Clinical trial NCT00650429: A Study of the Efficacy and Safety of Ziprasidone for the Treatment of Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
Official title: Ziprasidone Intramuscular/Oral In The Treatment Of Acute Exacerbation Of Schizophrenia Or Schizoaffective Disorder: A Six-Week Open Administration Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was conducted to examine the efficacy and tolerability of ziprasidone intramuscular (IM), and to assess the effect of switching from IM to oral ziprasidone for the treatment of acute exacerbation of schizophrenia and schizoaffective disorder in a Latin American population.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder.
* Inpatients with acute exacerbation of psychotic symptoms.
* Patients with a minimum score of 40 on the BPRS scale (1-7).

Exclusion Criteria:

* Concurrent treatment with antipsychotic agents at study drug initiation (within 12 hours prior to study drug initiation); for depot agents a period of two weeks or one cycle, whichever is the longer, must occur between last administration and study drug initiation.
* Treatment with antidepressants or mood stabilizers within 7 days of start of ziprasidone.
* Patients currently receiving clozapine.
* Patients at immediate risk of committing harm to self or others.

Primary outcomes:
measure: Change from baseline to endpoint in Brief Psychiatric Rating Scale (BPRS) total score
timeFrame: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Secondary outcomes:
measure: Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale score
timeFrame: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
measure: Change from baseline to endpoint in Clinical Global Impressions-Improvement (CGI-I) scale score
timeFrame: Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
measure: Simpson-Angus Scale (SAS)
timeFrame: Days 1 and 2 (IM), Day 4 (Switch), and Weeks 2 and 6 (PO)
measure: Barnes Akathisia Scale (BAS)
timeFrame: Days 1 and 2 (IM), Day 4 (Switch), and Weeks 2 and 6 (PO)
measure: Laboratory tests
timeFrame: Screening and Week 6
measure: Electrocardiogram
timeFrame: Screening and Week 6
measure: Adverse events
timeFrame: Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
measure: Abnormal Involuntary Movement Scale (AIMS)
timeFrame: Day 1 (IM), Day 4 (Switch), and Week 6 (PO)
measure: Change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total score
timeFrame: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
measure: Change from baseline to endpoint in Covi Anxiety Scale score
timeFrame: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
measure: Change from baseline to endpoint in Positive PANSS subscale score
timeFrame: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
measure: Change from baseline to endpoint in Negative PANSS subscale score
timeFrame: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo LEON
city: DF
country: Mexico
facility: Pfizer Investigational Site
city: Mexico City
country: Mexico
facility: Pfizer Investigational Site
city: Mexico D F
country: Mexico
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: