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Trial record 39 of 2690 for:    "Depressive Disorder" [DISEASE] AND depressive symptoms

Quetiapine Extended Release Depression Symptoms (ExAttitude)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00640562
Recruitment Status : Completed
First Posted : March 21, 2008
Results First Posted : June 19, 2012
Last Update Posted : June 19, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE March 17, 2008
First Posted Date  ICMJE March 21, 2008
Results First Submitted Date  ICMJE March 29, 2011
Results First Posted Date  ICMJE June 19, 2012
Last Update Posted Date June 19, 2012
Study Start Date  ICMJE February 2008
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 17, 2008)
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
Change History Complete list of historical versions of study NCT00640562 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2012)
  • Change From Baseline to Week 12 of HAM-D Score [ Time Frame: 12 weeks from baseline to last visit ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2008)
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Quetiapine Extended Release Depression Symptoms
Official Title  ICMJE 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
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Depression
Intervention  ICMJE
  • 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™
  • 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
Study Arms  ICMJE
  • Experimental: Quetiapine Extended Release
    Intervention: Drug: Quetiapine Extended Release
  • Active Comparator: Risperidone
    Intervention: Drug: Risperidone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 23, 2009)
216
Original Estimated Enrollment  ICMJE
 (submitted: March 17, 2008)
290
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00640562
Other Study ID Numbers  ICMJE D1443L00031
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Gino Montagnani, MD AstraZeneca
Principal Investigator: Mario diFiorino Ospedale Unico della Versilia (Lido di Camaiore, Lucca Italy)
PRS Account AstraZeneca
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP