Schizophrenia MedDRA version: 16.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Abilify
Pharmaceutical Form: Tablet
INN or Proposed INN: ARIPIPRAZOLE
CAS Number: 129722-12-9
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg milligram(s)
Concen
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient has schizophrenia, diagnosed according to DSM-IV-TR®. 2. The patient has a CGI-S score from mildly ill to markedly ill at the Screening and Baseline Visit(s). 3. The patient is in need of a change in the current antipsychotic treatment and in the judgement of the investigator the patient would benefit from an extended treatment with a once-monthly formulation. 4. The patient agrees to protocol-defined use of effective contraception. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 286 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. The patient has any current psychiatric disorder or Axis I disorder (DSMIV ® criteria) other than schizophrenia established as the primary diagnosis. 2. The patient is experiencing acute exacerbation of psychotic symptoms at the Screening Visit or between the Screening and Baseline Visits. 3. The patient in the investigator's judgment has shown significant intolerance and/or lack of efficacy to oral aripiprazole, paliperidone or risperidone. 4. The patient is at significant risk of harming himself/herself or others according to the investigator's judgement or according to Columbia-Suicide Severity Rating Scale (C-SSRS). 5. The patient has a history of neuroleptic malignant syndrome. The patient has any relevant medical history or current presence of systemic disease 6. The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Effectiveness of aripiprazole once-monthly in the maintenance treatment of patients with a diagnosis of schizophrenia;Secondary Objective: Effectiveness of aripiprazole once-monthly versus paliperidone palmitate;Primary end point(s): Mean change from Baseline in quality of life;Timepoint(s) of evaluation of this end point: Baseline and Week 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Investigator's assessment of overall effectiveness 2. Mean change from Baseline in clinical global impression 3. Mean change from Baseline in quality of life using QLS 4. Mean change from Baseline in subjective well-being using SWN-S 5. Mean change from Baseline in tolerability and quality of life using TooL 6. Safety and tolerability 7. Risk of suicidality;Timepoint(s) of evaluation of this end point: 1. Week 28 2. Baseline and Week 28 3. Baseline and Week 28 4. Baseline and Week 28 5. Baseline and Week 28 6. Up to 28 weeks and 4-week safety follow up 7. Up to 28 weeks and 4-week safety follow up | — |
Countries
Canada, Czech Republic, Estonia, France, Germany, Italy, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactLundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
Outcome results
None listed