Quetiapine Extended Release Depression Symptoms

Depression Clinical Trial

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Official title:

Comparison of Quetiapine Extended-Release (Seroquel XR™) and Risperidone in the Treatment of Depressive Symptoms, in Schizophrenic or Schizoaffective Patients: A Randomized, Open Label, Flexible-dose, Parallel Group, Non Inferiority, 12-week Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00640562
• Other study ID #: D1443L00031
• Status: Completed
• Phase: Phase 3
• First received: March 17, 2008
• Last updated: May 17, 2012
• Start date: February 2008
• Est. completion date: February 2010

Study information

• Verified date: May 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Schizophrenia

Intervention

Drug:
• Quetiapine Extended Release
Uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
• Risperidone
Uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.

Locations

Country	Name	City	State
Italy	Research Site	Aversa	CE
Italy	Research Site	Bergamo	BG
Italy	Research Site	Brindisi	BR
Italy	Research Site	Carbonia	CA
Italy	Research Site	Catania	CT
Italy	Research Site	Collegno	TO
Italy	Research Site	Fermo	AP
Italy	Research Site	Frattaminore
Italy	Research Site	La Spezia	SP
Italy	Research Site	Lecco
Italy	Research Site	Lido Di Camaiore	LU
Italy	Research Site	Messina	ME
Italy	Research Site	Milazzo	ME
Italy	Research Site	Monza	MI
Italy	Research Site	Nicosia	EN
Italy	Research Site	Nocera Inferiore	SA
Italy	Research Site	Palermo
Italy	Research Site	Partinico
Italy	Research Site	Roma
Italy	Research Site	Termoli	CB
Italy	Research Site	Vallo Della Lucania	SA

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 12 of Calgary Depression Scale for Schizophrenia (CDSS) Score.	The CDSS scale is used to assess the level of depression in schizophrenia and to estimate the severity of depressive symptoms.; CDSS has 9 items rated on four-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Anchor point descriptions are provided to aid differentiation between each item score. The first eight items are rated on basis of patients' responses to questions; the 9 item is based on clinician's assessment.; The sum score is derived by adding the point score of all items (from 0 to 27 points); total score 4-5 is considered for minor depression and 6-7 score for major depression.	12 week from baseline to last visit	No
Secondary	Change From Baseline to Week 12 of HAM-D Score	21-item scale for depression. Symptoms are rated finely (on a 5-point scale: absent; doubtful or trivial; mild: moderate severe) or coarsely (on a 3- point scale: absent; doubtful or mild; obvious, distinct, or severe).Total score range 0- 66, higher values represent worse outcome.Number of participants refers to valid for efficacy per protocol. Change:total score at week 12 minus total score at baseline.	12 weeks from baseline to last visit	No
Secondary	Change From Baseline to Week 12 of PANSS Score	30-item scale where each symptom is rated on a severity ranging from 1-7. Symptoms are categorized into 7 items referring to positive, 7 items referring to negative and 16 general psychotic. Total score range 30- 210, higher values represent worse outcome. Number of participants analyzed refers to valid for efficacy per protocol population.	12 weeks from baseline to last visit	No
Secondary	- Change From Baseline to Week 12 of Clinical Global Impression (CGI- Severity of Illness) Score	The CGI-S subset ranges from 1 to 7 such that a score of 1 indicates "normal, not at all ill", while a score of 7 indicates "among the most extremely ill of patients". The change from start of treatment (baseline V2) in the Severity of Illness will be calculated by subtracting the score at start of treatment (baseline V2) from the following visits	12 weeks from baseline to last visit	No
Secondary	CGI- Global Improvement Mean Score at Week 12	The CGI-S subset ranges from 1 to 7 such that a score of 1 indicates "normal, not at all ill", while a score of 7 indicates "among the most extremely ill of patients". The change from start of treatment (baseline V2) in the Severity of Illness will be calculated by subtracting the score at start of treatment (baseline V2) from the following visits	12week: descriptive statistic of CGI by visit and treatment	No
Secondary	Change From Baseline to Week 12 of Drug Attitude Inventory 10 Item Scale (DAI 10) Score	These items are presented as self-report statements with which the patient agrees or disagrees. Each response is scored as +1 if correct or -1 if incorrect. The final score is the grand total of the positive and negative points. A positive score means a positive subjective response. A negative total score means a negative subjective response	12 week from baseline to last visit	No
Secondary	Change From Baseline in the Simpson Angus Scale (SAS) Total Score to Week 12 as an Indication of Neurological Side Effects Section	Extrapyramidal Side Effects (EPS) will be assessed using the Simpson-Angus Scale (SAS; Simpson GN et al 1970) . The CRF is source data for these assessments and day 0 is considered as baseline.; The SAS scale, containing 10 items, will be rated on a five-point scale where 0 is normal and 4 are severe symptoms. Min score =0, max score 40; Change from start of treatment (day 0) will be calculated as the visit score minus the score at start of treatment for each of the neurological assessments.	12 weeks from baseline to last visit	No
Secondary	Concomitant Use of Antidepressive Drugs From Baseline to Week 12	Number of concomitant users of antidepressive drugs during the study; the number of participants analyzed refers to safety population, that is to overall participants excluding 6 participants who did not assume any study drug administration	12 week from baseline to last visi	No
Secondary	Change From Screening Visit to Week 12 of Prolactin Live	Plasma prolactin live was drawn prior to morning meal at the screening visit at the last visit	12 week from screening visit to last visit	No
Secondary	Body Mass Index (BMI) at Week 12	Patient weight and height have been be collected in order to assess the Body Mass Index (BMI). The mean BMI values reported are assessed after 12 weeks of treatment.	12 week	No
Secondary	Concomitant Use of Antidepressive Drugs From Baseline to Week 12	Number of concomitant users of antidepressive drugs during the study; the number of participants analyzed refers to ITT/safety population, that is to overall participants excluding the 6 participants who did not assume any study drug administration	Change of drug use from baseline to last visi	No