Trial · NCT00206102
A Study of the Cataractogenic Potential of Seroquel and Risperdal in the Treatment of Participants With Schizophrenia or Schizoaffective Disorder
NCT00206102, Phase 4, Completed, AstraZeneca; results first posted 2011-07-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of the Cataractogenic Potential of Seroquel and Risperdal in the Treatment of Participants With Schizophrenia or Schizoaffective Disorder. Trials, record NCT00206102. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00206102
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Cataractogenic Potential of Seroquel and Risperdal in the Treatment of Participants With Schizophrenia or Schizoaffective Disorder
- NCT number
- NCT00206102
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,098 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Interventions
- quetiapine fumarate, risperidone
- First posted
- 2005-09-21
- Last updated
- 2013-01-14
- Results first posted
- 2011-07-13
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Presence of a Cortical (C) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the Lens Opacities Classification System II (LOCS II ) Grading Scale | Randomization to Month 24 | Presence of C type of cataractogenic potential event in participant was defined if any LOCS II grades of 2, 3, 4, 5 (with any grade of 0, trace,1 at randomization) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0= no cataract; 5 is worst. There are no subscales. 0 is the best, 5 is the worst. |
| Primary | Presence of a Nuclear Opalescence (N) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the LOCS II Grading Scale | Randomization to Month 24 | Presence of N type of cataractogenic potential event in Participants was defined if any LOCS II grades of 2, 3, 4 (with grade at rand equals 0,1), or if the LOCS II grades of 3,or 4 (with grade at randomization=2) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0 is the best, 4 is the worst. |
| Primary | Presence of a Posterior Subcapsular (P) Type Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the LOCS II Grading Scale | Randomization to Month 24 | Presence of P type of cataractogenic potential event in participant was defined if any LOCS II grades of 1, 2, 3 , 4 (with grade=0 at randomization) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0 is the best, 4 is the worst. |
| Secondary | Change in the Positive and Negative Syndrome Scale (PANSS) Total Score | Randomization to Month 24 | PANSS total score equals sum of the 30-items scores (range: 30-210). Each item has ( 1-7 units), 1 indicates "absent" psychosis symptom, and 7 - "extreme" symptom degree. Change in PANSS total score : total score at month 24 minus total score at randomization.Alleviation of psychotic symptoms are indicated by a negative change in PANSS total score. |
| Secondary | Change in the PANSS Positive Subscale Score | Randomization to Month 24 | PANSS Positive subscale score equals sum of the 7-items scores(range:7-49). Each item has ( 1-7 units), 1 indicates "absent" psychosis symptom, and 7 - "extreme" symptom degree. |
| Secondary | Change in the PANSS Negative Subscale Score | Randomization to Month 24 | PANSS Negative subscale score equals sum of the 7-items scores(range:7-49). Each item has ( 1-7 units), 1 indicates "absent" psychosis symptom, and 7 - "extreme" symptom degree. Change in PANSS Negative subscale score:score at month 24 minus score at randomization. Alleviation of negative psychotic symptoms are indicated by a negative change score. |
| Secondary | Change in the PANSS Psychopathology Subscale Score | Randomization to Month 24 | PANSS psychopathology subscale score equals sum of the 16-items scores(range:16-112). Each item has ( 1-7 units),1= "absent" psychosis symptom, 7= "extreme" symptom degree.Change in PANSS psychopathology subscale:score at month 24 minus score at randomization. Alleviation of general psychopathology symptoms are indicated by a negative change score. |
| Secondary | Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score | Randomization to Month 24 | CGI-S score is accessed on a seven-graded scale ranging from most extremely ill/ very much worse (7) to normal/very much improved (1) , 1 is best. Change : score at month 24 minus score at randomization. |
| Secondary | Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q SF) Total Score | Randomization to Month 24 | Q-LES-Q total score is the sum of the 16 times of Q-LES-Q SF(range:16-80).Each item has a 5 point satisfaction level scale:from 1=very poor(worst value) to 5=very good(best).Larger values indicate a higher perceived quality of life enjoyment and satisfaction.Change in Q-LES-Q total score:total score at month 24 minus total score at randomization |
| Secondary | Change in Personal Evaluation of Transitions in Treatment (PETiT) Total Score | Randomization to Month 24 | PETiT total score is the sum of the 30 items of PETiT questionnaire(range:0-60) on subjects perceived well-being, adherence, tolerability, satisfaction with treatment. Each item is rated by participant with a 3 point frequency scale:2=often, 1=sometimes, 0=never.Change in PETiT total score: total score at month 24 minus total score at randomization |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Presence of a Cortical (C) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the Lens Opacities Classification System II (LOCS II ) Grading Scale | Randomization to Month 24 | The 2-year eye per protocol (E2PP) analysis included all randomized participants who met eye eligibility, had a valid baseline LOCS II evaluation, had reached the study endpoint of either a LOCS II identified cataractogenic potential event or dosed for 21 months without a LOCS II event, and had no major protocol deviations. | Participants with C type event | NUMBER |
