Schizophrenia Clinical Trial
— PAFIP2Official title:
Phase IV Study of the Effectiveness of Aripiprazole, Quetiapine, and Ziprasidone in the Treatment of First Episode of Non-affective Psychosis Individuals Included in the First Episode Psychosis Clinical Program II (PAFIP II)
Verified date | March 2017 |
Source | Fundación Marques de Valdecilla |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The selection of antipsychotic in early stages of the illness is mainly determined by its clinical effectiveness. Second generation antipsychotics (SGAs) are the first line drug treatment for individuals suffering from schizophrenia. It is clear that SGAs are not a homogeneous group and clinical effects and profile of side effects differ between SGAs. Differences among antipsychotics in terms of effectiveness have turned out to be a topic of increasing research interest, although comparisons between the different SGAs are scarce. In first episode of psychosis, SGAs have shown a higher treatment effectiveness compared to first generation antipsychotics (FGAs) (findings primarily driven by Haloperidol). Less evident seems to be the notion that some of the SGAs might be more effective (in terms of treatment discontinuation) than others. Most of the medium-term randomized studies have shown similar rates of all-cause treatment discontinuation in first episode patients treated with different SGAs. It may be concluded that more randomized controlled trails should be accomplished to determine the position of frequently used SGAs in clinical practice. The investigators undertook this study with the major objective of comparing the clinical effectiveness of three widely utilized SGAs (Aripiprazole, Ziprasidone and Quetiapine) in the acute treatment of first-episode non-affective psychosis individuals.
Status | Completed |
Enrollment | 203 |
Est. completion date | May 2014 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 15 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 15-60 years. - Living in the catchment area. - Experiencing their first episode of psychosis. - No prior treatment with antipsychotic medication or, if previously treated, a total life time of adequate antipsychotic treatment of less than 6 weeks. - Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for brief psychotic disorder, schizophreniform disorder, schizophrenia, or schizoaffective disorder. Exclusion Criteria: - Meeting DSM-IV criteria for drug dependence - Meeting DSM-IV criteria for mental retardation - Having a history of neurological disease or head injury. |
Country | Name | City | State |
---|---|---|---|
Spain | University Hospital Marques de Valdecilla | Santander | Cantabria |
Lead Sponsor | Collaborator |
---|---|
Fundación Marques de Valdecilla | Centro de Investigación Biomédica en Red de Salud Mental, Instituto de Investigación Marqués de Valdecilla |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Relapse rate | 1 year | ||
Primary | Effectiveness of antipsychotics (percentage of discontinuation of the initially assigned treatment) | The main outcomes of effectiveness were the percentage of discontinuation of the initially assigned treatment (patients who completed the 6 weeks follow-up assessment and changed initial antipsychotic) and the mean time to all-cause medication discontinuation. Four reasons for the discontinuation were recorded: 1.- insufficient efficacy; 2.- marked side-effects; 3.- patient reported non-adherence and 4.- other causes. If more than one reason for discontinuation was present, the most important reason according to the above ranking was selected. Data on antipsychotic treatment (doses, discontinuation and concomitant medications) were registered weekly during the first 4 weeks and at 6 week. Insufficient efficacy was established at the treating physician´s judgment only after at least three weeks of treatment. | 6 weeks | |
Secondary | Change in general psychopathology measured by the Brief Psychiatric Rating Scale (BPRS) | Measured by BPRS. The patients were defined as responders to the optimum dose of antipsychotic at 6 weeks if a >40% reduction of the BPRS scores at intake and had a CGI severity score of = 4. In addition, we also explored to rate of responders if a cutoff of = 50% reduction of the BPRS total scores at intake was used. | 6 weeks, 3 months and 1 year | |
Secondary | Change in positive and negative symptoms measured by the Scale for the Assessment of Negative and Positive Symptoms (SANS and SAPS) | Measured by SANS and SAPS. | 6 weeks, 3 months and 1 year | |
Secondary | Change in the severity of depressive symptoms measured by the Calgary Depression Scale (CDS) | Measured by CDS. | 6 weeks, 3 months and 1 year | |
Secondary | Change in maniac symptoms measured by the Young Mania Rating Scale (YMRS) | Measured by YMRS. | 6 weeks, 3 months and 1 year | |
Secondary | Adherence to treatment | 1 year |
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