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NCT00086593 · ClinicalTrials.gov registry record · Phase 3

Study Of An FDA-approved Drug As Additional Therapy In Patients With Schizophrenia

A Phase 3 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 3
Development phase
209
Enrollment target

NCT00086593: Completed Phase 3 study, sponsored by GlaxoSmithKline.

NCT00086593 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 209 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00086593, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
209 participants
Enrollment target

Study Summary

This is a 12-week study for the treatment of chronic persistent symptoms in participants with schizophrenia. Participants on a stable, optimal dose of up to two atypical antipsychotics who fulfill the screening criteria will be randomized to receive either an FDA-approved drug or placebo in addition to the current treatment. Safety will be closely monitored through vital signs, various tests, and blood and urine samples.

Interventions

  • DRUG lamotrigine

Trial Details

FieldValue
Enrollment Target 209 participants
Start Date 2004-05
Est. Completion 2005-07
Phase Phase 3
GlaxoSmithKline

1,345 total trials

What the finished NCT00086593 record still lists

NCT00086593 is an interventional study that assigns participants to a tested intervention. The registered 209 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower).

The record links to 0 conditions, and to 1 intervention - of which lamotrigine is the first listed.

NCT00086593 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00086593 about?

NCT00086593 is a clinical study titled "Study Of An FDA-approved Drug As Additional Therapy In Patients With Schizophrenia". This is a 12-week study for the treatment of chronic persistent symptoms in participants with schizophrenia. Participants on a stable, optimal dose of up to two atypical antipsychotics who fulfill the screening criteria will be randomized to receive either an FDA-approved drug or placebo in addition...

What is the current status of trial NCT00086593?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 209 participants. The study started on 2004-05. Estimated completion is 2005-07.

What interventions are being tested in trial NCT00086593?

The interventions under investigation include: lamotrigine (DRUG).

Who is sponsoring clinical trial NCT00086593?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00086593's enrollment target sits among peer trials

209 1345th of 2000 higher than 656 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00086593, the US trial registry maintained by the National Library of Medicine. NCT00086593 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.