Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

25 oktober 2013 uppdaterad av: Takeda

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses of Lu AA21004 in Acute Treatment of Adults With Generalized Anxiety Disorder

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Participants in this study will be randomly assigned to receive either 2.5 mg or 10 mg of vortioxetine or a placebo once daily for an eight week treatment period.

Participants 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. Total commitment time is up to 12 weeks.

Studietyp

Interventionell

Inskrivning (Faktisk)

457

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Alabama
      • Birmingham, Alabama, Förenta staterna
    • California
      • Anaheim, California, Förenta staterna
      • Cerritos, California, Förenta staterna
      • Costa Mesa, California, Förenta staterna
      • Orange, California, Förenta staterna
      • Redlands, California, Förenta staterna
    • Connecticut
      • Cromwell, Connecticut, Förenta staterna
      • Norwich, Connecticut, Förenta staterna
    • Delaware
      • Hockessin, Delaware, Förenta staterna
    • Florida
      • Fort Myers, Florida, Förenta staterna
      • Jacksonville, Florida, Förenta staterna
      • Lady Lake, Florida, Förenta staterna
      • Miami, Florida, Förenta staterna
    • Georgia
      • Atlanta, Georgia, Förenta staterna
    • Illinois
      • Chicago, Illinois, Förenta staterna
      • Libertyville, Illinois, Förenta staterna
    • Indiana
      • Valparaiso, Indiana, Förenta staterna
    • Kansas
      • Overland Park, Kansas, Förenta staterna
      • Prairie Village, Kansas, Förenta staterna
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna
      • Braintree, Massachusetts, Förenta staterna
      • Pittsfield, Massachusetts, Förenta staterna
    • Missouri
      • St Louis, Missouri, Förenta staterna
    • New Jersey
      • Cherry Hill, New Jersey, Förenta staterna
    • New York
      • Fresh Meadows, New York, Förenta staterna
      • New York, New York, Förenta staterna
      • Olean, New York, Förenta staterna
    • Ohio
      • Cincinnati, Ohio, Förenta staterna
      • Columbus, Ohio, Förenta staterna
      • Middleburg Heights, Ohio, Förenta staterna
    • Oklahoma
      • Oklahoma City, Oklahoma, Förenta staterna
    • Pennsylvania
      • Emmaus, Pennsylvania, Förenta staterna
      • Philadelphia, Pennsylvania, Förenta staterna
      • Reading, Pennsylvania, Förenta staterna
    • South Carolina
      • North Charleston, South Carolina, Förenta staterna
    • Tennessee
      • Nashville, Tennessee, Förenta staterna
    • Texas
      • Houston, Texas, Förenta staterna
      • San Antonio, Texas, Förenta staterna
    • Virginia
      • Midlothian, Virginia, Förenta staterna
    • Wisconsin
      • Waukesha, Wisconsin, Förenta staterna

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • 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.

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 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.
  • Has a previous history of cancer that had been in remission for less than 5 years.
  • Has thyroid stimulating hormone value outside the normal range.
  • Has an abnormal electrocardiogram.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: Placebo
Vortioxetin placebo-matchande kapslar, oralt, en gång dagligen i upp till 8 veckor.
Läkemedel: Placebo
Vortioxetin placebo-matchande kapslar
Experimentell: Vortioxetine 2.5 mg
Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks.
Läkemedel: Vortioxetin
Inkapslade vortioxetin tabletter med omedelbar frisättning
Andra namn:
  • Lu AA21004
  • Brintellix®
Experimentell: Vortioxetine 10 mg
Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
Läkemedel: Vortioxetin
Inkapslade vortioxetin tabletter med omedelbar frisättning
Andra namn:
  • Lu AA21004
  • Brintellix®

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score
Tidsram: Baseline and 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 an analysis of covariance (ANCOVA) model with treatment and center as fixed factors and the Baseline value as a covariate.
Baseline and Week 8

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed
Tidsram: Baseline and Weeks 1, 2, 4 and 6
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. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.
Baseline and Weeks 1, 2, 4 and 6
Percentage of Responders in HAM-A Total Score at Week 8
Tidsram: Baseline and Week 8
Response was defined as a participant with a ≥50% decrease from Baseline in the 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 (symptoms absent) to 56 (maximum severity).
Baseline and Week 8
Percentage of Participants in HAM-A Remission at Week 8
Tidsram: Week 8
Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. 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 (symptoms absent) to 56 (maximum severity).
Week 8
Clinical Global Impression Scale-Global Improvement (CGI-I) at Each Week Assessed
Tidsram: Baseline and Weeks 1, 2, 4, 6 and 8.
The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from an ANCOVA model adjusting for Baseline CGI-S score, center, and treatment.
Baseline and Weeks 1, 2, 4, 6 and 8.
Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)
Tidsram: Baseline and Weeks 1, 2, 4, 6 and 8.
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from an ANCOVA model adjusting for Baseline score, center, and treatment.
Baseline and Weeks 1, 2, 4, 6 and 8.
Change From Baseline in Hospital Anxiety and Depression (HAD) Scales
Tidsram: Baseline and Weeks 1, 4 and 8.
The HAD scale is completed by the participant and comprises two subscales, one measuring depression (focusing on the state of lost interest and diminished pleasure response) and one measuring anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Each subscale is made up of 7 items that are assessed on a scale of 0 = no anxiety/depression to 3 = severe feeling of anxiety/depression. Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores for the depression and anxiety subscales are summed separately and not combined, with each score ranging from 0 to 21 (maximal severity). LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.
Baseline and Weeks 1, 4 and 8.
Change From Baseline in Sheehan Disability Scale (SDS) at Week 8
Tidsram: Baseline and Week 8
The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.
Baseline and Week 8
Change From Baseline in 36-item Short-form Health Survey (SF-36)
Tidsram: Baseline and Week 8
The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The 8 health concepts are: 1. Limitation in physical activities because of health problems. 2. Limitations in usual role activities because of physical health problems. 3. Bodily pain. 4. Limitations in social activities because of physical or emotional problems. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perception. Each scale ranges from 0 (best) - 100 (worst). LS means were from an ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.
Baseline and Week 8
Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire
Tidsram: Baseline and Week 8
Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.
Baseline and Week 8

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Takeda

Samarbetspartners

H. Lundbeck A/S

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juni 2008

Primärt slutförande (Faktisk)

1 januari 2009

Avslutad studie (Faktisk)

1 februari 2009

Studieregistreringsdatum

Först inskickad

6 augusti 2008

Först inskickad som uppfyllde QC-kriterierna

6 augusti 2008

Första postat (Uppskatta)

8 augusti 2008

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

18 december 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 oktober 2013

Senast verifierad

1 oktober 2013

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • LuAA21004_309
  • U1111-1114-2380 (Registeridentifierare: WHO)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Generaliserat ångestsyndrom

Kliniska prövningar på Placebo

Sök liknande försök

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

CROs by country

CROs in Turkmenistan

Betingelser

Sällsynta sjukdomar

Läkemedelsinterventioner

Kosttillskott

Sponsor / medarbetare

Platser

3
Prenumerera