NCT01541605

Methylphenidate for the Treatment of Acute Mania

International Randomised Double-blind Placebo-controlled Study on the Initial Treatment of Acute Mania With Methylphenidate

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Michael Kluge · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims at evaluating the efficacy and safety of methylphenidate in the initial treatment of acute mania in patients with bipolar affective disorders.

Detailed description

Mania can be regarded as an autoregulatory mechanism to enhance unstable vigilance. There is increasing evidence that psychostimulants that increase vigilance may be effective in treating mania. However, controlled studies are lacking. This is a two-arm, randomised, placebo-controlled, double-blind, parallel, multi-centre phase IIIb exploratory study to evaluate the efficacy and safety of methylphenidate in the initial treatment of acute mania in patients with bipolar affective disorders.

Conditions

• Mania

Interventions

Type	Name	Description
DRUG	methylphenidate	tablets for oral use
DRUG	Placebo	tablets for oral use

Timeline

• Start date: 2012-03-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2012-03-01
• Last updated: 2016-06-10

Locations

10 sites across 4 countries: Belgium, Germany, Hungary, Spain