SchizophreniaPhase 3ExAttitudeNCT00640562

Quetiapine Extended Release Depression Symptoms

A Phase 3 study testing Quetiapine Extended Release and Risperidone in people with Schizophrenia and Depression, run by AstraZeneca at 21 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia, Depression
What is being tested?: Quetiapine Extended Release and Risperidone
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 216 participants
Where: 21 sitesItaly
Study dates: Feb 2008to Feb 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

Italy21 sites

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

Other trials in Italy

About this study

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

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.

Conditions: Schizophrenia, Depression
Being tested: Quetiapine Extended Release, Risperidone
Keywords: Schizophrenia, Depression, Quetiapine
Medical subject headings: Schizophrenia, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Quetiapine Extended ReleaseDrug
Also called Seroquel XR™
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
RisperidoneDrug
Also called Risperdal
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.

Study groups in NCT00640562
Study group	Role	What they receive
Quetiapine Extended Release	Experimental	Not described Receives: Drug: Quetiapine Extended Release
Risperidone	Active comparator	Not described Receives: Drug: Risperidone

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 week from baseline to last visit

Secondary outcomes (10)

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.
Measured: 12 weeks from baseline to last visit
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.
Measured: 12 weeks from baseline to last visit
- 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
Measured: 12 weeks from baseline to last visit
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
Measured: 12week: descriptive statistic of CGI by visit and treatment
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
Measured: 12 week from baseline to last visit
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.
Measured: 12 weeks from baseline to last visit
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
Measured: 12 week from baseline to last visi
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
Measured: 12 week from screening visit to last visit
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.
Measured: 12 week
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
Measured: Change of drug use from baseline to last visi

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2008Feb 2010

First posted21 Mar 2008 (estimated)
Study startFeb 2008
Primary completionFeb 2010
Study completionFeb 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 216 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00640562
Sponsor's protocol ID: D1443L00031
Acronym: ExAttitude
Status last verified: May 2012
First submitted: 17 Mar 2008
Last updated: 19 Jun 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kasper S, Montagnani G, Trespi G, Di Fiorino M. Treatment of depressive symptoms in patients with schizophrenia: a randomized, open-label, parallel-group, flexible-dose subgroup analysis of patients treated with extended-release quetiapine fumarate or risperidone. Int Clin Psychopharmacol. 2015 Jan;30(1):14-22. doi: 10.1097/YIC.0000000000000053.
PubMed 25356632
Di Fiorino M, Montagnani G, Trespi G, Kasper S. Extended-release quetiapine fumarate (quetiapine XR) versus risperidone in the treatment of depressive symptoms in patients with schizoaffective disorder or schizophrenia: a randomized, open-label, parallel-group, flexible-dose study. Int Clin Psychopharmacol. 2014 May;29(3):166-76. doi: 10.1097/YIC.0000000000000017.
PubMed 24681810

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00640562
Acronym / sponsor ID: ExAttitude / D1443L00031
Conditions: Schizophrenia, Depression
Keywords: Schizophrenia, Depression, Quetiapine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 216 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Feb 2010 (actual)
Study completion: Feb 2010 (actual)
First posted: 21 Mar 2008 (estimated)
Results: Posted 19 Jun 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Quetiapine Extended Release	Experimental	Drug: Quetiapine Extended Release
Risperidone	Active comparator	Drug: Risperidone

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Quetiapine Extended ReleaseAlso: Seroquel XR™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	Drug	Quetiapine Extended Release
RisperidoneAlso: RisperdalUptitrated 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.	Drug	Risperidone

Primary outcome

Change From Baseline to Week 12 of Calgary Depression Scale for Schizophrenia (CDSS) Score.
Time frame: 12 week from baseline to last visit
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.

10 secondary outcomes

Change From Baseline to Week 12 of HAM-D Score
Time frame: 12 weeks from baseline to last visit
Change From Baseline to Week 12 of PANSS Score
Time frame: 12 weeks from baseline to last visit
- Change From Baseline to Week 12 of Clinical Global Impression (CGI- Severity of Illness) Score
Time frame: 12 weeks from baseline to last visit
CGI- Global Improvement Mean Score at Week 12
Time frame: 12week: descriptive statistic of CGI by visit and treatment
Change From Baseline to Week 12 of Drug Attitude Inventory 10 Item Scale (DAI 10) Score
Time frame: 12 week from baseline to last visit
Change From Baseline in the Simpson Angus Scale (SAS) Total Score to Week 12 as an Indication of Neurological Side Effects Section
Time frame: 12 weeks from baseline to last visit
Concomitant Use of Antidepressive Drugs From Baseline to Week 12
Time frame: 12 week from baseline to last visi
Change From Screening Visit to Week 12 of Prolactin Live
Time frame: 12 week from screening visit to last visit
Body Mass Index (BMI) at Week 12
Time frame: 12 week
Concomitant Use of Antidepressive Drugs From Baseline to Week 12
Time frame: Change of drug use from baseline to last visi

Results and safety

Results posted to the registry on 19 Jun 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Seroquel XR	109	91
Risperidone	107	81

Primary outcome: Change From Baseline to Week 12 of Calgary Depression Scale for Schizophrenia (CDSS) Score.

Time frame: 12 week from baseline to last visit. Least squares mean (Standard Deviation). Unit: Score on a scale

Measure	Seroquel XR n = 107	Risperidone n = 103
Value	7.31 (6.1)	5.53 (6.4)

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Seroquel XR	4 of 109 (3.7%)	28 of ?	Not reported
Risperidone	4 of 107 (3.7%)	21 of ?	Not reported

Limitations and caveats (from the sponsor): Multicentre, randomized, open-label, flexible dose, parallel group, non inferiority

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25356632Kasper S, Montagnani G, Trespi G, Di Fiorino M. Treatment of depressive symptoms in patients with schizophrenia: a randomized, open-label, parallel-group, flexible-dose subgroup analysis of patients treated with extended-release quetiapine fumarate or risperidone. Int Clin Psychopharmacol. 2015 Jan;30(1):14-22. doi: 10.1097/YIC.0000000000000053.
Derived from this study: PubMed 24681810Di Fiorino M, Montagnani G, Trespi G, Kasper S. Extended-release quetiapine fumarate (quetiapine XR) versus risperidone in the treatment of depressive symptoms in patients with schizoaffective disorder or schizophrenia: a randomized, open-label, parallel-group, flexible-dose study. Int Clin Psychopharmacol. 2014 May;29(3):166-76. doi: 10.1097/YIC.0000000000000017.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gino Montagnani, MD study chair

AstraZeneca

Mario diFiorino principal investigator

Ospedale Unico della Versilia (Lido di Camaiore, Lucca Italy)

21 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Quetiapine Extended Release and Risperidone in people with Schizophrenia and Depression, run by AstraZeneca at 21 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 12 of Calgary Depression Scale for Schizophrenia (CDSS) Score. (time frame: 12 week from baseline to last visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00640562, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2012.