A Study of RO4917523 in Patients With Treatment Resistant Depression

Phase 2

Completed

• Conditions: Depression
• Interventions: Drug: RO4917523; Drug: Placebo

• Registration Number: NCT00809562
• Lead Sponsor: Hoffmann-La Roche

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-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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2008-12-16
• Study First Submitted QC: 2008-12-16
• Study First Posted: 2008-12-17
• Study Start: 2009-03
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2016-11
• Disposition First Submitted: 2016-11-01
• Disposition First Submitted QC: 2016-11-01
• Last Update Submitted: 2016-11-01
• Disposition First Posted: 2016-11-02
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	RO4917523	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability: Adverse events, ECGs, laboratory parameters,vital signs	Throughout study

Secondary Outcome Measures

Name	Time	Method
Efficacy: MADRS score	From baseline to day 10
Symptoms of treatment-resistant depression	Throughout study