Trial · NCT00672490
Quetiapine Fumarate (Seroquel) as Mono-Therapy or Adjunct to Lithium in the Treatment of Patients With Acute Mania in Bipolar Disorder
NCT00672490, Phase 4, Completed, AstraZeneca; results first posted 2012-07-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Quetiapine Fumarate (Seroquel) as Mono-Therapy or Adjunct to Lithium in the Treatment of Patients With Acute Mania in Bipolar Disorder. Trials, record NCT00672490. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00672490
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Quetiapine Fumarate (Seroquel) as Mono-Therapy or Adjunct to Lithium in the Treatment of Patients With Acute Mania in Bipolar Disorder
- NCT number
- NCT00672490
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 376 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Acute Mania in Bipolar Disorder
- Interventions
- Quetiapine Fumarate, Lithium
- First posted
- 2008-05-06
- Last updated
- 2012-07-12
- Results first posted
- 2012-07-12
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 28) | Baseline and 4 weeks | The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania). |
| Secondary | Change From Baseline in the Clinical Global Impressions for Bipolar Disorder Severity of Illness (CGI-BP-S) Score to Each Assessment (Day 28) | Baseline and 4 weeks | The CGI-BP-S scale rates the severity of the patient's illness at the time of assessment and is scored from 1 to 7 (1=normal, not ill to 7=very severely ill). Higher CGI-BP-S scores indicate greater illness severity |
| Secondary | Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score to Each Assessment (Day 28) | Baseline and 4 weeks | The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 individual-item scores and ranges from 30 to 210 |
| Secondary | Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score to Each Assessment(Day 28) | Baseline and 4 weeks | The MADRS is a 10-item scale that evaluates depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. Higher MADRS scores indicate higher levels of depressive symptoms. The MADRS total score is the sum of all 10 individual-item scores and ranges from 0 to 60. |
| Secondary | Change From Baseline in the Young Mania Rating Scale (YMRS) Item 4 Score to Each Assessment | Baseline and 4 weeks | The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 4 (sleep) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. |
| Secondary | Response Rate (Number of Patients With Clinically Response) | From Baseline to 4 weeks | The number of patients with clinically response (defined as ≥50% reduction in the YMRS total score from baseline to Day 28) was calculated. The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or 50% reduction) from baseline indicates a reduction (or improvement) in manic symptoms. |
| Secondary | Remission Rate (Number of Patients With Clinically Significant Remission) | From Baseline to 4 weeks | The number of patients with clinically significant remission (defined as YMRS total score ≤12) at Day 28 was calculated. The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania. Total score ≤12 indicates remission. |
| Secondary | Treatment of Agitation (Change From Baseline in the PANSS Activation Subscale Score to Day 28) | Baseline and 4 weeks | The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS activation subscale score for effect on agitation and aggression is the sum of 6 PANSS individual items (ie, hostility, poor impulse control, excitement, uncooperativeness, poor rapport and tension) and ranges from 6 to 42. |
| Secondary | Treatment of Aggression Risk (Change From Baseline in the PANSS Supplement Aggression Risk Subscale Score to Day 28) | Baseline and 4 weeks | The PANSS Supplemental Aggression Risk subscale score is the sum of 3 standard PANSS items - Excitement, Hostility and Depression - and 3 supplemental PANSS items related to anger - Anger, Difficulty in Delaying Gratification and Affective Lability and ranges from 6 to 42, where 6 is the "best" and 42 the "worst" score for the combined scale. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 28) | Baseline and 4 weeks | Per Protocol Population | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Clinical Global Impressions for Bipolar Disorder Severity of Illness (CGI-BP-S) Score to Each Assessment (Day 28) | Baseline and 4 weeks | score on a scale | MEAN | |
| SECONDARY | Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score to Each Assessment (Day 28) | Baseline and 4 weeks | units on a scale | MEAN | |
| SECONDARY | Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score to Each Assessment(Day 28) | Baseline and 4 weeks | score on a scale | MEAN | |
| SECONDARY | Change From Baseline in the Young Mania Rating Scale (YMRS) Item 4 Score to Each Assessment | Baseline and 4 weeks | score on a scale | MEAN | |
| SECONDARY | Response Rate (Number of Patients With Clinically Response) | From Baseline to 4 weeks | Participants | NUMBER | |
| SECONDARY | Remission Rate (Number of Patients With Clinically Significant Remission) | From Baseline to 4 weeks | Participants | NUMBER | |
