Bipolar Depression Mental and Behavioural Disorders Bipolar depression
Conditions
Interventions
Adjunctive treatment with mifepristone (600 mg/day for 7 days) versus placebo
Sponsors
The Newcastle, North Tyneside And Northumberland Mental Health NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Bipolar Depression (Structured Clinical Interview for Depression [SCID]) 2. Age 18-65
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Spatial Working Memory (CANTAB) 2. Verbal learning | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed