Non-Interventional Study of Ziprasidone in the Treatment of Bipolar and Schizoaffective Disorders.
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00454883
First received: March 29, 2007
Last updated: November 18, 2008
Last verified: November 2008
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Purpose
Assessment of ziprasidone safety and efficacy in the treatment of bipolar and schizoaffective disorders.
| Condition | Intervention | Phase |
|---|---|---|
|
Affective Psychosis, Bipolar Mania Manic-Depressive Psychosis |
Drug: ziprasidone |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Treatment Of Manic Or Mixed Episodes Of Up To Moderate Severity In Patients With Bipolar Disorder And Schizoaffective Disorder |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Clinical global impression [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Recording of extrapyramidal symptoms [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Changes in manic symptoms over course of treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Severity of disease [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Adverse Events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 379 |
| Study Start Date: | April 2007 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 1 cohort of patients treated with ziprasidone |
Drug: ziprasidone
Ziprasidone 40 mg twice daily taken with food. Daily dosage may subsequently be adjusted on the basis of individual clinical status up to a maximum of 80 mg twice daily. If indicated, the maximum recommended dose may be reached as early as day 3 of treatment.
Other Name: Geodon, Zeldox
|
Detailed Description:
Method: Consecutive patient sampling. Patients were included in the study in consecutive manner if they fulfilled the inclusion criteria and any of the exclusion criteria were not present.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
The patients were identified in in- and outpatients settings (university departments, hospital wards, outpatients clinics, daily psychiatric hospitals)
Criteria
Inclusion Criteria:
- Manic and mixed episodes of up to moderate severity in patients with Type I and II bipolar disorder and schizoaffective disorder; either first diagnosed or repeated episodes
Exclusion Criteria:
- Hypersensitivity to ziprasidone
- prolonged QTc interval
- coadministration with substances that are prolonging the QTc interval
- recent acute MI, cardiac failure, patients with arrhythmias treated with class IA or III medicaments
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer Inc |
| ClinicalTrials.gov Identifier: | NCT00454883 History of Changes |
| Other Study ID Numbers: | A1281159 |
| Study First Received: | March 29, 2007 |
| Last Updated: | November 18, 2008 |
| Health Authority: | Slovakia: State Institute for Drug Control |
Keywords provided by Pfizer:
|
Safety of ziprasidone, efficacy of ziprasidone, manic episodes in bipolar disorder, mixed episodes in bipolar disorder, schizoaffective disorder. |
Additional relevant MeSH terms:
|
Affective Disorders, Psychotic Bipolar Disorder Mental Disorders Psychotic Disorders Depressive Disorder, Major Mood Disorders Schizophrenia and Disorders with Psychotic Features Depressive Disorder Ziprasidone Serotonin Antagonists Serotonin Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on May 23, 2013