Quetiapine Extended Release Depression Symptoms

Condition(s) targeted: Schizophrenia; Depression

Intervention: Quetiapine Extended Release (Drug); Risperidone (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Gino Montagnani, MD, Study Director, Affiliation: AstraZeneca
Mario diFiorino, Principal Investigator, Affiliation: Ospedale Unico della Versilia (Lido di Camaiore, Lucca Italy)

Overall contact:
AstraZeneca Basiglio Clinical Study Inforamtion, Phone: 02-9801-59831

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.

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

Study design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Primary outcome: 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

Secondary outcome:

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)

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)

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)

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

AstraZeneca Basiglio Clinical Study Inforamtion, Phone: 02-9801-59831

Research Site, FRATTAMINORE, Italy; Recruiting

Research Site, Ravenna, Italy; Terminated

Research Site, Ceglie Messapica, Italy; Not yet recruiting

Research Site, ROMA, Italy; Recruiting

Research Site, AOSTA, AO, Italy; Not yet recruiting

Research Site, FERMO, AP, Italy; Recruiting

Research Site, BERGAMO, BG, Italy; Recruiting

Research Site, BRINDISI, BR, Italy; Recruiting

Research Site, LENO, BS, Italy; Terminated

Research Site, CARBONIA, CA, Italy; Recruiting

Research Site, Sanluri, CA, Italy; Not yet recruiting

Research Site, TERMOLI, CB, Italy; Recruiting

Research Site, Aversa, CE, Italy; Recruiting

Research Site, CATANIA, CT, Italy; Recruiting

Research Site, NICOSIA, EN, Italy; Recruiting

Research Site, LUCERA, FG, Italy; Terminated

Research Site, Firenze, FI, Italy; Not yet recruiting

Research Site, Pontecorvo, FR, Italy; Not yet recruiting

Research Site, LIDO DI CAMAIORE, LU, Italy; Recruiting

Research Site, MESSINA, ME, Italy; Recruiting

Research Site, MILAZZO, ME, Italy; Recruiting

Research Site, Monza, MI, Italy; Recruiting

Research Site, NOCERA INFERIORE, SA, Italy; Recruiting

Research Site, VALLO DELLA LUCANIA, SA, Italy; Recruiting

Research Site, La Spezia, SP, Italy; Not yet recruiting

Research Site, Bussolengo, VR, Italy; Recruiting

Research Site, COLLEGNO, to, Italy; Not yet recruiting

Starting date: February 2008
Ending date: January 2010
Last updated: July 28, 2009