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A Study of RO4917523 in Patients With Treatment Resistant Depression

NCT ID: NCT00809562

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

RO4917523

Intervention Type DRUG

orally daily for 10 days, cohorts receiving up to 5 different doses (according to safety and tolerability)

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

po daily for 10 days

Interventions

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Placebo

po daily for 10 days

Intervention Type DRUG

RO4917523

orally daily for 10 days, cohorts receiving up to 5 different doses (according to safety and tolerability)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, 18-65 years of age;
* recurrent major depressive disorder, without psychotic features;
* at least 3 lifetime treatment failures, at least 2 of which must have occurred within the current depressive episode;
* baseline minimal severity defined by a HAM-D score of 18 or above;
* willing to be hospitalized for at least 16 consecutive days.

Exclusion Criteria

* history of bipolar disorder, schizoaffective disorder or schizophrenia;
* history of psychosis, including psychotic depression;
* significant past or present neurological disorder, including seizures, stroke and/or head trauma.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Oceanside, California, United States

Site Status

San Diego, California, United States

Site Status

New Haven, Connecticut, United States

Site Status

Shreveport, Louisiana, United States

Site Status

Flowood, Mississippi, United States

Site Status

New York, New York, United States

Site Status

New York, New York, United States

Site Status

New York, New York, United States

Site Status

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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NP22022

Identifier Type: -

Identifier Source: org_study_id