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NCT00616798 · ClinicalTrials.gov registry record · Phase 2

A Study of RO4917838 in Combination With Antipsychotic Treatment in Patients With Schizophrenia.

A Phase 2 study of Schizophrenia, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 2
Development phase
323
Enrollment target
20
Study locations

NCT00616798 is a Phase 2 study of Schizophrenia that has completed, run by Hoffmann-La Roche. The registered enrollment target is 323 participants, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (48% higher). The trial reports 20 study locations across 9 states.

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The verdict

NCT00616798, a Phase 2 study of Schizophrenia, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 2
Development phase
323 participants
Enrollment target
20
Study locations

Study Summary

This study will determine the efficacy and safety of RO4917838 in patients with schizophrenia who are stable on current antipsychotic treatment (olanzapine, que tiapine, risperidone, paliperidone or aripiprazole) with prominent negative or d isorganized thought symptoms. After a 4 week run in period on their current anti psychotic treatment, patients will be randomized to receive placebo 10mg, 30mg, or 60mg of RO4917838 once daily, p.o., as add-on therapy. The anticipated time o n study treatment is \<3 months, and the target sample size is 100-500 individual s.

Conditions Studied

Schizophrenia

Interventions

  • DRUG Placebo
  • DRUG RO4917838
  • DRUG Standard antipsychotic therapy

Study Locations (20)

Other

  • - Vienna
  • - Vienna
  • - Curitiba
  • - Pelotas
  • - Rio de Janeiro
  • - Salvador

California

  • - Granada Hills
  • - Los Angeles
  • - Oceanside
  • - Torrance

Texas

  • - Austin
  • - Austin
  • - DeSoto
  • - Irving

Georgia

  • - Atlanta

Illinois

  • - Hoffman Estates

New York

  • - Brooklyn

Ohio

  • - Cincinnati

Oklahoma

  • - Oklahoma City

Trial Details

FieldValue
Enrollment Target 323 participants
Start Date 2008-03
Est. Completion 2010-02
Phase Phase 2

Sponsor

Hoffmann-La Roche

909 total trials

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What the Registry Record Tells You About NCT00616798

The ClinicalTrials.gov registry entry for NCT00616798 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 323 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (48% higher). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT00616798 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, California, Texas.

Frequently Asked Questions

What is clinical trial NCT00616798 about?

NCT00616798 is a clinical study titled "A Study of RO4917838 in Combination With Antipsychotic Treatment in Patients With Schizophrenia.". This study will determine the efficacy and safety of RO4917838 in patients with schizophrenia who are stable on current antipsychotic treatment (olanzapine, que tiapine, risperidone, paliperidone or aripiprazole) with prominent negative or d isorganized thought symptoms. After a 4 week run in period...

What is the current status of trial NCT00616798?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 323 participants. The study started on 2008-03. Estimated completion is 2010-02.

What conditions does trial NCT00616798 study?

This clinical trial studies the following conditions: Schizophrenia.

What interventions are being tested in trial NCT00616798?

The interventions under investigation include: Placebo (DRUG), RO4917838 (DRUG), Standard antipsychotic therapy (DRUG).

Who is sponsoring clinical trial NCT00616798?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00616798 being conducted?

This trial has 20 study locations across California, Georgia, Illinois, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.