A Study of RO4917523 in Patients With Treatment Resistant Depression

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00809562
• Other study ID #: NP22022
• Status: Completed
• Phase: Phase 2
• First received: December 16, 2008
• Last updated: November 1, 2016
• Start date: March 2009
• Est. completion date: February 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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-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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant

Intervention

Drug:
• Placebo
po daily for 10 days
• RO4917523
orally daily for 10 days, cohorts receiving up to 5 different doses (according to safety and tolerability)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability: Adverse events, ECGs, laboratory parameters,vital signs		Throughout study	No
Secondary	Efficacy: MADRS score		From baseline to day 10	No
Secondary	Symptoms of treatment-resistant depression		Throughout study	No