Condition category
Mental and Behavioural Disorders
Date applied
22/06/2005
Date assigned
21/09/2005
Last edited
09/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof IN Ferrier

ORCID ID

Contact details

School of Neurology
Neurobiology & Psychiatry
Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
+44 (0)191 282 4336
i.n.ferrier@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0401207

Study information

Scientific title

Efficacy of Mifepristone (RU-486) in the Treatment of Bipolar Depression, a randomised controlled trial

Acronym

Deathstar

Study hypothesis

Adjunctive treatment with mifepristone will improve neuropsychological performance and ameliorate depressive symptoms in patients with bipolar depression

Ethics approval

Added 09/09/09: Newcastle and North Tyneside 1, approved 06/09/2004, ref 04/Q0905/110

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Bipolar Depression

Intervention

Adjunctive treatment with mifepristone (600 mg/day for 7 days) versus placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Mifepristone

Primary outcome measures

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 trial start date

01/05/2005

Overall trial end date

30/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Bipolar Depression (Structured Clinical Interview for Depression [SCID])
2. Age 18-65

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

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

United Kingdom

Trial participating centre

School of Neurology, Neurobiology & Psychiatry
Newcastle upon Tyne
NE1 4LP
United Kingdom

Sponsor information

Organisation

The Newcastle, North Tyneside And Northumberland Mental Health NHS Trust (UK)

Sponsor details

Dr Roger Paxton
Research and Clinical Effectiveness
Modular Building
St Nicholas Hospital
Gosforth
Newcastle
NE3 3XT
United Kingdom
+44 (0)191 2232339
gill.minto@nmht.nhs.uk

Sponsor type

Government

Website

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 interim results:
Efficacy of Mifepristone (RU-486) in the Treatment of Bipolar Depression
Author(s): Watson, S; Gallagher, P; Porter, RJ, et al.
Conference Information: 64th Annual Convention of the Society-of-Biological-Psychiatry, May 2009 - Vancouver, Canada. BIOLOGICAL PSYCHIATRY Volume: 65 Issue: 8 Pages: 135S-136S. Published in 2009. Meeting abstract: 448.

Publication citations

Additional files

Editorial Notes