| PRIMARY | Presence of a Nuclear Opalescence (N) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the LOCS II Grading Scale | Randomization to Month 24 | The 2-year eye per protocol (E2PP) analysis included all randomized participants who met eye eligibility, had a valid baseline LOCS II evaluation, had reached the study endpoint of either a LOCS II identified cataractogenic potential event or dosed for 21 months without a LOCS II event, and had no major protocol deviations. | Participants with N type event | NUMBER |
| PRIMARY | Presence of a Posterior Subcapsular (P) Type Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the LOCS II Grading Scale | Randomization to Month 24 | The 2-year eye per protocol (E2PP) analysis included all randomized participants who met eye eligibility, had a valid baseline LOCS II evaluation, had reached the study endpoint of either a LOCS II identified cataractogenic potential event or dosed for 21 months without a LOCS II event, and had no major protocol deviations. | Participants with P type event | NUMBER |
| SECONDARY | Change in the Positive and Negative Syndrome Scale (PANSS) Total Score | Randomization to Month 24 | The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication. | units on scale | MEAN |
| SECONDARY | Change in the PANSS Positive Subscale Score | Randomization to Month 24 | The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication. | units on scale | MEAN |
| SECONDARY | Change in the PANSS Negative Subscale Score | Randomization to Month 24 | The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication. | units on scale | MEAN |
| SECONDARY | Change in the PANSS Psychopathology Subscale Score | Randomization to Month 24 | The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication. | units on scale | MEAN |
| SECONDARY | Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score | Randomization to Month 24 | The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score (not related to CGI-S), and received at least 1 dose of study medication. | units on scale | MEAN |
| SECONDARY | Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q SF) Total Score | Randomization to Month 24 | The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication. | units on scale | MEAN |
| SECONDARY | Change in Personal Evaluation of Transitions in Treatment (PETiT) Total Score | Randomization to Month 24 | The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication. | units on scale | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Presence of a Cortical (C) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the Lens Opacities Classification System II (LOCS II ) Grading Scale | Quetiapine Fumarate | 2 | Participants with C type event | ||
Presence of a Cortical (C) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the Lens Opacities Classification System II (LOCS II ) Grading Scale | Risperidone | 8 | Participants with C type event | ||
| Presence of a Nuclear Opalescence (N) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the LOCS II Grading Scale | Quetiapine Fumarate | 0 | Participants with N type event | ||
| Presence of a Nuclear Opalescence (N) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the LOCS II Grading Scale | Risperidone | 2 | Participants with N type event | ||
| Presence of a Posterior Subcapsular (P) Type Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the LOCS II Grading Scale | Quetiapine Fumarate | 4 | Participants with P type event | ||
| Presence of a Posterior Subcapsular (P) Type Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the LOCS II Grading Scale | Risperidone | 7 | Participants with P type event | ||
| Change in the Positive and Negative Syndrome Scale (PANSS) Total Score | Quetiapine Fumarate | -9.1 | Standard Deviation 15.4 | units on scale | |
| Change in the Positive and Negative Syndrome Scale (PANSS) Total Score | Risperidone | -8.6 | Standard Deviation 16.6 | units on scale | |
| Change in the PANSS Positive Subscale Score | Quetiapine Fumarate | -2.7 | Standard Deviation 5.3 | units on scale | |
| Change in the PANSS Positive Subscale Score | Risperidone | -2.8 | Standard Deviation 5.1 | units on scale |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 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 | 596 | |
| Overall Study | STARTED | Risperidone | 502 | |
| Overall Study | COMPLETED | Quetiapine Fumarate | 188 | |
| Overall Study | COMPLETED | Risperidone | 187 | |
| Overall Study | NOT COMPLETED | Quetiapine Fumarate | 408 | |
| Overall Study | NOT COMPLETED | Risperidone | 315 |
Source ClinicalTrials.gov
Adverse events302
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 | Dry Mouth | Gastrointestinal disorders | Quetiapine Fumarate | 78 | 586 | |
| other | Dry Mouth | Gastrointestinal disorders | Risperidone | 39 | 496 | |
| other | Nausea | Gastrointestinal disorders | Quetiapine Fumarate | 47 | 586 | |
| other | Nausea | Gastrointestinal disorders | Risperidone | 43 | 496 | |
| other | Constipation | Gastrointestinal disorders | Quetiapine Fumarate | 45 | 586 | |
| other | Constipation | Gastrointestinal disorders | Risperidone | 28 | 496 | |
| other | Vomiting | Gastrointestinal disorders | Quetiapine Fumarate | 21 | 586 | |
| other | Vomiting | Gastrointestinal disorders | Risperidone | 36 | 496 | |
| other | Toothache | Gastrointestinal disorders | Quetiapine Fumarate | 38 | 586 | |
| other | Toothache | Gastrointestinal disorders | Risperidone | 17 | 496 |
1 to 10 of 302Source ClinicalTrials.gov
See all 302 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Quetiapine Fumarate | ||
| Total, all-cause mortality | Risperidone | ||
| Total, other adverse events | Quetiapine Fumarate | 476 | 596 |
| Total, other adverse events | Risperidone | 368 | 502 |
| Total, serious adverse events | Quetiapine Fumarate | 151 | 596 |
| Total, serious adverse events | Risperidone | 114 | 502 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Quetiapine Fumarate vs Risperidone: Number of Participants With Potential Extrapyramidal Symptoms (EPS) | Trial comparisons |
| Quetiapine Fumarate 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.
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/NCT00206102
GET https://conductscience.org/api/trials/v1/NCT00206102/results?page=2