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Completed

NCT Number: NCT00265551

Study Evaluating SCA-136 in Subjects With Acute Exacerbations of Schizophrenia

The purpose of this study is to determine whether a low dose and a high dose of the study drug SCA-136 are effective and safe in the treatment of schizophrenia requiring hospitalization.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of schizophrenia
  • Ability to remain hospitalized for at least first 4 weeks of study
  • Needs hospitalization due to worsening of schizophrenia

Exclusion criteria

  • Type 1 or 2 diabetes
  • Previous use of clozapine
  • Serious medical illness other than schizophrenia

Treatment and study plan

SCA-136 (200 mg)

Drug

SCA-136 (400 mg)

Drug

olanzapine (15 mg)

Drug

Placebo

Drug

Primary outcomes

  1. Change from baseline to day 42 on the positive subscale of the SCI-PANNS

Secondary outcomes

  1. Change from baseline to day 42 on:

  2. SCI-PANNS total score

  3. negative symptom sub-scale score of SCI-PANNS

  4. general psychopathology subscale score of SCI-PANNS

  5. response rate based upon SCI-PANNS total score

  6. BPRS score

  7. CGI-S score

  8. CGI-I score

  9. Cognitive assessments scores

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Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Olanzapine-Referenced, Parallel Group Safety, Efficacy, and Tolerability Study of SCA-136 in Subjects With Acute Exacerbations of Schizophrenia

Important dates

Study start
2006
Study completion
2007
First posted
Dec 14, 2005
Registry last updated
Dec 10, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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