Quetiapine Extended Release Depression Symptoms (ExAttitude)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00640562
First received: March 17, 2008
Last updated: May 17, 2012
Last verified: May 2012
  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 3

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change From Baseline to Week 12 of Calgary Depression Scale for Schizophrenia (CDSS) Score. [ Time Frame: 12 week from baseline to last visit ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Change From Baseline to Week 12 of HAM-D Score [ Time Frame: 12 weeks from baseline to last visit ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline to Week 12 of PANSS Score [ Time Frame: 12 weeks from baseline to last visit ] [ Designated as safety issue: No ]
    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.

  • - Change From Baseline to Week 12 of Clinical Global Impression (CGI- Severity of Illness) Score [ Time Frame: 12 weeks from baseline to last visit ] [ Designated as safety issue: No ]
    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

  • CGI- Global Improvement Mean Score at Week 12 [ Time Frame: 12week: descriptive statistic of CGI by visit and treatment ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]

    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.


  • Concomitant Use of Antidepressive Drugs From Baseline to Week 12 [ Time Frame: 12 week from baseline to last visi ] [ Designated as safety issue: No ]
    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

  • Change From Screening Visit to Week 12 of Prolactin Live [ Time Frame: 12 week from screening visit to last visit ] [ Designated as safety issue: No ]
    Plasma prolactin live was drawn prior to morning meal at the screening visit at the last visit

  • Body Mass Index (BMI) at Week 12 [ Time Frame: 12 week ] [ Designated as safety issue: No ]
    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.

  • Concomitant Use of Antidepressive Drugs From Baseline to Week 12 [ Time Frame: Change of drug use from baseline to last visi ] [ Designated as safety issue: No ]
    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


Enrollment: 216
Study Start Date: February 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Quetiapine Extended Release 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
Other Name: Seroquel XR™
Active Comparator: Risperidone Drug: 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.
Other Name: Risperdal

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Italy
Research Site
Fermo, AP, Italy
Research Site
Bergamo, BG, Italy
Research Site
Brindisi, BR, Italy
Research Site
Carbonia, CA, Italy
Research Site
Termoli, CB, Italy
Research Site
Aversa, CE, Italy
Research Site
Catania, CT, Italy
Research Site
Nicosia, EN, 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
Nocera Inferiore, SA, Italy
Research Site
Vallo Della Lucania, SA, Italy
Research Site
La Spezia, SP, Italy
Research Site
Collegno, TO, Italy
Research Site
Frattaminore, Italy
Research Site
Lecco, Italy
Research Site
Palermo, Italy
Research Site
Partinico, Italy
Research Site
Roma, Italy
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Gino Montagnani, MD AstraZeneca
Principal Investigator: Mario diFiorino Ospedale Unico della Versilia (Lido di Camaiore, Lucca Italy)
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00640562     History of Changes
Other Study ID Numbers: D1443L00031
Study First Received: March 17, 2008
Results First Received: March 29, 2011
Last Updated: May 17, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by AstraZeneca:
Schizophrenia
Depression
Quetiapine

Additional relevant MeSH terms:
Depression
Depressive Disorder
Schizophrenia
Behavioral Symptoms
Mood Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Risperidone
Quetiapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on August 21, 2014