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OpenTrials
Completed

NCT Number: NCT00325689

Aripiprazole Used as Dual Therapy in the Treatement of Patients With Chronic Stable Schizophrenia or Schizoaffective Disorder.

A Multicenter, Double-blind 16 Week Study on the augmentation of atypical antipsychotic with Aripiprazole in patients with Schizophrenia with inadequate response to antipsychotic treatment.

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

K & S Professional Research Services, Llc, 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

  • Patient with diagnosis of chronic Schizophrenia or Schizoaffective disorder
  • Stable symptoms and dose of Quetiapine or Risperidone

Exclusion criteria

  • First diagnosis in the past year
  • Significant risk of suicide or meet DSM-IV-TR criteria for substance abuse

Treatment and study plan

Quetiapine or Risperidone + Aripiprazole

Drug

Tablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Aripiprazole 2-15 mg/day, Flexible, 16 weeks.

Other names: Abilify

Quetiapine or Risperidone + placebo

Drug

Tablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Placebo, Flexible, 16 weeks.

Primary outcomes

  1. Evaluate the efficacy of adding Aripiprazole to atypical antipsychotic treatment via Positive and Negative Symptoms Scale (PANSS) score at endpoint

    Time frame: (Week 16) or at time of discontinuation

Secondary outcomes

  1. Assess efficacy according to changes in the severity of illness symptoms as measured by the Clinical Global Impressions-Severity (CGI-S)

    Time frame: at endpoint (Week 16)

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Collaborators

  • Otsuka America Pharmaceutical

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Placebo-controlled, 16 Week Study of Aripiprazole Used as Dual Therapy in the Treatment of Patients With Chronic Stable Schizophrenia or Schizoaffective Disorder Demonstrating an Inadequate Response to Quetiapine or Risperidone Monotherapy.

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 15, 2006
Registry last updated
Nov 8, 2013

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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