Study of the Effectiveness of Three Different Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia (VECTOR)
29. září 2015 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
636
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Kumamoto-shi, Japonsko, 861-8002
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Kanagawa-Ken
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Fujisawa-shi, Kanagawa-Ken, Japonsko, 251-8530
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Okinawa-Ken
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Kunigami-gun, Okinawa-Ken, Japonsko, 904-1201
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Osaka-Fu
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Sakai-shi, Osaka-Fu, Japonsko, 590-0018
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Tokyo-To
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Setagaya-ku, Tokyo-To, Japonsko, 156-0057
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Ontario
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Burlington, Ontario, Kanada, L7R 4E2
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Chatham, Ontario, Kanada, N7M 5L9
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Chatham, Ontario, Kanada, N7L 1B7
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Incheon, Korejská republika, 405-760
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Incheon, Korejská republika, 400-711
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Seoul, Korejská republika, 136-705
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Seoul, Korejská republika, 137-710
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Seoul, Korejská republika, 143-711
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Daugavpils, Lotyšsko, LV-5417
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Jelgava, Lotyšsko, LV-3008
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Liepaja, Lotyšsko, LV-3401
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Riga, Lotyšsko, LV-1005
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Strenci, Lotyšsko, LV-4730
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Choroszcz, Polsko, 16-070
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Gdansk, Polsko, 80-952
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Gdansk, Polsko, 80-282
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Lodz, Polsko, 91-229
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Arad, Rumunsko, 310022
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Bucuresti, Rumunsko, 010825
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Bucuresti, Rumunsko, 041914
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Bucuresti, Rumunsko, 030442
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Cluj-Napoca, Rumunsko, 400012
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Focsani, Rumunsko, 620165
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Pitesti, Rumunsko, 110069
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Targoviste, Rumunsko, 130086
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Arkansas
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Little Rock, Arkansas, Spojené státy, 72205
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California
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Garden Grove, California, Spojené státy, 92845
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Glendale, California, Spojené státy, 91206
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Oakland, California, Spojené státy, 94612
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Oceanside, California, Spojené státy, 92056
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San Diego, California, Spojené státy, 92123
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San Diego, California, Spojené státy, 92102
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Florida
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Bradenton, Florida, Spojené státy, 34208
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Miami Springs, Florida, Spojené státy, 33166
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Orlando, Florida, Spojené státy, 32806
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New York
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Fresh Meadows, New York, Spojené státy, 11423
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Jamaica, New York, Spojené státy, 11432
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Ohio
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Dayton, Ohio, Spojené státy, 45417
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South Carolina
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Charleston, South Carolina, Spojené státy, 29407
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Charleston, South Carolina, Spojené státy, 29405
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Texas
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Austin, Texas, Spojené státy, 78754
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Washington
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Kirkland, Washington, Spojené státy, 98033
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Belgrade, Srbsko, 11000
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Kragujevac, Srbsko, 34000
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Novi Sad, Srbsko, 21000
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Chernihiv, Ukrajina, 14000
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Dnipropetrovsk, Ukrajina, 49005
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Dnipropetrovsk, Ukrajina, 49115
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Glevakha, Ukrajina, 08631
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Kherson, Vil. Stepanivka, Ukrajina, 73488
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Kyiv, Ukrajina, 02660
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Kyiv, Ukrajina, 04080
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Lviv, Ukrajina, 79021
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Simferopol, Ukrajina, 95006
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Vinnytsia, Ukrajina, 21005
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 65 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- 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
- Subjects who have been recently hospitalized or who would benefit from hospitalization for an acute relapse of schizophrenia
- Subjects experiencing an acute exacerbation of psychotic symptoms
- Other protocol specific inclusion criteria may apply
Exclusion Criteria:
- Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug
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
- Subjects presenting with a first episode of schizophrenia
- Other protocol specific exclusion criteria may apply
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Komparátor placeba: Placebo
Placebo, jednou denně, po dobu šesti týdnů
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Placebo, jednou denně, po dobu šesti týdnů
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Experimentální: OPC-34712 [Brexpiprazole] High Dose
Higher Dose, tablet, once daily, for six weeks
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Higher dose, tablet, once daily, for six weeks
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Experimentální: OPC-34712 [Brexpiprazole] Middle Dose
Middle Dose, tablet, once daily, for six weeks
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Middle dose, tablet, once daily, for six weeks
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Experimentální: OPC-34712 [Brexpiprazole] Low Dose
Lower Dose, tablet, once daily, for six weeks
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Lower dose, tablet, once daily, for six weeks
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Mean Change From Baseline to Week 6 Positive and Negative Syndrome Scale (PANSS) Total Score.
