Clinical trial NCT01393613: Efficacy Study of OPC-34712 in Adults With Acute Schizophrenia
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Fixed-dose OPC-34712 in the Treatment of Adults With Acute Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Schizophrenia
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2011-07-13
Enrollment: 674
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy, safety, and tolerability of fixed doses of OPC-34712 versus placebo for the treatment of adult subjects with an acute relapse of schizophrenia.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by 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
   * 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

Primary outcomes:
measure: Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score.
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5, and 6
Secondary outcomes:
measure: Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity (CGI-S) Score.
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5, and 6
measure: Mean Change From Baseline to Week 6 in Personal and Social Performance (PSP) Score.
timeFrame: Baseline, Week 3 and Week 6
measure: Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score.
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5, and 6
measure: Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score.
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5, and 6
measure: Mean Clinical Global Impression-Improvement (CGI-I) Scale Score at Week 6.
timeFrame: Week 6
measure: Percentage of Participants With Response at Week 6.
timeFrame: Week 6
measure: Percentage of Participants With Discontinuation Rate for Lack of Efficacy at Week 6.
timeFrame: Week 6
measure: Mean Change From Baseline to Week 6 in PANSS Excited Component (PEC) Score.
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5, and 6
measure: Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Positive Symptoms Score.
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5, and 6
measure: Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Negative Symptoms Score.
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5, and 6
measure: Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Disorganized Thought Score.
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5, and 6
measure: Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Uncontrolled Hostility and Excitement Score.
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5, and 6
measure: Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Anxiety and Depression Score.
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5, and 6
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Springdale
country: United States
state: Arkansas
city: Escondido
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Orange
country: United States
state: California
city: Pico Rivera
country: United States
state: California
city: San Diego
country: United States
state: California
city: North Miami
country: United States
state: Florida
city: North Miami
country: United States
state: Florida
city: Overland Park
country: United States
state: Kansas
city: Lake Charles
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Flowood
country: United States
state: Mississippi
city: St. Louis
country: United States
state: Missouri
city: Buffalo
country: United States
state: New York
city: Memphis
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Bogota
country: Colombia
city: Medellin
country: Colombia
city: Pereira
country: Colombia
city: Rijeka
country: Croatia
city: Zagreb
country: Croatia
city: Zagreb
country: Croatia
city: Col. Florida
country: Mexico
state: Distrito Federal
city: Mexico
country: Mexico
state: Distrito Federal
city: Monterrey
country: Mexico
state: Nuevo Leon
city: San Luis Potosi
country: Mexico
state: San Luis Potos
city: Monterrey
country: Mexico
city: Cebu City
country: Philippines
city: Davano City
country: Philippines
city: Makati City
country: Philippines
city: Mandaluyong City
country: Philippines
city: Manila
country: Philippines
city: Arkhangelsk
country: Russian Federation
city: Moscow Region
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhniy Novgorod
country: Russian Federation
city: Petrozavodsk
country: Russian Federation
city: Samara
country: Russian Federation
city: Saratov
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Village Nikolskoe
country: Russian Federation
city: Bojnice
country: Slovakia
city: Bratislava
country: Slovakia
city: Michalovace
country: Slovakia
city: Rimavska Sobota
country: Slovakia
city: Roznava
country: Slovakia
city: Kaohsiung
country: Taiwan
city: New Taipei City
country: Taiwan
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
Study officials:
affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc.
name: Aleksandar Skuban, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Kane JM, Skuban A, Ouyang J, Hobart M, Pfister S, McQuade RD, Nyilas M, Carson WH, Sanchez R, Eriksson H. A multicenter, randomized, double-blind, controlled phase 3 trial of fixed-dose brexpiprazole for the treatment of adults with acute schizophrenia. Schizophr Res. 2015 May;164(1-3):127-35. doi: 10.1016/j.schres.2015.01.038. Epub 2015 Feb 12.