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NCT00206102 · ClinicalTrials.gov registry record · Phase 4

A Study of the Cataractogenic Potential of Seroquel and Risperdal in the Treatment of Participants With Schizophrenia or Schizoaffective Disorder

A Phase 4 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 4
Development phase
1,098
Enrollment target

NCT00206102: Completed Phase 4 study, sponsored by AstraZeneca.

NCT00206102 is a Phase 4 study that has completed, run by AstraZeneca. The registered enrollment target is 1,098 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (112% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00206102, a Phase 4 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 4
Development phase
1,098 participants
Enrollment target

Study Summary

This Phase IV, randomized, parallel-group study is designed to evaluate the cataractogenic potential of quetiapine fumarate (SEROQUEL) compared with that of a putative non-cataractogenic antipsychotic medication risperidone (RISPERDAL). This study is being conducted to fulfill the SEROQUEL Phase IV commitment regarding evaluation of cataractogenic potential.

Primary Outcome

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.

Interventions

  • DRUG risperidone
  • DRUG quetiapine fumarate

Trial Details

FieldValue
Enrollment Target 1,098 participants
Start Date 2003-09
Est. Completion 2008-10
Phase Phase 4
AstraZeneca

1,285 total trials

What the finished NCT00206102 record still lists

NCT00206102 is an interventional study that assigns participants to a tested intervention. Its 1,098 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (112% higher).

The record links to 0 conditions, and to 2 interventions - of which risperidone is the first listed.

NCT00206102 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00206102 about?

NCT00206102 is a clinical study titled "A Study of the Cataractogenic Potential of Seroquel and Risperdal in the Treatment of Participants With Schizophrenia or Schizoaffective Disorder". This Phase IV, randomized, parallel-group study is designed to evaluate the cataractogenic potential of quetiapine fumarate (SEROQUEL) compared with that of a putative non-cataractogenic antipsychotic medication risperidone (RISPERDAL). This study is being conducted to fulfill the SEROQUEL Phase IV ...

What is the current status of trial NCT00206102?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,098 participants. The study started on 2003-09. Estimated completion is 2008-10.

What interventions are being tested in trial NCT00206102?

The interventions under investigation include: risperidone (DRUG), quetiapine fumarate (DRUG).

Who is sponsoring clinical trial NCT00206102?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00206102's enrollment target sits among peer trials

1,098 65th of 2000 higher than 1,936 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00206102, the US trial registry maintained by the National Library of Medicine. NCT00206102 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.