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Mental Health

MRB - Closed

Managing Repetitive Behaviours Parent Group Study/ MRB Study - Managing Repetitive Behaviours: A clinical and cost effectiveness trial of a parent group intervention to manage restricted and repetitive behaviours in young children with Autism Spectrum Disorder

  • Study stage: Closed
  • Sponsor: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
  • Funder: NIHR HTA
  • Therapeutic area: Mental Health
  • Type of study: Non-clinical Intervention (behavioural intervention)

Aim: A multicentre randomised controlled trial of the MRB Intervention versus a Psychoeducation Parent Group (Learning About Autism; attentional control) in the management of restricted repetitive behaviours in young children with Autism Spectrum Disorder.

Primary Outcome: Clinical Global Impression - Improvement scale (CGI-I)
The improvement scores from the CGI-I will be taken from each randomised arm of the trial to inform the efficiency of the intervention. A cost per additional child achieving at least the target improvement in CGI-I scale will be calculated in each pathway.

  • Population: Adults and Paediatrics
  • Design: Randomised Control Trial (RCT)
  • Setting: Secondary Care
  • Planned Sample Size: 250 families

Website: https://research.ncl.ac.uk/mrbstudy/

PAX - BD - Closed

PAX-BD - A randomised, double-blind, placebo controlled trial of pramipexole in addition to mood stabilisers for patients with treatment resistant bipolar depression

  • Study stage: Closed
  • Sponsor: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
  • Funder: NIHR HTA
  • Therapeutic area: Mental Health
  • Type of study: CTIMP

Aim: The PAX-BD trial, is a multi-centre, randomised, placebo-controlled trial of pramipexole versus placebo. The aim is to elicit whether pramipexole, co-prescribed with mood stabilising medication (lithium, valproate, carbamazepine, lamotrigine), is an effective treatment for patients with Treatment Resistant Bipolar Depression.

Primary outcome: To evaluate the clinical effectiveness of pramipexole versus placebo alongside standard mood stabilising medication, over 12 weeks, in the management of patients with treatment resistant bipolar depression – collected via the Quick Inventory of DepressivGaste Symptomatology – Self Report (QIDS-SR) at 12 weeks, co-varying for score at 0 weeks.

  • Population: Adults
  • Clinical Phase: III
  • Design: Randomised Control Trial (RCT)
  • Setting: Secondary Care
  • Planned Sample Size: 290

Website: https://mood-disorders.co.uk/PAX-BD/

ASCEND - In Set-up

Aripiprazole/ sertraline combination: a non-inferiority design in comparison with quetiapine in bipolar depression.  An open label randomised controlled trial.

  • Study stage: Set-up
  • Sponsor: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
  • Funder: NIHR and Care Reserch.  Call: 19/130 Bipolar Disorder NIHR Health Technology Assessment Programme
  • Therapeutic area: Mental Health 
  • Type of study: CTIMP

Aim: To test the hypothesis that improvement in depression will be greater in participants randomised to aripiprazole/sertraline combination than those randomised to quetiapine.

Primary Outcome: The Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR) reported weekly, 12 to 16 weeks after randomisation in the two arms analysed as repeated measures, adjusted for baseline, using intention to treat principles.

  • Population: Adults
  • Design: RCT
  • Phase: III
  • Setting: Secondary Care
  • Planned Sample Size: 270
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