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Study of the Effectiveness of Three Different Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia (VECTOR)

29 settembre 2015 aggiornato da: Otsuka Pharmaceutical Development & Commercialization, Inc.

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Three Fixed Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia

The purpose of this study is to compare the effectiveness, safety and tolerability of three different doses of OPC-34712 with placebo in the treatment of acute schizophrenia in adults.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Schizophrenia is a severely debilitating mental illness that affects approximately 1% of the world population. Hallucinations and delusions are the most striking characteristic positive symptoms of schizophrenia; however, more subtle negative symptoms (eg, social withdrawal and lack of emotion, energy, and motivation) may also be present. The first antipsychotics developed for the treatment of schizophrenia were effective against positive symptoms, but showed little efficacy for negative symptoms and were also associated with a high incidence of side effects. Second generation antipsychotics, represent a significant advancement in the treatment of psychotic disorders because they are effective and at the same time exhibit fewer side effects than first generation antipsychotics. Although generally safer than first generation antipsychotics, the second-generation antipsychotics are not devoid of undesirable side effects such as Hyperprolactinemia and weight gain. In addition, the safety of these drugs vary considerably.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

636

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

  • Canada
    • Ontario
      • Burlington, Ontario, Canada, L7R 4E2
      • Chatham, Ontario, Canada, N7M 5L9
      • Chatham, Ontario, Canada, N7L 1B7
  • Corea, Repubblica di
      • Incheon, Corea, Repubblica di, 405-760
      • Incheon, Corea, Repubblica di, 400-711
      • Seoul, Corea, Repubblica di, 136-705
      • Seoul, Corea, Repubblica di, 137-710
      • Seoul, Corea, Repubblica di, 143-711
  • Giappone
      • Kumamoto-shi, Giappone, 861-8002
    • Kanagawa-Ken
      • Fujisawa-shi, Kanagawa-Ken, Giappone, 251-8530
    • Okinawa-Ken
      • Kunigami-gun, Okinawa-Ken, Giappone, 904-1201
    • Osaka-Fu
      • Sakai-shi, Osaka-Fu, Giappone, 590-0018
    • Tokyo-To
      • Setagaya-ku, Tokyo-To, Giappone, 156-0057
  • Lettonia
      • Daugavpils, Lettonia, LV-5417
      • Jelgava, Lettonia, LV-3008
      • Liepaja, Lettonia, LV-3401
      • Riga, Lettonia, LV-1005
      • Strenci, Lettonia, LV-4730
  • Polonia
      • Choroszcz, Polonia, 16-070
      • Gdansk, Polonia, 80-952
      • Gdansk, Polonia, 80-282
      • Lodz, Polonia, 91-229
  • Romania
      • Arad, Romania, 310022
      • Bucuresti, Romania, 010825
      • Bucuresti, Romania, 041914
      • Bucuresti, Romania, 030442
      • Cluj-Napoca, Romania, 400012
      • Focsani, Romania, 620165
      • Pitesti, Romania, 110069
      • Targoviste, Romania, 130086
  • Serbia
      • Belgrade, Serbia, 11000
      • Kragujevac, Serbia, 34000
      • Novi Sad, Serbia, 21000
  • Stati Uniti
    • Arkansas
      • Little Rock, Arkansas, Stati Uniti, 72205
    • California
      • Garden Grove, California, Stati Uniti, 92845
      • Glendale, California, Stati Uniti, 91206
      • Oakland, California, Stati Uniti, 94612
      • Oceanside, California, Stati Uniti, 92056
      • San Diego, California, Stati Uniti, 92123
      • San Diego, California, Stati Uniti, 92102
    • Florida
      • Bradenton, Florida, Stati Uniti, 34208
      • Miami Springs, Florida, Stati Uniti, 33166
      • Orlando, Florida, Stati Uniti, 32806
    • New York
      • Fresh Meadows, New York, Stati Uniti, 11423
      • Jamaica, New York, Stati Uniti, 11432
    • Ohio
      • Dayton, Ohio, Stati Uniti, 45417
    • South Carolina
      • Charleston, South Carolina, Stati Uniti, 29407
      • Charleston, South Carolina, Stati Uniti, 29405
    • Texas
      • Austin, Texas, Stati Uniti, 78754
    • Washington
      • Kirkland, Washington, Stati Uniti, 98033
  • Ucraina
      • Chernihiv, Ucraina, 14000
      • Dnipropetrovsk, Ucraina, 49005
      • Dnipropetrovsk, Ucraina, 49115
      • Glevakha, Ucraina, 08631
      • Kherson, Vil. Stepanivka, Ucraina, 73488
      • Kyiv, Ucraina, 02660
      • Kyiv, Ucraina, 04080
      • Lviv, Ucraina, 79021
      • Simferopol, Ucraina, 95006
      • Vinnytsia, Ucraina, 21005

