Efficacy and Safety of SEROQUEL Extended Release (XR) in Acute Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00954122
First received: August 6, 2009
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

The purpose of the study is to determine whether treatment with quetiapine XR (Seroquel XR) tablets for 3 weeks will improve their agitation when they have acute psychosis.


Condition Intervention Phase
Schizophrenia
Drug: Quetiapine XR (Seroquel XR)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 3 Weeks Open Label Study to Evaluate the Efficacy in Agitation and Safety of Quetiapine Fumarate XR in Treatment of Patients With Acute Schizophrenia

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change From Baseline in Positive and Negative Syndrome Scale Excited Component (PANSS-EC) Score [ Time Frame: Baseline and Day 21 ] [ Designated as safety issue: No ]
    PANSS- Excited Component (EC) subscale score will be calculated by adding together the following item scores: excitement (positive subscale item 4); hostility (positive subscale item 7); tension (general subscale item 4); uncooperativeness (general subscale item 8); poor impulse control (general subscale item 14). This is rated on a 7-point Likert scale from 'absent' to 'extremely severe' (score range 5 to 35 points; mean scores = 20 points clinically corresponds to severe agitation). Lower value gives the better outcome.


Secondary Outcome Measures:
  • Change From Baseline to Final Visit at Day 21 in PANSS Positive, General Psychopathological Scores. [ Time Frame: Baseline and Day 21 ] [ Designated as safety issue: No ]

    Positive scale includes 7 Items (Delusions, Conceptual disorganization, Hallucinations, Hyperactivity, Grandiosity, Suspiciousness/persecution, Hostility)and is calculated by adding the positive subscale item scores. Minimum score is 7, maximum score is 49. General Psychopathology scale:16 items (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance). Minimum score is 16, maximum score is 112. The higher score- the worse outcome. The biggest reduction of score from baseline- a better efficacy.

    Measure includes PANSS-Positive (range 8-30), PANSS-General Psychopathological (PANSS-G)(range 17-70), total PANSS score (range 37-143), PANSS aggression, hostility and depression cluster scores (range 4-19).


  • Change From Baseline to Final Visit at Day 21 in PANSS Negative, General Psychopathological Scores [ Time Frame: Baseline and Day 21 ] [ Designated as safety issue: No ]
    Negative scale includes 7 items (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking)and is calculated by adding the negative subscale item scores. Minimum score is 7, maximum score is 49. General Psychopathology scale includes 16 Items (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance). Minimum score is 16, maximum score is 112. The higher score- the worse outcome. Measure includes PANSS-Negative (range 8-37), PANSS-General Psychopathological (PANSS-G)(range 17-70), total PANSS score (range 37-143), PANSS aggression, hostility and depression cluster scores (range 4-19).

  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score [ Time Frame: Baseline and Day 21 ] [ Designated as safety issue: No ]
    Positive and Negative Syndrome Scale (PANSS) total score is a medical scale used for measuring symptom severity of patients with schizophrenia. It is calculated by adding together PANSS-Positive (minimum score = 7, maximum score = 49, PANSS-Negative (minimum score = 7, maximum score = 49), PANSS-General Psychopathological (PANSS-G) subscale scores (minimum score = 16, maximum score = 112), supplementary subscale item scores. The minimum is 30, maximum is 210. Total PANSS score classification: Mildly ill 58- 74, Moderately ill 75-94, Markly ill 95- 115, Severely ill >116.

  • Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) [ Time Frame: Baseline and Day 21 ] [ Designated as safety issue: No ]

    Clinical Global Impression, Severity (CGI-S) is a single-item (7-point) scale that evaluates the overall severity of the subject's mental illness. A reduction in score indicates an improvement in the subject's condition. The CGI-S assessment should be based upon the subject's symptoms during the previous week.

    Change from baseline in CGI-S score is calculated by subtracting the CGI-S score at baseline from the CGI-S score at the relevant time point.


  • Change From Baseline in Absolute Clinical Global Impression-Improvement (CGI-I) Scale [ Time Frame: Baseline and Day 21 ] [ Designated as safety issue: No ]

    Clinical Global Impression, Improvement (CGI-I) is a single-item (7-point) scale that evaluates the overall improvement in the subject's mental. A reduction in score indicates an improvement in the subject's condition. This assessment is based on the improvement since initiation of the study treatment.

    Change in CGI-I score is analyzed by comparing CSI-score at the relevant time point to the baseline CGI-I score.


  • Change of the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) Score Compared From Baseline to Day 21. [ Time Frame: Baseline and Day 21 ] [ Designated as safety issue: No ]

    Excited Component was used to evaluate the control of agitation and aggression in patients with schizophrenia.

    Difference in mean score at baseline and day 21 is used to assess the improvement. It is shown by reduction in mean score and confirmed by p value lower than 0,05.

    Positive and Negative Syndrome Scale Excited Component (PANSS-EC) is a subscale score which is calculated by adding together the following item scores: excitement (positive subscale item 4); hostility (positive subscale item 7); tension (general subscale item 4); uncooperativeness (general subscale item 8); poor impulse control (general subscale item 14).

    This is rated on a 7-point Likert scale from 'absent' to 'extremely severe' (score range 5 to 35 points; mean scores = 20 points clinically corresponds to severe agitation).



Enrollment: 35
Study Start Date: September 2009
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Quetiapine XR
Quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards.
Drug: Quetiapine XR (Seroquel XR)
Tablet, oral, once daily
Other Name: Seroquel XR

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Requirement for treatment of acute episode of schizophrenia (according to DSM-IV diagnostic criteria)
  • PANSS total score of ³ 75
  • CGI > 4

Exclusion Criteria:

  • Any DSM-IV (Diagnostic and Statistical Manual of Mental Disorders 4th Edition) Axis I disorder not defined in the inclusion criteria
  • Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
  • Substance or alcohol dependence at enrollment
  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: NCT00954122

Locations
Malaysia
Research Site
Johor, Johor Bahru, Malaysia
Research Site
Kuala Lumpur, Malaysia
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Ahmad Hatim Sulaiman,, M Psyc University Malaya Medical Centre
Principal Investigator: Badiah Yahya, MD Hospital Permai
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00954122     History of Changes
Other Study ID Numbers: D1443L00074
Study First Received: August 6, 2009
Results First Received: May 18, 2011
Last Updated: January 7, 2013
Health Authority: Malaysia: Ministry of Health

Keywords provided by AstraZeneca:
Acute schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 29, 2014