that might compromise the study.
• Is required to take excluded medications or it is anticipated that the participant will require treatment with at least 1 of the disallowed concomitant medications during the study including:
• Nonsteroidal anti-inflammatory drugs
• Rifampin
• Macrolide antibiotics
• Hormones
• Hypoglycemic agents and Insulin

Sponsors & Collaborators

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

Study Sites (38)

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Tallinn, Estonia

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Viljandi, Estonia

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Bad Saarow, Germany

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Berlin, Germany

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Bochum, Germany

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Hüttenberg, Germany

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Rodgau, Germany

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Schwerin, Germany

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Wiesbaden, Germany

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Liepāja, Latvia

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Riga, Latvia

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Sigulda, Latvia

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Kaunas, Lithuania

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Palanga, Lithuania

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Vilnius, Lithuania

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Bialystok, Poland

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Gdynia, Poland

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Gorlice, Poland

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Leszno, Poland

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Skórzewo, Poland

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Torun, Poland

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Tuszyn, Poland

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Bucharest, Romania

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Oradea, Romania

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Kazan', Russia

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Lipetsk, Russia

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Moscow, Russia

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Rostov-on-Don, Russia

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Saint Petersburg, Russia

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Samara, Russia

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Smolensk, Russia

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Stavropol, Russia

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Yekaterinburg, Russia

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Dnipro, Ukraine

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Kharkiv, Ukraine

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Liev, Ukraine

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Luhansk, Ukraine

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Simferopol, Ukraine

Location

Related Publications (2)

• Bidzan L, Mahableshwarkar AR, Jacobsen P, Yan M, Sheehan DV. Vortioxetine (Lu AA21004) in generalized anxiety disorder: results of an 8-week, multinational, randomized, double-blind, placebo-controlled clinical trial. Eur Neuropsychopharmacol. 2012 Dec;22(12):847-57. doi: 10.1016/j.euroneuro.2012.07.012. Epub 2012 Aug 14.

  PMID: 22898365 RESULT

• Christensen MC, Loft H, Florea I, McIntyre RS. Efficacy of vortioxetine in working patients with generalized anxiety disorder. CNS Spectr. 2019 Apr;24(2):249-257. doi: 10.1017/S1092852917000761. Epub 2017 Oct 30.

  PMID: 29081307 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder; 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2008
• First Posted: September 1, 2008
• Study Start: September 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: March 3, 2014
• Results First Posted: March 3, 2014

Record last verified: 2014-01

Locations

RO (2); RU (9); UA (5); LI (3); LA (3); DE (7); PL (7); ES (2)