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

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria
  2. Subjects who have been recently hospitalized or who would benefit from hospitalization for an acute relapse of schizophrenia
  3. Subjects experiencing an acute exacerbation of psychotic symptoms
  4. Other protocol specific inclusion criteria may apply

Exclusion Criteria:

  1. Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug

  2. Subjects with a current DSM-IV-TR Axis I diagnosis of:

    • Schizoaffective disorder
    • Major depressive disorder (MDD)
    • Bipolar disorder
    • Delirium, dementia, amnestic or other cognitive disorder
    • Borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder
  3. Subjects presenting with a first episode of schizophrenia
  4. Other protocol specific exclusion criteria may apply

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: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo
Placebo, una volta al giorno, per sei settimane
Droga: Placebo
Placebo, una volta al giorno, per sei settimane
Sperimentale: OPC-34712 [Brexpiprazole] High Dose
Higher Dose, tablet, once daily, for six weeks
Droga: OPC-34712 [Brexpiprazole] High Dose
Higher dose, tablet, once daily, for six weeks
Sperimentale: OPC-34712 [Brexpiprazole] Middle Dose
Middle Dose, tablet, once daily, for six weeks
Droga: Experimental: OPC-34712 [Brexpiprazole] Middle Dose
Middle dose, tablet, once daily, for six weeks
Sperimentale: OPC-34712 [Brexpiprazole] Low Dose
Lower Dose, tablet, once daily, for six weeks
Droga: Experimental: OPC-34712 [Brexpiprazole] Low Dose
Lower dose, tablet, once daily, for six weeks

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Change From Baseline to Week 6 Positive and Negative Syndrome Scale (PANSS) Total Score.
Lasso di tempo: Baseline to Week 6
The PANSS consists of 3 subscales (positive subscale, negative subscale and general psychology subscale) containing a total of 30 symptom constructs and was administered using the Structured Clinical Interview (SCI)-PANSS. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Baseline to Week 6

