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Phase IIA Study in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00686998
First received: May 28, 2008
Last updated: March 20, 2013
Last verified: March 2013
History of Changes
  Purpose

This study is designed to assess the effects of AZD 2624 in patients with schizophrenia


Condition Intervention Phase
Schizophrenia
 Drug: AZD2624
Drug: Olanzapine
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIa, Double-blind, Double-Dummy, Placebo-controlled, Randomized, Parallel-Group Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of AZD2624 in Adult Schizophrenia Patients

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline [ Time Frame: Baseline, Day 28 ] [ Designated as safety issue: No ]
    PANSS total score, sum of 30 item scores (each on a 0 to 7 scale), assesses positive and negative symptoms of psychopathology on a continuous scale from 0 (the best) to 210 (the worst). Day 28 value was calculated using last observation carried forward (LOCF). Change from baseline was calculated as Day 28 value minus baseline value.


Enrollment: 106
Study Start Date: May 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD2624
AZD2624 40 mg
 Drug: AZD2624
Oral Suspension
Olanzapine
Olanzapine 15 mg
 Drug: Olanzapine
PO BID
Other Name: Zyprexa
Placebo Comparator: Placebo
Matching Placebo
 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females of non-childbearing potential
  • Diagnosis of Schizophrenia

Exclusion Criteria:

  • Clinically relevant disease and /or abnormalities.
  • Alcohol or substance abuse not in remission
  • Enrollment in another investigational study within 30 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00686998

Locations
United States, Maryland
Research Site
Rockville, Maryland, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Dhaval Desai, MD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00686998     History of Changes
Other Study ID Numbers: D0970C00004
Study First Received: May 28, 2008
Results First Received: April 28, 2010
Last Updated: March 20, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by AstraZeneca:
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Olanzapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
 Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on June 18, 2013