Aripiprazole in the Treatment of Acutely Relapsed Patients With Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy, safety and tolerability of aripiprazole in the treatment of acutely
      relapsed patients with diagnoses of schizophrenia or schizoaffective disorder with
      risperidone as an active control.
    

Detailed description: 
      Medical treatment of schizophrenia uses antipsychotic drugs, which ameliorate the acute
      episodes and probably prevent or decrease the risk of occurrence of new episodes. Most
      antipsychotics share the ability to block postsynaptic dopaminergic receptors of the D2
      subtype.

      The typical antipsychotics (such as haloperidol and chlorpromazine) ameliorate acute episodes
      and possibly prevent or decrease the risk of occurrence of new episodes, but they have
      minimal effectiveness against negative symptoms, mood symptoms, and cognitive impairment,
      which often lead to poor social functioning. Its full Dopamine antagonism is often associated
      with a number of well-recognized debilitating side effects. One example is EPS. A new class
      of antipsychotics, the atypical agents (such as clozapine, risperidone, olanzapine), became
      available starting in the late-1980s. Their mode of action affects both the serotonin and
      dopamine (DA) receptors. They are better tolerated than the typical antipsychotics with
      regard to EPS, except at higher doses. The improvement in the side effect profile seen with
      the atypical antipsychotics is accompanied by efficacy against positive symptoms and perhaps
      some improvement in efficacy against negative symptoms. Although they offer better efficacy
      and lower rates of EPS compared to typical agents, they are associated with other side
      effects that may be of clinical concern. For example, olanzapine and clozapine have an
      increased incidence of weight gain and diabetes mellitus, risperidone is associated with
      hyperprolactinemia, and ziprasidone is associated with ECG QT interval prolongation. In
      addition to tolerability issues, a significant proportion of patients still do not adequately
      respond to these newer agents. A need still exists for efficacious alternatives that
      demonstrate improved tolerability and side effect profiles so as to enhance treatment
      compliance and long-term functioning.

      Aripiprazole is a novel DA-serotonin stabilizer approved in U.S. for the management of
      schizophrenia. The unique mode of action of aripiprazole translates into efficacy against
      psychotic symptoms and a more favorable safety profile than current treatment. Its
      introduction will clearly provide patients and their families with a much-needed alternative
      to the antipsychotics currently available.

      This study further examined the efficacy and safety of aripiprazole in patients having acute
      relapse of schizophrenia or schizoaffective disorder in Taiwan. The duration of this study
      was 4 weeks.
    

Intervention name(s): Aripiprazole; Risperidone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Risperidone; Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Aripiprazole; Risperidone; Schizophrenia; Schizoaffective disorder