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Completed Phase 2 Interventional

A Study of RO4917523 in Patients With Treatment Resistant Depression

ClinicalTrials.gov ID: NCT00809562

Public ClinicalTrials.gov record NCT00809562. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 6:06 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Exploratory Fixed Dose Randomized Double Blind Parallel-group Placebo-controlled Study of the Safety and of the Therapeutic Effects of Ro 4917523 in Patients With Treatment- Resistant Depression

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study will evaluate the safety, tolerability and efficacy of RO4917523, in comparison to placebo, in patients with treatment-resistant depression. Following a washout period from existing anti-depressant medication, cohorts of patients will be randomized to receive daily oral RO4917523 at up to five different doses (according to the safety and tolerability observed at the lower doses during the study), or placebo. The anticipated time on study treatment is 10 days (in an inpatient unit), and the target sample size is \<100 individuals.

Study identification

NCT ID
NCT00809562
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
46 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 28, 2009
Primary completion
Jan 31, 2011
Completion
Jan 31, 2011
Last update posted
Nov 1, 2016

2009 – 2011

United States locations

U.S. sites
9
U.S. states
6
U.S. cities
7
Facility City State ZIP Site status
Not listed Oceanside California 92056
Not listed San Diego California 92103
Not listed New Haven Connecticut 06511
Not listed Shreveport Louisiana 71115
Not listed Flowood Mississippi 39232
Not listed New York New York 10029
Not listed New York New York 10032
Not listed New York New York 10065-4870
Not listed Pittsburgh Pennsylvania 15213

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00809562, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 1, 2016 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00809562 live on ClinicalTrials.gov.

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