Trial record 11 of 12 for:    RO4917523

A Study of RO4917523 in Patients With Treatment Resistant Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00809562
First received: December 16, 2008
Last updated: September 18, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Depression
Drug: RO4917523
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety and tolerability: Adverse events, ECGs, laboratory parameters,vital signs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy: MADRS score [ Time Frame: From baseline to day 10 ] [ Designated as safety issue: No ]
  • Symptoms of treatment-resistant depression [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: March 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RO4917523
orally daily for 10 days, cohorts receiving up to 5 different doses (according to safety and tolerability)
Placebo Comparator: 2 Drug: Placebo
po daily for 10 days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809562

Locations
United States, California
Oceanside, California, United States, 92056
San Diego, California, United States, 92103
United States, Connecticut
New Haven, Connecticut, United States, 06511
United States, Louisiana
Shreveport, Louisiana, United States, 71115
United States, Mississippi
Flowood, Mississippi, United States, 39232
United States, New York
New York, New York, United States, 10032
New York, New York, United States, 10065-4870
New York, New York, United States, 10029
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00809562     History of Changes
Other Study ID Numbers: NP22022
Study First Received: December 16, 2008
Last Updated: September 18, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 21, 2014