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

25 ottobre 2013 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

457

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo
Vortioxetina capsule corrispondenti al placebo, per via orale, una volta al giorno per un massimo di 8 settimane.
Droga: Placebo
Vortioxetina capsule corrispondenti al placebo
Sperimentale: Vortioxetine 2.5 mg
Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks.
Droga: Vortioxetina
Compresse incapsulate a rilascio immediato di vortioxetina
Altri nomi:
  • Lu AA21004
  • Brintellix®
Sperimentale: Vortioxetine 10 mg
Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
Droga: Vortioxetina
Compresse incapsulate a rilascio immediato di vortioxetina
Altri nomi:
  • Lu AA21004
  • Brintellix®

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Takeda

Collaboratori

H. Lundbeck A/S

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2008

Completamento primario (Effettivo)

1 gennaio 2009

Completamento dello studio (Effettivo)

1 febbraio 2009

Date di iscrizione allo studio

Primo inviato

6 agosto 2008

Primo inviato che soddisfa i criteri di controllo qualità

6 agosto 2008

Primo Inserito (Stima)

8 agosto 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

18 dicembre 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 ottobre 2013

Ultimo verificato

1 ottobre 2013

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • LuAA21004_309
  • U1111-1114-2380 (Identificatore di registro: WHO)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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