Quetiapine Extended Release Depression Symptoms - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00640562

Purpose

Aim of the study is to assess if the new compound Seroquel XR™ is non-inferior to Risperidone, considered as the reference drug for the treatment of depressive symptoms of schizophrenia.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Condition	Intervention	Phase
Schizophrenia Depression	Drug: Quetiapine Extended Release Drug: Risperidone	Phase III

MedlinePlus related topics: Depression Schizophrenia

Drug Information available for: Risperidone Quetiapine Quetiapine fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Comparison of Quetiapine Extended-Release (Seroquel XR™) and Risperidone Int he Treatment of Depressive Symptoms, in Schizophrenic or Schizoaffective Patients: A Randomized, Open Label, Flexible-Dose, Parallel Group, Non Inferiority, 12-Week Study

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To evaluate the efficacy of Seroquel XR™ versus Risperidone on depressive symptoms assess with Calgary Depression Scale of Schizophrenia (CDSS: Addington D etal 1990), in schizophrenic or schizoaffective patients [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the efficacy of Seroquel XR™ versus Risperidone on depressive symptoms in schizophrenic or schizoaffective patients, assessed with Hamilton Rating Scale for Depression (HAM-D; Hamilton M 1960) [ Designated as safety issue: No ]
To evaluate efficacy of Seroquel XR™ vs. Risperidone on negative and positive symptoms, in schizophrenic and schizoaffective patients, assess with positive and negative Syndrome Scale (PANSS; Kay SR et al 1978) [ Designated as safety issue: No ]
To evaluate efficacy of Seroquel XR™ vs. Risperidone on attitude towards treatment in schizophrenic or schizoaffective patients, assess with Drug Attitude Inventory (DAI-10; Hogan TO et al, 1983) [ Designated as safety issue: No ]

Estimated Enrollment:	290
Study Start Date:	February 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Quetiapine Extended Release
2: Active Comparator	Drug: Risperidone

Eligibility

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

Criteria

Inclusion Criteria:

Provision of written informed consent
Patients who satisfy the criteria for diagnosis of schizophrenia or schizoaffective disorder according to DSM-IVTR
Baseline depressive symptoms, assessed by means of HAM-D (21-item) score ≥20, and HAM-D item 1 score ≥2

Exclusion Criteria:

Any DSM-IV Axis I disorder other than schizophrenia and schizoaffective disorder
Patients treated with depot antipsychotic medications within 1 dosing interval before day 0; patients treated with other AP oral medications during the trial except for the switch period
Use of Clozapine within 28 days prior to enrollment or Clozapine non responders
Any significant clinical disorder that, in the opinion of the investigator, made the subject unsuitable to be given treatment with an investigational drug
An absolute neutrophil count (ANC) of ≤1.5 x 109 per liter
Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640562

Contacts

Contact: AstraZeneca Basiglio Clinical Study Inforamtion

02-9801-59831

Locations

Italy
Research Site	Not yet recruiting
FRATTAMINORE, Italy
Research Site	Recruiting
ROMA, Italy
Italy, AO
Research Site	Not yet recruiting
AOSTA, AO, Italy
Italy, AP
Research Site	Recruiting
FERMO, AP, Italy
Italy, BG
Research Site	Recruiting
BERGAMO, BG, Italy
Italy, BR
Research Site	Recruiting
BRINDISI, BR, Italy
Italy, BS
Research Site	Recruiting
LENO, BS, Italy
Italy, CA
Research Site	Recruiting
CARBONIA, CA, Italy
Italy, CB
Research Site	Recruiting
TERMOLI, CB, Italy
Italy, CT
Research Site	Recruiting
CATANIA, CT, Italy
Italy, EN
Research Site	Recruiting
NICOSIA, EN, Italy
Italy, FG
Research Site	Not yet recruiting
LUCERA, FG, Italy
Italy, LU
Research Site	Recruiting
LIDO DI CAMAIORE, LU, Italy
Italy, ME
Research Site	Recruiting
MESSINA, ME, Italy
Research Site	Recruiting
MILAZZO, ME, Italy
Italy, SA
Research Site	Not yet recruiting
NOCERA INFERIORE, SA, Italy
Research Site	Recruiting
VALLO DELLA LUCANIA, SA, Italy
Italy, to
Research Site	Not yet recruiting
COLLEGNO, to, Italy

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Gino Montagnani, MD	AstraZeneca
Principal Investigator:	Mario diFiorino	Ospedale Unico della Versilia (Lido di Camaiore, Lucca Italy)

More Information

Responsible Party:	AstraZeneca ( Hans Eriksson )
Study ID Numbers:	D1443L00031
Study First Received:	March 17, 2008
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00640562
Health Authority:	Italy: Ethics Committee

Keywords provided by AstraZeneca:

Schizophrenia
Depression
Quetiapine

Study placed in the following topic categories:

Schizophrenia
Quetiapine
Dopamine
Depression
Mental Disorders
Risperidone

Mood Disorders
Psychotic Disorders
Depressive Disorder
Serotonin
Schizophrenia and Disorders with Psychotic Features
Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists

Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009