Trial Evaluating the Safety and Efficacy of 2 Doses of ER OROS Paliperidone in Acute Adult Schizophrenics - Article Lodine XL
Clinical Trial: Trial Evaluating the Safety and Efficacy of 2 Doses of ER OROS Paliperidone in Acute Adult Schizophrenics
This study has been completed.
|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
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
- 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.
J. Gary Booker, MD, Shreveport, Louisiana, 71101, United States
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
Cache Date: April 9, 2005