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NCT00401973 · ClinicalTrials.gov registry record · Phase 3

Assessment of Safety and Efficacy of Therapy for the Prevention of Weight Gain Associated With Olanzapine

A Phase 3 study, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 3
Development phase
199
Enrollment target

NCT00401973: Completed Phase 3 study, sponsored by Eli Lilly and Company.

NCT00401973 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 199 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00401973, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 3
Development phase
199 participants
Enrollment target

Study Summary

The goal of this study is to answer the following questions: * Whether treatment with amantadine, metformin or zonisamide can prevent or reverse the weight gain that is associated with olanzapine * Whether taking amantadine, metformin or zonisamide can help patients decrease or eliminate some of the changes in body that occur with weight gain * How weight gain associated with olanzapine can affect people * Whether treatment with amantadine, metformin or zonisamide can help eliminate weight gain associated with olanzapine and not interfere with the positive effects of olanzapine on functioning of people with schizophrenia and other diseases

Interventions

  • DRUG metformin
  • DRUG olanzapine
  • DRUG zonisamide
  • DRUG amantadine
  • BEHAVIORAL Wellness education

Trial Details

FieldValue
Enrollment Target 199 participants
Start Date 2006-11
Est. Completion 2008-09
Phase Phase 3
Eli Lilly and Company

1,341 total trials

What the finished NCT00401973 record still lists

NCT00401973 is an interventional study that assigns participants to a tested intervention. The registered 199 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 (74% lower).

The record links to 0 conditions, and to 5 interventions - of which metformin is the first listed.

NCT00401973 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00401973 about?

NCT00401973 is a clinical study titled "Assessment of Safety and Efficacy of Therapy for the Prevention of Weight Gain Associated With Olanzapine". The goal of this study is to answer the following questions: * Whether treatment with amantadine, metformin or zonisamide can prevent or reverse the weight gain that is associated with olanzapine * Whether taking amantadine, metformin or zonisamide can help patients decrease or eliminate some of th...

What is the current status of trial NCT00401973?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 199 participants. The study started on 2006-11. Estimated completion is 2008-09.

What interventions are being tested in trial NCT00401973?

The interventions under investigation include: metformin (DRUG), olanzapine (DRUG), zonisamide (DRUG), amantadine (DRUG), Wellness education (BEHAVIORAL).

Who is sponsoring clinical trial NCT00401973?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00401973's enrollment target sits among peer trials

199 1388th of 2000 higher than 612 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 NCT00401973, the US trial registry maintained by the National Library of Medicine. NCT00401973 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.