Pseudoephedrine and Guaifenesin ER |
Aquatab D; Coldmist JR; Coldmist LA; Defen LA; Durasal II; Entex PSE; Guaifen-PD; Miraphen PSE; PanMist JR; PanMist LA; Profen Forte; Profen II; Pseudovent; Respaire-120; Respaire-60; Sudal; Versacaps; Zephrex LA |
Clinical Trial: Trial Evaluating the Safety and Efficacy of 2 Doses of ER OROS Paliperidone in Acute Adult Schizophrenics
This study has been completed.
|
Purpose
The purpose of this trial is to determine if ER OROS Paliperidone is an effective treatment for adults with acute schizophrenia.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Schizophrenia | Drug: ER OROS Paliperidone | Phase III |
MedlinePlus related topics: Schizophrenia
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Expected Total Enrollment: 440
Study start: February 2004; Study completion: November 2004
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
- Age must be 18 years of age or older.
- Subjects must have been diagnosed with schizophrenia according to DSM-IV (295.10, 295.20, 295.30, 295.60, 295.90) at least 1 year prior to screening.
- Subjects must be experiencing an acute episode, with a total PANSS score at screening between 70 and 120.
- Subjects must agree to voluntary hospitalization for a minimum of 14 days.
Location Information
Louisiana
J. Gary Booker, MD, Shreveport, Louisiana, 71101, United States
More Information
Record last reviewed: November 2004
Last Updated: November 19, 2004
Record first received: February 11, 2004
ClinicalTrials.gov Identifier: NCT00077714
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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