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NCT00512070 · ClinicalTrials.gov registry record · NA

Melatonin Metabolism Abnormality in Patients With Schizophrenia or Schizoaffective Disorder Treated With Olanzapine

A NA study, sponsored by Seattle Institute for Biomedical and Clinical Research.

Completed
Registry status
NA
Development phase
40
Enrollment target

NCT00512070: Completed NA study, sponsored by Seattle Institute for Biomedical and Clinical Research.

NCT00512070 is a NA study that has completed, run by Seattle Institute for Biomedical and Clinical Research. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00512070, a NA study, has completed, sponsored by Seattle Institute for Biomedical and Clinical Research.

COMPLETED
Registry status
NA
Development phase
40 participants
Enrollment target

Study Summary

Atypical antipsychotic medications, such as olanzapine, cause metabolic side effects, including weight gain, extra fat around the middle of the body, high blood sugar, and high cholesterol. One of the mechanisms by which these medications may cause these effects is by reducing plasma melatonin. This study is a pilot project to evaluate 1) the effect of olanzapine on melatonin secretion levels and 2) the effect of melatonin on olanzapine-induced changes in melatonin secretion in patients with schizophrenia, schizoaffective, or bipolar disorder.

Primary Outcome

Nocturnal melatonin production as estimated by assay of urinary 6-sulfatoxymelatonin (aMT6s) adjusted for creatinine

Interventions

  • DRUG olanzapine and melatonin

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2007-07
Est. Completion 2024-12
Phase NA

What the finished NCT00512070 record still lists

NCT00512070 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

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

NCT00512070 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00512070 about?

NCT00512070 is a clinical study titled "Melatonin Metabolism Abnormality in Patients With Schizophrenia or Schizoaffective Disorder Treated With Olanzapine". Atypical antipsychotic medications, such as olanzapine, cause metabolic side effects, including weight gain, extra fat around the middle of the body, high blood sugar, and high cholesterol. One of the mechanisms by which these medications may cause these effects is by reducing plasma melatonin. This...

What is the current status of trial NCT00512070?

This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2007-07. Estimated completion is 2024-12.

What interventions are being tested in trial NCT00512070?

The interventions under investigation include: olanzapine and melatonin (DRUG).

Who is sponsoring clinical trial NCT00512070?

This trial is sponsored by Seattle Institute for Biomedical and Clinical Research, which has 43 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00512070's enrollment target sits among peer trials

40 1447th of 2000 higher than 465 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT00512070, the US trial registry maintained by the National Library of Medicine. NCT00512070 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.