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A 28-week, Randomised, Open-label Study Evaluating the Effectiveness of Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With Schizophrenia
To assess the effectiveness of aripiprazole once-monthly in the maintenance treatment of patients with a diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR®), in a naturalistic care setting by comparing it to an existing long-acting antipsychotic, paliperidone palmitate.
Details
| Lead sponsor | H. Lundbeck A/S |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 295 |
| Start date | 2013-02 |
| Completion | 2014-09 |
Conditions
- Schizophrenia
Interventions
- Aripiprazole and aripiprazole once-monthly
- Paliperidone and paliperidone palmitate
Primary outcomes
- Change From Baseline to Week 28 in Quality of Life Scale (QLS) Total Score — Baseline, Week 28
The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). Definitions were provided for 4 anchor points of the 7 points. Each item had a brief description of the judgement to be made and a set of suggested probes for the clinician. The total score was calculated as the sum of all 21 items giving a range of 0 to 126, where the higher score indicated normal or unimpaired functioning.
Countries
United States