Trial Information

Summary: A Study of Ixel (Milnacipran) in Patients With Major Depression Not Responding to SSRIs.

Status: Completed

Protocol Number: ML17259

Sponsor: F Hoffman-La Roche Ltd

Company Division: Pharmaceutical

Official Scientific Title: An open-label study of the effect of milnacipran on depression scores in patients with major depression not responding to SSRI treatment.

Brief Summary: This study will assess the efficacy and safety of Ixel in outpatients aged 18-60 with moderate or severe depression not responding to adequate treatment with SSRIs. Patients will receive 6 weeks treatment with an SSRI, followed by 1-2 weeks washout. Eligible patients will then receive 12 weeks treatment with Ixel, 25mg bid in the first week, followed by 50mg bid from week 2 onwards. Increase in dose up to 200mg daily will be at the investigator's discretion, after week 4. A pilot group of elderly patients (aged over 60 years) will also be included in the study, and will receive escalating doses of Ixel not exceeding 100mg daily. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 94.

Study Phase: IV

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Non-Randomized
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Single Group
• Endpoints: Safety/Efficacy

Study Type:

Condition: Depression Disorder, Major

Intervention Type: Drug

Intervention Name: milnacipran[Ixel]

Primary Outcome: 1. Depression scores (HAM-D, CGI, Fawcett-Clark pleasure scale) plus MADRS and CAMCOG scales in elderly group

Key Secondary Outcomes: 1. AEs; weight; sexual dysfunction questionnaire; WHOQOL questionnaire.

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 60 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 06/16/2006

Date Last Updated: 04/16/2008

Link To Trial Results

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.

Trial listings updated: May 13, 2008 at 2:37:25 PM