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Trial record 39 of 2664 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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Schizophrenia
Depression
Interventions Drug: Quetiapine Extended Release
Drug: Risperidone
Enrollment 216
Recruitment Details Adult male and female patients. with a diagnosis of schizophrenia or schizoaffective disorder (according to DSM-IVTR criteria). with depressive symptoms HAM-D baseline score ≥ 20. and HAM-D item 1 score ≥2.
Pre-assignment Details  
Arm/Group Title Seroquel XR Risperidone
Hide Arm/Group Description Seroquel XR dose 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 dose was 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.
Period Title: Overall Study
Started 109 107
Completed 91 81
Not Completed 18 26
Reason Not Completed
Adverse Event             8             5
Lack of Efficacy             1             4
Protocol Violation             2             4
Withdrawal by Subject             6             10
Known risperidone intolerance             0             1
Past use of Seroquel -stopped due to AE             0             1
Low study drug dose             0             1
Glycosylated Hemoglobin >8             1             0
Arm/Group Title Seroquel XR Risperidone Total
Hide Arm/Group Description Seroquel XR dose 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 dose was 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. Total of all reporting groups
Overall Number of Baseline Participants 107 103 210
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 107 participants 103 participants 210 participants
42.46  (10.71) 42.08  (11.48) 42.27  (11.10)
[1]
Measure Description: Number of participants is lower than number in Participants Flow module. 6 participants, 2 in Seroquel XR and 4 in Risperidone, were not valid for safety population because they did not assume any study drug administration.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 103 participants 210 participants
Female
51
  47.7%
40
  38.8%
91
  43.3%
Male
56
  52.3%
63
  61.2%
119
  56.7%
1.Primary Outcome
Title Change From Baseline to Week 12 of Calgary Depression Scale for Schizophrenia (CDSS) Score.
Hide Description

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.

Time Frame 12 week from baseline to last visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seroquel XR Risperidone
Hide Arm/Group Description:
Seroquel XR dose 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 dose was 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.
Overall Number of Participants Analyzed 107 103
Least Squares Mean (Standard Deviation)
Unit of Measure: Score on a scale
7.31  (6.1) 5.53  (6.4)
2.Secondary Outcome
Title Change From Baseline to Week 12 of HAM-D Score
Hide Description 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.
Time Frame 12 weeks from baseline to last visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seroquel XR Risperidone
Hide Arm/Group Description:
Seroquel XR dose 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 dose was 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.
Overall Number of Participants Analyzed 107 103
Mean (Standard Deviation)
Unit of Measure: Score on scale
-29.83  (10.13) -23.02  (10.33)
3.Secondary Outcome
Title Change From Baseline to Week 12 of PANSS Score
Hide Description 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.
Time Frame 12 weeks from baseline to last visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seroquel XR Risperidone
Hide Arm/Group Description:
Seroquel XR dose 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 dose was 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.
Overall Number of Participants Analyzed 107 103
Mean (Standard Deviation)
Unit of Measure: score on scale
102.26  (24.14) 100.51  (25.65)
4.Secondary Outcome
Title - Change From Baseline to Week 12 of Clinical Global Impression (CGI- Severity of Illness) Score
Hide Description 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
Time Frame 12 weeks from baseline to last visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seroquel XR Risperidone
Hide Arm/Group Description:
Seroquel XR dose 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 dose was 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.
Overall Number of Participants Analyzed 107 103
Least Squares Mean (Standard Deviation)
Unit of Measure: Score on scale
-1.50  (1.33) -1.04  (1.31)
5.Secondary Outcome
Title CGI- Global Improvement Mean Score at Week 12
Hide Description 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
Time Frame 12week: descriptive statistic of CGI by visit and treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seroquel XR Risperidone
Hide Arm/Group Description:
Seroquel XR dose 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 dose was 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.
Overall Number of Participants Analyzed 107 103
Mean (Standard Deviation)
Unit of Measure: score on a scale
91  (4.47) 88  (4.55)
6.Secondary Outcome
Title Change From Baseline to Week 12 of Drug Attitude Inventory 10 Item Scale (DAI 10) Score
Hide Description 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
Time Frame 12 week from baseline to last visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seroquel XR Risperidone
Hide Arm/Group Description:
Seroquel XR dose 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 dose was 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.
Overall Number of Participants Analyzed 107 103
Least Squares Mean (Standard Deviation)
Unit of Measure: score on scale
86.38  (4.12) 76.64  (4.70)
7.Secondary Outcome
Title Change From Baseline in the Simpson Angus Scale (SAS) Total Score to Week 12 as an Indication of Neurological Side Effects Section
Hide Description

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.

