Who is sponsoring NCT01191918?

NCT01191918 is sponsored by Shanghai Mental Health Center.

What condition does NCT01191918 study?

NCT01191918 studies Bipolar Disorder, Mania.

What drugs are being tested in NCT01191918?

Interventions: Donepezil and Lithium, Placebo plus Lithium.

What is the status of NCT01191918?

NCT01191918 is currently COMPLETED.

Last reviewed 2010-08-30 · How we verify

A Double-Blind, Placebo-Controlled Evaluation of The Efficacy and Safety of AChE Inhibitor Donepezil As Adjunctive Treatment to Mood Stabilizers in Acute Mania

NCT01191918 Phase 4 COMPLETED

There is a high rate of partial response to standard thymoleptic medication. In this study the investigators want to evaluate the safety and efficacy of donepezil as adjunctive treatment to mood stabilizers in bipolar disorder with acute mania. The investigators hypotheses were that there would be greater mean reduction in manic symptoms with donepezil augmentation of lithium compared with placebo.

Details

Lead sponsor	Shanghai Mental Health Center
Phase	Phase 4
Status	COMPLETED
Enrolment	40
Start date	2005-05
Completion	2008-04

Conditions

Bipolar Disorder
Mania

Interventions

Donepezil and Lithium
Placebo plus Lithium

Primary outcomes

Total score change of Young Mania Rating Scale — from baseline to week 4
Patients were assessed by outcomes assessores at 0 hour(h), 2h,4h,6h,8h,10h,12h,24h,1 week (w), 2w, 4w