Časové okno: Baseline to Week 6
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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).
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Baseline to Week 6
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Mean Change From Baseline to Week 6 in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.
Časové okno: Baseline to Week 6
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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.
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Baseline to Week 6
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Mean Change From Baseline to Week 1, 2, 3, 4 and 5 Positive and Negative Syndrome Scale (PANSS) Total Score.
Časové okno: 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).
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Baseline to Week 1, 2, 3, 4, 5
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Mean Change From Baseline to Week 1, 2, 3, 4 and 5 in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.
Časové okno: 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.
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Baseline to Week 1, 2, 3, 4 and 5
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Mean Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP)
Časové okno: Baseline to Week 6
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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.
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Baseline to Week 6
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Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score
Časové okno: Baseline to Week 6
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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.
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Baseline to Week 6
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Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score
Časové okno: Baseline to Week 6
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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.
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Baseline to Week 6
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Clinical Global Impression- Improvement Scale (CGI-I) Score at Week 6
Časové okno: Week 6
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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.
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Week 6
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Response Rate at Week 6
Časové okno: Week 6
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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.
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Week 6
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Mean Change From Baseline to Week 6 in PANSS Excited Component (PEC) Score
Časové okno: Baseline to Week 6
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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.
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Baseline to Week 6
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Discontinuation Rate for Lack of Efficacy at Week 6
Časové okno: Week 6
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Week 6
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Change From Baseline to Week 6 in PANSS Marder Factor Score - Positive Symptoms Score
Časové okno: Baseline to Week 6
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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.
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Baseline to Week 6
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Change From Baseline to Week 6 in PANSS Marder Factor Score - Negative Symptoms Score
Časové okno: Baseline to Week 6
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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.
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Baseline to Week 6
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Change From Baseline to Week 6 in PANSS Marder Disorganised Thought Score
Časové okno: 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.
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Baseline to Week 6
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Change From Baseline to Week 6 in PANSS Marder Uncontrolled Hostility/Excitement Score
Časové okno: Baseline to Week 6
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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.
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Baseline to Week 6
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Change From Baseline to Week 6 in PANSS Marder Anxiety Depression Score
Časové okno: 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.
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Baseline to Week 6
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Correll CU, He Y, Therrien F, MacKenzie E, Meehan SR, Weiss C, Hefting N, Hobart M. Effects of Brexpiprazole on Functioning in Patients With Schizophrenia: Post Hoc Analysis of Short- and Long-Term Studies. J Clin Psychiatry. 2022 Mar 1;83(2):20m13793. doi: 10.4088/JCP.20m13793.
- Marder SR, Meehan SR, Weiss C, Chen D, Hobart M, Hefting N. Effects of Brexpiprazole Across Symptom Domains in Patients With Schizophrenia: Post Hoc Analysis of Short- and Long-Term Studies. Schizophr Bull Open. 2021 May 1;2(1):sgab014. doi: 10.1093/schizbullopen/sgab014. eCollection 2021 Jan.
- Newcomer JW, Eriksson H, Zhang P, Weiller E, Weiss C. Changes in metabolic parameters and body weight in brexpiprazole-treated patients with acute schizophrenia: pooled analyses of phase 3 clinical studies. Curr Med Res Opin. 2018 Dec;34(12):2197-2205. doi: 10.1080/03007995.2018.1498779. Epub 2018 Jul 27.
- Kane JM, Skuban A, Hobart M, Ouyang J, Weiller E, Weiss C, Correll CU. Overview of short- and long-term tolerability and safety of brexpiprazole in patients with schizophrenia. Schizophr Res. 2016 Jul;174(1-3):93-98. doi: 10.1016/j.schres.2016.04.013. Epub 2016 May 14.
- Correll CU, Skuban A, Ouyang J, Hobart M, Pfister S, McQuade RD, Nyilas M, Carson WH, Sanchez R, Eriksson H. Efficacy and Safety of Brexpiprazole for the Treatment of Acute Schizophrenia: A 6-Week Randomized, Double-Blind, Placebo-Controlled Trial. Am J Psychiatry. 2015 Sep 1;172(9):870-80. doi: 10.1176/appi.ajp.2015.14101275. Epub 2015 Apr 16.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. července 2011
Primární dokončení (Aktuální)
1. ledna 2014
Dokončení studie (Aktuální)
1. ledna 2014
Termíny zápisu do studia
První předloženo
11. července 2011
První předloženo, které splnilo kritéria kontroly kvality
15. července 2011
První zveřejněno (Odhad)
18. července 2011
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
29. října 2015
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
29. září 2015
Naposledy ověřeno
1. září 2015
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 331-10-231
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .