Conditions: Fibromyalgia
Keywords: Milnacipran Duloxetine Switch Forest Research Institute
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 107
Healthy volunteers: no

Brief summary:
The objective of this study is to evaluate the safety, tolerability and efficacy of milnacipran in patients with an inadequate response to duloxetine for the treatment of fibromyalgia.

Detailed description:
* Two weeks Duloxetine 60 mg Open-Label Period
* Randomization to Double-Blind Treatment Period: 10 weeks Milnacipran (direct switch) or 10 weeks placebo (one week blinded 30 mg duloxetine)
* One week Double-Blind Down-Taper Period

Arms:
arm 1: Placebo tablets, twice a day, oral administration arm 2: Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses.

Interventions: intervention 1: Placebo intervention 2: Milnacipran
Intervention descriptions: intervention 1: * Placebo tablets, oral administration, twice daily for 10 weeks during randomized, double-blind treatment period. Duloxetine capsules, oral administration, 30 mg/day for 1 week after randomization to effect a duloxetine down-taper.
* Placebo tablets, twice daily for 1 week during double-blind down-taper treatment period. intervention 2: * Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses for 10 weeks during randomized, double-blind treatment period. Placebo capsules, 1 capsule/day administered for 1 week after randomization to maintain double-blind duloxetine down-taper.
* Milnacipran tablets, 100 to 0 mg/day, oral administration, twice daily in divided doses for 1 week during double-blind down-taper treatment period.

Protocol document: