Home » Clinical Trials » Therapeutic Areas
Therapeutic Areas: Psychiatry/Psychology
Disease Category: Depression
Trial Information
A Study of RO4917523 in Patients With Treatment-Resistant Depression
Status: Recruiting
Protocol Number: NP22022
Sponsor: Hoffmann-La Roche
Company Division: Pharmaceutical
Official Scientific 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: This 3 arm 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, patients will be randomized to one of 3 treatment arms to receive RO4917523 0.1mg/day po or 0.5mg/day po, or placebo po daily. The anticipated time on study treatment is 10 days (in an inpatient unit), and the target sample size is <100 individuals.
Target sample size is
36
.
Study Phase: II
Study Design / Study Details:
- Purpose: Treatment
- Allocation: Randomized
- Masking: Double Blind
- Control: Placebo
- Assignment: Parallel
- Endpoints: Safety/Efficacy
Study Type:
Interventional
Condition: Depression
Intervention Type: Drug
Intervention Name: RO4917523
Primary Outcome: 1
.
Safety and tolerability: Adverse events, ECGs, laboratory parameters,vital signs
Time frame:
Throughout study
2
.
Efficacy: MADRS score
Time frame:
From baseline to day 10
Key Secondary Outcomes: 1. Symptoms of treatment-resistant depression Time frame: Throughout study
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.
Gender: Males or Females
Age Limits: Min: 18 Years Max: 65 Years
Accepts Healthy Volunteers: No
Anticipated Start Date: March, 2009
Trial Registration Date: 12/17/2008
Date Last Updated: 09/16/2009
Link To Trial Results
E-mail: genentechclinicaltrials@druginfo.com
Research Site:
Located In:
San Diego , CA 92105
Phone: 888-662-6728 (U.S. Only)
View Google Map
DISCLAIMER: This site is run by CenterWatch, a publishing company that focuses on the
clinical trials industry. The information provided in this service is designed
to help patients find clinical trials that may be of interest to them, and to
help patients contact the centers conducting the research. CenterWatch is
neither promoting this research nor involved in conducting any of these
trials.
