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NCT00548327 · ClinicalTrials.gov registry record · Phase 2

The Effects of Atomoxetine on Cognition and Brain Function Based on Catechol-O-methyltransferase(COMT) Genotype

A Phase 2 study, sponsored by National Institute of Mental Health (NIMH).

Terminated
Registry status
Phase 2
Development phase
11
Enrollment target

NCT00548327: Clinical Trial Phase 2 study, sponsored by National Institute of Mental Health (NIMH).

NCT00548327 is a Phase 2 study that was terminated before completion, run by National Institute of Mental Health (NIMH). The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00548327, a Phase 2 study, was terminated before completion, sponsored by National Institute of Mental Health (NIMH).

TERMINATED
Registry status
Phase 2
Development phase
11 participants
Enrollment target

Study Summary

This study will evaluate whether Atomoxetine improves cognition in healthy volunteers as well as patients with schizophrenia. Atomoxetine is a drug that has been Food and Drug Administration (FDA) approved for Attention Deficit Disorder and allegedly increase the amount of the neurotransmitter dopamine in the frontal cortex of the brain.

Primary Outcome

Main outcome measures were BOLD fMRI response (activation) while performing a prefrontal cortex-dependent task such as N-Back Working Memory with increasing levels of task difficulty. It was expected to have a greater level of activation in BOLD fMRI in schizophrenic patients with respect to normal volunteers, and a greater activation in individuals (either normal volunteers or patients) who share the val/val genotype with respect to the met/met genotype. Based on prior fMRI studies and on powe

Interventions

  • DRUG Placebo
  • DRUG Atomoxetine
  • PROCEDURE Neuropsychological Testing
  • PROCEDURE Functional magnetic resonance imaging

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2007-10
Est. Completion 2011-11
Phase Phase 2

Why NCT00548327 stopped before completion

NCT00548327 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT00548327 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00548327 about?

NCT00548327 is a clinical study titled "The Effects of Atomoxetine on Cognition and Brain Function Based on Catechol-O-methyltransferase(COMT) Genotype". This study will evaluate whether Atomoxetine improves cognition in healthy volunteers as well as patients with schizophrenia. Atomoxetine is a drug that has been Food and Drug Administration (FDA) approved for Attention Deficit Disorder and allegedly increase the amount of the neurotransmitter dopam...

What is the current status of trial NCT00548327?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2007-10. Estimated completion is 2011-11.

What interventions are being tested in trial NCT00548327?

The interventions under investigation include: Placebo (DRUG), Atomoxetine (DRUG), Neuropsychological Testing (PROCEDURE), Functional magnetic resonance imaging (PROCEDURE).

Who is sponsoring clinical trial NCT00548327?

This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00548327's enrollment target sits among peer trials

11 1967th of 2000 higher than 33 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00548327, the US trial registry maintained by the National Library of Medicine. NCT00548327 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.