| SECONDARY | Treatment of Agitation (Change From Baseline in the PANSS Activation Subscale Score to Day 28) | Baseline and 4 weeks | score on a scale | MEAN | |
| SECONDARY | Treatment of Aggression Risk (Change From Baseline in the PANSS Supplement Aggression Risk Subscale Score to Day 28) | Baseline and 4 weeks | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 28) | Quetiapine Fumarate Used as Mono-Therapy | -25.7 | Standard Deviation 13.7 | score on a scale | |
| Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 28) | Quetiapine Fumarate Used as Adjunct Therapy | -26.1 | Standard Deviation 13.4 | score on a scale | |
| Change From Baseline in the Clinical Global Impressions for Bipolar Disorder Severity of Illness (CGI-BP-S) Score to Each Assessment (Day 28) | Quetiapine Fumarate Used as Mono-Therapy | -2.65 | Standard Deviation 0.115 | score on a scale | |
| Change From Baseline in the Clinical Global Impressions for Bipolar Disorder Severity of Illness (CGI-BP-S) Score to Each Assessment (Day 28) | Quetiapine Fumarate Used as Adjunct Therapy | -0.17 | Standard Deviation 0.144 | score on a scale | |
| Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score to Each Assessment (Day 28) | Quetiapine Fumarate Used as Mono-Therapy | -16.12 | Standard Deviation 0.285 | units on a scale | |
| Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score to Each Assessment (Day 28) | Quetiapine Fumarate Used as Adjunct Therapy | -16.44 | Standard Deviation 0.28 | units on a scale | |
| Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score to Each Assessment(Day 28) | Quetiapine Fumarate Used as Mono-Therapy | -2.99 | Standard Deviation 0.181 | score on a scale | |
| Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score to Each Assessment(Day 28) | Quetiapine Fumarate Used as Adjunct Therapy | -3.02 | Standard Deviation 0.179 | score on a scale | |
| Change From Baseline in the Young Mania Rating Scale (YMRS) Item 4 Score to Each Assessment | Quetiapine Fumarate Used as Mono-Therapy | -2.0 | Standard Deviation 1.2 | score on a scale | |
| Change From Baseline in the Young Mania Rating Scale (YMRS) Item 4 Score to Each Assessment | Quetiapine Fumarate Used as Adjunct Therapy | -2.1 | Standard Deviation 1.2 | score on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Quetiapine Fumarate Used as Mono-Therapy | 187 | |
| Overall Study | STARTED | Quetiapine Fumarate Used as Adjunct Therapy | 189 | |
| Overall Study | COMPLETED | Quetiapine Fumarate Used as Mono-Therapy | 163 | |
| Overall Study | COMPLETED | Quetiapine Fumarate Used as Adjunct Therapy | 157 | |
| Overall Study | NOT COMPLETED | Quetiapine Fumarate Used as Mono-Therapy | 24 | |
| Overall Study | NOT COMPLETED | Quetiapine Fumarate Used as Adjunct Therapy | 32 |
Source ClinicalTrials.gov
Adverse events38
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 | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Quetiapine Fumarate Used as Mono-Therapy | 13 | 187 | |
| other | Constipation | Gastrointestinal disorders | Quetiapine Fumarate Used as Adjunct Therapy | 24 | 189 | |
| other | Nausea | Gastrointestinal disorders | Quetiapine Fumarate Used as Mono-Therapy | 4 | 187 | |
| other | Nausea | Gastrointestinal disorders | Quetiapine Fumarate Used as Adjunct Therapy | 15 | 189 | |
| other | Vomiting | Gastrointestinal disorders | Quetiapine Fumarate Used as Mono-Therapy | 1 | 187 | |
| other | Vomiting | Gastrointestinal disorders | Quetiapine Fumarate Used as Adjunct Therapy | 10 | 189 | |
| other | Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Quetiapine Fumarate Used as Mono-Therapy | 14 | 187 | |
| other | Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Quetiapine Fumarate Used as Adjunct Therapy | 12 | 189 | |
| other | Weight Increased | Investigations | Quetiapine Fumarate Used as Mono-Therapy | 12 | 187 | |
| other | Weight Increased | Investigations | Quetiapine Fumarate Used as Adjunct Therapy | 16 | 189 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Quetiapine Fumarate Used as Mono-Therapy | ||
| Total, all-cause mortality | Quetiapine Fumarate Used as Adjunct Therapy | ||
| Total, other adverse events | Quetiapine Fumarate Used as Mono-Therapy | 120 | 187 |
| Total, other adverse events | Quetiapine Fumarate Used as Adjunct Therapy | 125 | 189 |
| Total, serious adverse events | Quetiapine Fumarate Used as Mono-Therapy | 0 | 187 |
| Total, serious adverse events | Quetiapine Fumarate Used as Adjunct Therapy | 1 | 189 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|
| Quetiapine Fumarate Used as Mono-Therapy vs Quetiapine Fumarate Used as Adjunct Therapy: Response Rate (Number of Patients With Clinically Response) | Trial comparisons |
| Quetiapine Fumarate Used as Mono-Therapy vs Quetiapine Fumarate Used as Adjunct Therapy: Remission Rate (Number of Patients With Clinically Significant Remission) | Trial comparisons |
| Quetiapine Fumarate Used as Mono-Therapy vs Quetiapine Fumarate Used as Adjunct Therapy: 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.
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/NCT00672490
GET https://conductscience.org/api/trials/v1/NCT00672490/events?page=2