Status:

COMPLETED

A Study of RO4917523 in Patients With Treatment Resistant Depression

Lead Sponsor:

Hoffmann-La Roche

Conditions:

Depression

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

Brief Summary

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-de...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

March 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2011

Estimated Enrollment :

46 Patients enrolled

Trial Details

Trial ID

NCT00809562

Start Date

March 1 2009

End Date

February 1 2011

Last Update

November 2 2016

Active Locations (9)

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Page 1 of 3 (9 locations)

1

Oceanside, California, United States, 92056

2

San Diego, California, United States, 92103

3

New Haven, Connecticut, United States, 06511

4

Shreveport, Louisiana, United States, 71115