Trial · NCT00640562

Quetiapine Extended Release Depression Symptoms

NCT00640562, Phase 3, Completed, AstraZeneca; results first posted 2012-06-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Quetiapine Extended Release Depression Symptoms. Trials, record NCT00640562. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00640562

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Quetiapine Extended Release Depression Symptoms
NCT number: NCT00640562
Status: Completed
Phases: Phase 3
Enrollment: 216 participants, actual
Lead sponsor: AstraZeneca
Conditions: Schizophrenia, Depression
Interventions: Quetiapine Extended Release, Risperidone
First posted: 2008-03-21
Last updated: 2012-06-19
Results first posted: 2012-06-19
Limitations and caveats: Multicentre, randomized, open-label, flexible dose, parallel group, non inferiority

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline to Week 12 of Calgary Depression Scale for Schizophrenia (CDSS) Score.	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.
Secondary	Change From Baseline to Week 12 of HAM-D Score	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.
Secondary	Change From Baseline to Week 12 of PANSS Score	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.
Secondary	- Change From Baseline to Week 12 of Clinical Global Impression (CGI- Severity of Illness) Score	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
Secondary	CGI- Global Improvement Mean Score at Week 12	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
Secondary	Change From Baseline to Week 12 of Drug Attitude Inventory 10 Item Scale (DAI 10) Score	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
Secondary	Change From Baseline in the Simpson Angus Scale (SAS) Total Score to Week 12 as an Indication of Neurological Side Effects Section	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.
Secondary	Concomitant Use of Antidepressive Drugs From Baseline to Week 12	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
Secondary	Change From Screening Visit to Week 12 of Prolactin Live	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
Secondary	Body Mass Index (BMI) at Week 12	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.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change From Baseline to Week 12 of Calgary Depression Scale for Schizophrenia (CDSS) Score.	12 week from baseline to last visit	Score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 12 of HAM-D Score	12 weeks from baseline to last visit	Score on scale	MEAN
SECONDARY	Change From Baseline to Week 12 of PANSS Score	12 weeks from baseline to last visit	score on scale	MEAN
SECONDARY	- Change From Baseline to Week 12 of Clinical Global Impression (CGI- Severity of Illness) Score	12 weeks from baseline to last visit	Score on scale	LEAST_SQUARES_MEAN
SECONDARY	CGI- Global Improvement Mean Score at Week 12	12week: descriptive statistic of CGI by visit and treatment	score on a scale	MEAN
SECONDARY	Change From Baseline to Week 12 of Drug Attitude Inventory 10 Item Scale (DAI 10) Score	12 week from baseline to last visit	score on scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Simpson Angus Scale (SAS) Total Score to Week 12 as an Indication of Neurological Side Effects Section	12 weeks from baseline to last visit	score on scale	MEAN
SECONDARY	Concomitant Use of Antidepressive Drugs From Baseline to Week 12	12 week from baseline to last visi	Participants	NUMBER
SECONDARY	Change From Screening Visit to Week 12 of Prolactin Live	12 week from screening visit to last visit	KG	LEAST_SQUARES_MEAN
SECONDARY	Body Mass Index (BMI) at Week 12	12 week	Kg/m^2	MEAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group22

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline to Week 12 of Calgary Depression Scale for Schizophrenia (CDSS) Score.	Seroquel XR	7.31	Standard Deviation 6.1	Score on a scale
Change From Baseline to Week 12 of Calgary Depression Scale for Schizophrenia (CDSS) Score.	Risperidone	5.53	Standard Deviation 6.4	Score on a scale
Change From Baseline to Week 12 of HAM-D Score	Seroquel XR	-29.83	Standard Deviation 10.13	Score on scale
Change From Baseline to Week 12 of HAM-D Score	Risperidone	-23.02	Standard Deviation 10.33	Score on scale
Change From Baseline to Week 12 of PANSS Score	Seroquel XR	102.26	Standard Deviation 24.14	score on scale
Change From Baseline to Week 12 of PANSS Score	Risperidone	100.51	Standard Deviation 25.65	score on scale
- Change From Baseline to Week 12 of Clinical Global Impression (CGI- Severity of Illness) Score	Seroquel XR	-1.50	Standard Deviation 1.33	Score on scale
- Change From Baseline to Week 12 of Clinical Global Impression (CGI- Severity of Illness) Score	Risperidone	-1.04	Standard Deviation 1.31	Score on scale
CGI- Global Improvement Mean Score at Week 12	Seroquel XR	91	Standard Deviation 4.47	score on a scale
CGI- Global Improvement Mean Score at Week 12	Risperidone	88	Standard Deviation 4.55	score on a scale

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Seroquel XR	109
Overall Study	STARTED	Risperidone	107
Overall Study	COMPLETED	Seroquel XR	91
Overall Study	COMPLETED	Risperidone	81
Overall Study	NOT COMPLETED	Seroquel XR	18
Overall Study	NOT COMPLETED	Risperidone	26

Source ClinicalTrials.gov

Adverse events32

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Hyperprolactinemia	Endocrine disorders	Seroquel XR	1	109
other	Hyperprolactinemia	Endocrine disorders	Risperidone	10	107
other	Dry Months	Gastrointestinal disorders	Seroquel XR	5	109
other	Dry Months	Gastrointestinal disorders	Risperidone	0	107
other	Asthenia	General disorders	Seroquel XR	3	109
other	Asthenia	General disorders	Risperidone	5	107
other	Weight Increse	Investigations	Seroquel XR	3	109
other	Weight Increse	Investigations	Risperidone	2	107
other	Sedation	Nervous system disorders	Seroquel XR	5	109
other	Sedation	Nervous system disorders	Risperidone	1	107

1 to 10 of 32Source ClinicalTrials.gov

See all 32 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Seroquel XR
Total, all-cause mortality	Risperidone
Total, other adverse events	Seroquel XR	28
Total, other adverse events	Risperidone	21
Total, serious adverse events	Seroquel XR	4	109
Total, serious adverse events	Risperidone	4	107

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
24681810	DERIVED	PubMed
25356632	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Seroquel XR vs Risperidone: Concomitant Use of Antidepressive Drugs From Baseline to Week 12	Trial comparisons
Seroquel XR vs Risperidone: Concomitant Use of Antidepressive Drugs From Baseline to Week 12	Trial comparisons
Seroquel XR vs Risperidone: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00640562

GET https://conductscience.org/api/trials/v1/NCT00640562/results?page=2

API reference For AI assistants