Aripiprazole in the Treatment of Acutely Relapsed Patients With Schizophrenia
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of Aripiprazole in the Treatment of Acutely Relapsed Patients With Schizophrenia or Schizoaffective Disorder With Risperidone as an Active Control|
- PANSS-total score
- PANSS-positive score, PANSS-negative score, CGI-severity score, CGI-improvement score, and safety/tolerability.
|Study Start Date:||March 2004|
|Study Completion Date:||December 2004|
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.
|National Taiwan University Hospital|
|Taipei, Taiwan, 100|
|Principal Investigator:||Tzung-Jeng Hwang, M.D., M.P.H.||National Taiwan University Hospital|
|Principal Investigator:||Hung-Yu Chan, M.D.||Taoyuan Mental Hospital|
|Principal Investigator:||Wei-Wen Lin, M.D., Ph.D.||Tri-Service General Hospital|
|Principal Investigator:||Shih-Ku Lin, M.D.||Taipei City Psychiatric Center|
|Principal Investigator:||Tung-Ping T. Su, M.D.||Taipei Veterans General Hospital, Taiwan|
|Principal Investigator:||Hai-Gwo Hwu, M.D.||National Taiwan University Hospital|