A Study of the Efficacy and Safety of Intramuscular Ziprasidone Followed by Oral Ziprasidone for the Treatment of Psychosis

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy, safety, and tolerability of intramuscular ziprasidone in the treatment of the acute exacerbation of non-organic psychosis of any etiology, including schizophrenia, acute mania, delusional disorder and others.

Official Title
-----------------
An Open, Multicenter, Non-Comparative Study To Assess The Efficacy And Tolerability Of Intramuscular Ziprasidone Followed By Oral Ziprasidone In Patients With Acute Psychosis

Conditions
-----------------
Schizophrenia, Mania, Delusional Disorder, Acute Exacerbation of Psychosis

Intervention / Treatment
-----------------
* Drug: Ziprasidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized patients with psychosis Eligible for intramuscular treatment Miminum score of 60 on the PANSS, a score of 14 in the sum of PANSS excitation score and a score of at least 4 in 1 of the following items: poor control of impulses, tension, hostility, uncooperativeness or excitation. Exclusion Criteria: Treatment with antidepressants or mood stabilizers within seven days prior to the enrollment; for monoamine oxidase inhibitors (MAOIs) and moclobemide, this period must be two weeks; for fluoxetine, five weeks Resistance to conventional antipsychotic agents A history of epilepsy A diagnosis of abuse of substance within the previous 3 months according to the DSMIV criteria.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br> | Drug: Ziprasidone<br>* Intramuscular ziprasidone 10 or 20 mg at the investigator's discretion for 1 to 3 days followed by oral ziprasidone capsules 40 to 80 mg twice daily at the investigator's discretion to complete 7 days of treatment<br>* Other names: Geodon, Zeldox;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Positive and Negative Syndrome Scale (PANSS) excitation items scores |  | Days 1-3 (end of intramuscular dosing) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrocardiogram at Visits 1 and 5 |  | Visits 1 (Screening) and 5 (Day 7) | 
| Adverse events at Visits 2, 3, 4, and 5 |  | Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7) | 
| Change from baseline in Patient Preference Scale (PPS) scores at Visits 3 and 5 |  | Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4) and 5 (Day 7) | 
| Laboratory tests at Visits 1 and 5 |  | Visits 1 (Screening) and 5 (Day 7) | 
| Movement disorder rating scale scores (Barnes Akathisia Scale and Extrapyramidal Symptoms Rating Scale) at Visits 2, 3, 4, and 5 |  | Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7) | 
| Change from baseline in PANSS excitation items scores at Visits 3, 4, and 5 |  | Visits 1 (Screening), 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7) | 
| Blood pressure and pulse at Visits 1, 2, and 5 |  | Visits 1 (Screening), 2 (Day 1), and 5 (Day 7) | 
| Change from baseline in Clinical Global Impression-Severity (CGI-S) scores at Visits 3, 4, and 5 |  | Visits 1 (Screening), 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7) |