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Change From Baseline to Week 6 in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.
Lasso di tempo: Baseline to Week 6
The severity of illness was rated using the CGI-S which is the key secondary endpoint. To perform this assessment, the rater or study physician answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices included: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=among the most extremely ill participant.
Baseline to Week 6
Mean Change From Baseline to Week 1, 2, 3, 4 and 5 Positive and Negative Syndrome Scale (PANSS) Total Score.
Lasso di tempo: Baseline to Week 1, 2, 3, 4, 5
The PANSS consists of 3 subscales (positive subscale, negative subscale and general psychology subscale) containing a total of 30 symptom constructs and was administered using the Structured Clinical Interview (SCI)-PANSS. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Baseline to Week 1, 2, 3, 4, 5
Mean Change From Baseline to Week 1, 2, 3, 4 and 5 in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.
Lasso di tempo: Baseline to Week 1, 2, 3, 4 and 5
The severity of illness was rated using the CGI-S. To perform this assessment, the rater or study physician answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices included: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=among the most extremely ill participant.
Baseline to Week 1, 2, 3, 4 and 5
Mean Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP)
Lasso di tempo: Baseline to Week 6
The PSP is a clinician-rated scale that measures personal and social functioning in 4 domains: socially useful activities (eg, work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater's judgment to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.
Baseline to Week 6
Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score
Lasso di tempo: Baseline to Week 6
For each symptom construct of the PANSS Positive Subscale, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The symptom constructs were as follows: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale Score for each participant was calculated as the sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.
Baseline to Week 6
Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score
Lasso di tempo: Baseline to Week 6
For each symptom construct of the PANSS Negative Subscale, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The symptom constructs were as follows: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale Score for each participant was calculated as the sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.
Baseline to Week 6
Clinical Global Impression- Improvement Scale (CGI-I) Score at Week 6
Lasso di tempo: Week 6
The participant's overall improvement was rated using the CGI-I. The rater or study physician rated the participant's total improvement whether or not it was due entirely to drug treatment. All responses were compared with the participant's condition at screening/baseline. Response choices were: 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse.
Week 6
Response Rate at Week 6
Lasso di tempo: Week 6
Response rate was defined as improvement in mean change of ≥30% from baseline in PANSS Total Score at Week 6 or CGI-I score of 1 (very much improved) or 2 (much improved) at Week 6.
Week 6
Mean Change From Baseline to Week 6 in PANSS Excited Component (PEC) Score
Lasso di tempo: Baseline to Week 6
The PEC consists of 5 PANSS items (excitement [P4], hostility [P7], tension [G4], uncooperativeness [G8], and poor impulse control [G14]). Each rated on a scale of 1 (absent) to 7 (extreme). The PEC for participants was calculated as the sum of the rating assigned to each of the 5 items, and ranged from 5 to 35 with a higher score indicating greater severity of symptoms.
Baseline to Week 6
Discontinuation Rate for Lack of Efficacy at Week 6
Lasso di tempo: Week 6
Week 6
Change From Baseline to Week 6 in PANSS Marder Factor Score - Positive Symptoms Score
Lasso di tempo: Baseline to Week 6
The PANSS Marder Factor score - Positive Symptoms Score consists of 8 PANSS items (delusions [P1], hallucinatory behaviour [P3], grandiosity [P5], suspiciousness [P6], stereotyped thinking [N7], somatic concern [G1], unusual thought content [G9], lack of judgment and insight [G10]. Each was rated on a scale of 1 (absent) to 7 (extreme). The PANSS Marder Factor score - Positive Symptoms Score for participants was calculated as the sum of the rating assigned to each of the 8 items, and ranged from 8 to 42 with a higher score indicating greater severity of symptoms.
Baseline to Week 6
Change From Baseline to Week 6 in PANSS Marder Factor Score - Negative Symptoms Score
Lasso di tempo: Baseline to Week 6
The PANSS Marder Factor score - Negative Symptoms Score consists of 7 PANSS items (blunted effect [N1], emotional withdrawal [N2], poor rapport [N3], passive/apathetic social withdrawal [N4], lack of spontaneity and conversation flow [N6], motor retardation [G7], active social avoidance [G16]). The PANSS Marder Factor score - Negative Symptoms Score for participants was calculated as the sum of the rating assigned to each of the 7 items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.
Baseline to Week 6
Change From Baseline to Week 6 in PANSS Marder Disorganised Thought Score
Lasso di tempo: Baseline to Week 6
The PANSS Marder Factor score -Disorganized Thought Score consists of 7 PANSS items (conceptual disorganization [P2], difficulty in abstract thinking [N5], mannerisms and posturing [G5], disorientation [G10], poor attention [G11], disturbance of violation [G13], preoccupation [G15]). The PANSS Marder Factor score - Disorganized Thought Score for participants was calculated as the sum of the rating assigned to each of the 7 items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.
Baseline to Week 6
Change From Baseline to Week 6 in PANSS Marder Uncontrolled Hostility/Excitement Score
Lasso di tempo: Baseline to Week 6
The PANSS Marder Factor score - Uncontrolled Hostility/Excitement Score consists of 4 PANSS items (excitement [P4], hostility [P7], uncooperativeness [G8], poor impulse control [G14]). The PANSS Marder Factor score - Uncontrolled Hostility/Excitement Score for participants was calculated as the sum of the rating assigned to each of the 4 items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms.
Baseline to Week 6
Change From Baseline to Week 6 in PANSS Marder Anxiety Depression Score
Lasso di tempo: Baseline to Week 6
The PANSS Marder Factor score - Anxiety/Depression Score consists of 4 PANSS items (anxiety [G2], guilt feelings [G3], tension [G4], depression [G6]). The PANSS Marder Factor score - Anxiety/Depression Score for participants was calculated as the sum of the rating assigned to each of the 4 items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms.
Baseline to Week 6

Collaboratori e investigatori

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

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

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 luglio 2011

Completamento primario (Effettivo)

1 gennaio 2014

Completamento dello studio (Effettivo)

1 gennaio 2014

Date di iscrizione allo studio

Primo inviato

11 luglio 2011

Primo inviato che soddisfa i criteri di controllo qualità

15 luglio 2011

Primo Inserito (Stima)

18 luglio 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

29 ottobre 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 settembre 2015

Ultimo verificato

1 settembre 2015

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 331-10-231

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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