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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. September 2015 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

636

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Placebo
Placebo, einmal täglich, sechs Wochen lang
Arzneimittel: Placebo
Placebo, einmal täglich, sechs Wochen lang
Experimental: OPC-34712 [Brexpiprazole] High Dose
Higher Dose, tablet, once daily, for six weeks
Arzneimittel: OPC-34712 [Brexpiprazole] High Dose
Higher dose, tablet, once daily, for six weeks
Experimental: OPC-34712 [Brexpiprazole] Middle Dose
Middle Dose, tablet, once daily, for six weeks
Arzneimittel: Experimental: OPC-34712 [Brexpiprazole] Middle Dose
Middle dose, tablet, once daily, for six weeks
Experimental: OPC-34712 [Brexpiprazole] Low Dose
Lower Dose, tablet, once daily, for six weeks
Arzneimittel: Experimental: OPC-34712 [Brexpiprazole] Low Dose
Lower dose, tablet, once daily, for six weeks

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mean Change From Baseline to Week 6 Positive and Negative Syndrome Scale (PANSS) Total Score.
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mean Change From Baseline to Week 6 in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Week 6
Week 6
Change From Baseline to Week 6 in PANSS Marder Factor Score - Positive Symptoms Score
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juli 2011

Primärer Abschluss (Tatsächlich)

1. Januar 2014

Studienabschluss (Tatsächlich)

1. Januar 2014

Studienanmeldedaten

Zuerst eingereicht

11. Juli 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

15. Juli 2011

Zuerst gepostet (Schätzen)

18. Juli 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

29. Oktober 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. September 2015

Zuletzt verifiziert

1. September 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 331-10-231

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