Efficacy of mifepristone in the treatment of bipolar depression

ISRCTN	ISRCTN27649427
DOI	https://doi.org/10.1186/ISRCTN27649427
Protocol serial number	G0401207
Sponsor	The Newcastle, North Tyneside And Northumberland Mental Health NHS Trust (UK)
Funder	Stanley Medical Research Institute (UK) and Medical Research Council (MRC) (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof IN Ferrier
Scientific

School of Neurology, Neurobiology & Psychiatry
Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Phone	+44 (0)191 282 4336
Email	i.n.ferrier@ncl.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Efficacy of Mifepristone (RU-486) in the Treatment of Bipolar Depression, a randomised controlled trial
Study acronym	Deathstar
Study objectives	Adjunctive treatment with mifepristone will improve neuropsychological performance and ameliorate depressive symptoms in patients with bipolar depression
Ethics approval(s)	Added 09/09/09: Newcastle and North Tyneside 1, approved 06/09/2004, ref 04/Q0905/110
Health condition(s) or problem(s) studied	Bipolar Depression
Intervention	Adjunctive treatment with mifepristone (600 mg/day for 7 days) versus placebo
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Mifepristone
Primary outcome measure(s)	1. Spatial Working Memory (CANTAB) 2. Verbal learning
Key secondary outcome measure(s)	A secondary neuropsychological battery will also be included which examines a broader range of neurocognitive domains, incorporating: short-term memory span, visuo-spatial learning and memory, executive function, attention, semantic memory and perception of facial expression of emotion. In addition, depressive symptoms measured with the Montgomery and Asberg Depression Rating Scale (MADRS) will also act as secondary outcome measure.
Completion date	30/06/2010

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	100
Key inclusion criteria	1. Bipolar Depression (Structured Clinical Interview for Depression [SCID]) 2. Age 18-65
Key exclusion criteria	1. SCID diagnosis of mixed episode 2. Change in medication over the past 4 weeks 3. History of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) 4. Alcohol dependence (within the last 12 months) 5. Current alcohol or substance abuse (within the last month) 6. Previous head-injury associated with loss of consciousness 7. Pregnant 8. Intending to become pregnant 9. Women not using adequate contraception 10. Neurological disorder 11. Endocrine disorder other than corrected hypothyroidism 12. Steroid medication 13. Significant physical health problem 14. Contraindication to study drug
Date of first enrolment	01/05/2005
Date of final enrolment	30/06/2010

School of Neurology, Neurobiology & Psychiatry

Newcastle upon Tyne
NE1 4LP
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	12/01/2012		Yes	No
Abstract results	abs 448	15/04/2009		No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes