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Completed

NCT Number: NCT00809562

A Study of RO4917523 in Patients With Treatment Resistant Depression

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oceanside, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

po daily for 10 days

RO4917523

Drug

orally daily for 10 days, cohorts receiving up to 5 different doses (according to safety and tolerability)

Primary outcomes

  1. Safety and tolerability: Adverse events, ECGs, laboratory parameters,vital signs

    Time frame: Throughout study

Secondary outcomes

  1. Efficacy: MADRS score

    Time frame: From baseline to day 10

  2. Symptoms of treatment-resistant depression

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 17, 2008
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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