Time Frame 12 weeks from baseline to last visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seroquel XR Risperidone
Hide Arm/Group Description:
Seroquel XR dose 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 dose was 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.
Overall Number of Participants Analyzed 107 103
Mean (Standard Deviation)
Unit of Measure: score on scale
2.74  (5.29) 3.88  (5.24)
8.Secondary Outcome
Title Concomitant Use of Antidepressive Drugs From Baseline to Week 12
Hide Description 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
Time Frame 12 week from baseline to last visi
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seroquel XR Risperidone
Hide Arm/Group Description:
Seroquel XR dose 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 dose was 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.
Overall Number of Participants Analyzed 107 103
Measure Type: Number
Unit of Measure: Participants
12 11
9.Secondary Outcome
Title Change From Screening Visit to Week 12 of Prolactin Live
Hide Description Plasma prolactin live was drawn prior to morning meal at the screening visit at the last visit
Time Frame 12 week from screening visit to last visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seroquel XR Risperidone
Hide Arm/Group Description:
Seroquel XR dose 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 dose was 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.
Overall Number of Participants Analyzed 107 103
Least Squares Mean (Standard Deviation)
Unit of Measure: KG
61.20  (29.77) 90.80  (55.78)
10.Secondary Outcome
Title Body Mass Index (BMI) at Week 12
Hide Description 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.
Time Frame 12 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seroquel XR Risperidone
Hide Arm/Group Description:
Seroquel XR dose 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 dose was 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.
Overall Number of Participants Analyzed 107 103
Mean (Standard Deviation)
Unit of Measure: Kg/m^2
29.07  (6.65) 28.80  (5.31)
11.Secondary Outcome
Title Concomitant Use of Antidepressive Drugs From Baseline to Week 12
Hide Description 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
Time Frame Change of drug use from baseline to last visi
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seroquel XR Risperidone
Hide Arm/Group Description:
Seroquel XR dose 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 dose was 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.
Overall Number of Participants Analyzed 107 103
Measure Type: Number
Unit of Measure: Participants
14 17
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Seroquel XR Risperidone
Hide Arm/Group Description Seroquel XR dose 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 dose was 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.
All-Cause Mortality
Seroquel XR Risperidone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Seroquel XR Risperidone
Affected / at Risk (%) Affected / at Risk (%)
Total   4/109 (3.67%)   4/107 (3.74%) 
Cardiac disorders     
Cardiocircolatory Arresti  1  1/109 (0.92%)  0/107 (0.00%) 
Nervous system disorders     
Extrapiramidal Syndrome  1  0/109 (0.00%)  1/107 (0.93%) 
Faint/Syndrome  1  1/109 (0.92%)  0/107 (0.00%) 
Psychiatric disorders     
Disorientation  1  0/109 (0.00%)  1/107 (0.93%) 
Psycotic Disorder  1  0/109 (0.00%)  1/107 (0.93%) 
Delusion  1  0/109 (0.00%)  1/107 (0.93%) 
Acute Psycosis  1  1/109 (0.92%)  0/107 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Failure  1  1/109 (0.92%)  0/107 (0.00%) 
Social circumstances     
Social Stay Hospitalisation  1  1/109 (0.92%)  0/107 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Seroquel XR Risperidone
Affected / at Risk (%) Affected / at Risk (%)
Total   28   21 
Endocrine disorders     
Hyperprolactinemia  1  1/109 (0.92%)  10/107 (9.35%) 
Gastrointestinal disorders     
Dry Months  1  5/109 (4.59%)  0/107 (0.00%) 
General disorders     
Asthenia  1  3/109 (2.75%)  5/107 (4.67%) 
Investigations     
Weight Increse  1  3/109 (2.75%)  2/107 (1.87%) 
Nervous system disorders     
Sedation  1  5/109 (4.59%)  1/107 (0.93%) 
Somnolence  1  6/109 (5.50%)  2/107 (1.87%) 
Vascular disorders     
Hypotension  1  5/109 (4.59%)  1/107 (0.93%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Multicentre, randomized, open-label, flexible dose, parallel group, non inferiority
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Gerard Lynch
Organization: AstraZeneca
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00640562     History of Changes
Other Study ID Numbers: D1443L00031
First Submitted: March 17, 2008
First Posted: March 21, 2008
Results First Submitted: March 29, 2011
Results First Posted: June 19, 2012
Last Update Posted: June 19, 2012