Efficacy of mifepristone in the treatment of bipolar depression

ISRCTN	ISRCTN27649427
DOI	https://doi.org/10.1186/ISRCTN27649427
Secondary identifying numbers	G0401207

Submission date: 22/06/2005
Registration date: 21/09/2005
Last edited: 09/09/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

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

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Efficacy of Mifepristone (RU-486) in the Treatment of Bipolar Depression, a randomised controlled trial
Study acronym	Deathstar
Study hypothesis	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
Condition	Bipolar Depression
Intervention	Adjunctive treatment with mifepristone (600 mg/day for 7 days) versus placebo
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Mifepristone
Primary outcome measure	1. Spatial Working Memory (CANTAB) 2. Verbal learning
Secondary outcome measures	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.
Overall study start date	01/05/2005
Overall study end date	30/06/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	100
Participant inclusion criteria	1. Bipolar Depression (Structured Clinical Interview for Depression [SCID]) 2. Age 18-65
Participant 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
Recruitment start date	01/05/2005
Recruitment end date	30/06/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

School of Neurology, Neurobiology & Psychiatry

Newcastle upon Tyne
NE1 4LP
United Kingdom

Sponsor information

The Newcastle, North Tyneside And Northumberland Mental Health NHS Trust (UK)
Hospital/treatment centre

Dr Roger Paxton
Research and Clinical Effectiveness
Modular Building
St Nicholas Hospital
Gosforth
Newcastle
NE3 3XT
England
United Kingdom

Phone	+44 (0)191 2232339
Email	gill.minto@nmht.nhs.uk
"ROR"	https://ror.org/01ajv0n48

Funders

Funder type

Research organisation

Stanley Medical Research Institute (UK) and Medical Research Council (MRC) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

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