Trial information
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 type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
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:
- male or female outpatients, 18-60 years of age (plus a pilot group >60 years of age);
- moderate or serious major depression;
- HAMD score >=18 after 6+ weeks SSRI treatment;
- DSM-IV criteria for major depression.
Exclusion criteria:
- non-response to anti-depressant treatments;
- past treatment with Ixel;
- treatment with MAOIs in previous 3 weeks, and treatment with other anti-depressants in previous week;
- chronic use of minor tranquillisers or hypnotic drugs during last 2 months.
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: 10/15/2008
Link to trial result
This trial was conducted at the following locations:
Brazil
- Botucatu
- Porto Alegre
- Santo Andre
- Sao Paulo
