Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
第3相
完了
NCT00706654
| 対象疾患 | Schizophrenia |
|---|
| 相 | 第3相 |
|---|
| スポンサー | Otsuka Pharmaceutical Development & Commercialization, Inc. |
|---|
| ステータス | 完了 |
|---|
| 参加者数 | 937 名 |
|---|
| 介入（薬剤） | Aripiprazole depot 300 or 400 mg, Aripiprazole 10-30 mg orally, Aripiprazole depot 25 or 50 mg, Placebo depot, Placebo tablets |
|---|
| 開始日 | 2008年9月1日 |
|---|
| 完了日 | 2012年8月1日 |
|---|
| 結果公開日 | 2013年8月14日 |
|---|
概要
The purpose of the this trial is to evaluate the efficacy, safety, and tolerability of an intramuscular (IM) depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia The trial is designed into three treatment phases. Phase 1 is designed to allow for a subject to be converted from the current anti-psychotic treatment to oral non-generic aripiprazole monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2 the subject will be stabilized on oral non-generic aripiprazole monotherapy. Once the subject is stabilized in Phase 2 (oral stabilization phase from minimum 8 weeks to maximum 28 weeks), they are eligible to be randomized into the double-blind IM depot maintenance phase, Phase 3. During Phase 3, the subject will be assessed for exacerbation of psychotic symptoms and impending relapse for up to 38 weeks.
Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria by the End of Week 26
Baseline to Week 26 · Percentage of patients
| Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase | 7.12 Percentage of patients |
|---|
| Aripiprazole 10-30 mg Orally - Depot Maintenance Phase | 7.76 Percentage of patients |
|---|
| Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase | 21.80 Percentage of patients |
|---|
| p-value | 0.7871 |
|---|
| Mean Difference (Final Values) | -0.64 (95% CI -5.26–3.99) |
|---|
BENITIONS で見る
ClinicalTrials.gov の原文を見る
すべての治験
このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。