Clinical trial NCT01396421: Study of the Effectiveness of Three Different Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Schizophrenia
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2011-07-18
Enrollment: 636
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 compare the effectiveness, safety and tolerability of three different doses of OPC-34712 with placebo in the treatment of acute schizophrenia in adults.

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 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

Primary outcomes:
measure: Mean Change From Baseline to Week 6 Positive and Negative Syndrome Scale (PANSS) Total Score.
timeFrame: Baseline to Week 6
Secondary outcomes:
measure: Mean Change From Baseline to Week 6 in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.
timeFrame: Baseline to Week 6
measure: Mean Change From Baseline to Week 1, 2, 3, 4 and 5 Positive and Negative Syndrome Scale (PANSS) Total Score.
timeFrame: Baseline to Week 1, 2, 3, 4, 5
measure: Mean Change From Baseline to Week 1, 2, 3, 4 and 5 in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.
timeFrame: Baseline to Week 1, 2, 3, 4 and 5
measure: Mean Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP)
timeFrame: Baseline to Week 6
measure: Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score
timeFrame: Baseline to Week 6
measure: Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score
timeFrame: Baseline to Week 6
measure: Clinical Global Impression- Improvement Scale (CGI-I) Score at Week 6
timeFrame: Week 6
measure: Response Rate at Week 6
timeFrame: Week 6
measure: Mean Change From Baseline to Week 6 in PANSS Excited Component (PEC) Score
timeFrame: Baseline to Week 6
measure: Discontinuation Rate for Lack of Efficacy at Week 6
timeFrame: Week 6
measure: Change From Baseline to Week 6 in PANSS Marder Factor Score - Positive Symptoms Score
timeFrame: Baseline to Week 6
measure: Change From Baseline to Week 6 in PANSS Marder Factor Score - Negative Symptoms Score
timeFrame: Baseline to Week 6
measure: Change From Baseline to Week 6 in PANSS Marder Disorganised Thought Score
timeFrame: Baseline to Week 6
measure: Change From Baseline to Week 6 in PANSS Marder Uncontrolled Hostility/Excitement Score
timeFrame: Baseline to Week 6
measure: Change From Baseline to Week 6 in PANSS Marder Anxiety Depression Score
timeFrame: Baseline to Week 6
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Garden Grove
country: United States
state: California
city: Glendale
country: United States
state: California
city: Oakland
country: United States
state: California
city: Oceanside
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Bradenton
country: United States
state: Florida
city: Miami Springs
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Fresh Meadows
country: United States
state: New York
city: Jamaica
country: United States
state: New York
city: Dayton
country: United States
state: Ohio
city: Charleston
country: United States
state: South Carolina
city: Charleston
country: United States
state: South Carolina
city: Austin
country: United States
state: Texas
city: Kirkland
country: United States
state: Washington
city: Burlington
country: Canada
state: Ontario
city: Chatham
country: Canada
state: Ontario
city: Chatham
country: Canada
state: Ontario
city: Fujisawa-shi
country: Japan
state: Kanagawa-Ken
city: Kunigami-gun
country: Japan
state: Okinawa-Ken
city: Sakai-shi
country: Japan
state: Osaka-Fu
city: Setagaya-ku
country: Japan
state: Tokyo-To
city: Kumamoto-shi
country: Japan
city: Incheon
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Daugavpils
country: Latvia
city: Jelgava
country: Latvia
city: Liepaja
country: Latvia
city: Riga
country: Latvia
city: Strenci
country: Latvia
city: Choroszcz
country: Poland
city: Gdansk
country: Poland
city: Gdansk
country: Poland
city: Lodz
country: Poland
city: Arad
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Cluj-Napoca
country: Romania
city: Focsani
country: Romania
city: Pitesti
country: Romania
city: Targoviste
country: Romania
city: Belgrade
country: Serbia
city: Kragujevac
country: Serbia
city: Novi Sad
country: Serbia
city: Chernihiv
country: Ukraine
city: Dnipropetrovsk
country: Ukraine
city: Dnipropetrovsk
country: Ukraine
city: Glevakha
country: Ukraine
city: Kherson, Vil. Stepanivka
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Lviv
country: Ukraine
city: Simferopol
country: Ukraine
city: Vinnytsia
country: Ukraine
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: 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.