Current Research Studies

CCP-UK: Clinical Characterisation Protocol



Current Studies




Antidepressant for the prevention of DEPression following first episode Psychosis trial (ADEPP)

  • Diagnosis of first episode psychosis (FEP) Within 12 months of initial treatment for FEP
  • Positive and Negative Syndrome Scale (PANSS) individual positive item scores all ≤4
  • Sufficiently recovered from acute psychotic episode with capacity to consent
  • Male and females aged 18-65 years
  • Currently prescribed antipsychotic medication at a stable dose


  • Current moderate or severe depression as indicated by a Calgary Depression for Schizophrenia Scale (CDSS) score >7
  •  Currently prescribed antidepressant medication (or within 2 weeks of stopping if previously prescribed a monoamine oxidase inhibitor)
  •  Previous history of mania
  • Contraindications to SSRI antidepressant treatment.
  • Serious medical or neurological illness
  • Concomitant treatment with irreversible monoamine oxidase inhibitors (MAOIs)
  • Patient with any other systemic dysfunction




A multicentre double-blind placebo-controlled randomised trial of SerTRaline for AnxieTy in adults with a diagnosis of Autism (STRATA)

  • Adults (≥18-years)
  • A diagnosis of autism made by a specialist including those with a co-occurring mild intellectual disability
  • A diagnosis of anxiety as measured by GAD-7 score ≥10 at screening
  • Prescribed a serotonergic antidepressant/anxiolytic in preceding 8-weeks.
  • Prescribed an irreversible monoamine oxidase inhibitor or Pimozide in the preceding 8-weeks.
  • Inability to provide informed consent and complete study assessments / questionnaires.
  • History of bipolar disorder, manic or hypomanic episodes, or psychosis


ASSURED assured supporting people who self-harm

Improving outcomes in patients who self-harm - Adapting and evaluating a brief pSychological inteRvention in Emergency Departments (ASsuRED).

  • ≥16 years of age
  • presenting to the ED
  • Presenting with self-harm
  • on presenting to the ED, can be admitted for a brief admission to the acute hospital or a brief crisis admission
  • provide informed consent to take part


  • A current or previous participant of the Assured study
  • Patients with cognitive (e.g. dementia) or other psychiatric difficulties interfering with ability to participate
  • Experiencing a psychotic episode
  • No capacity to provide written informed consent
  • Needing an interpreter



Trauma Aid  trauma aid

Eye movement desensitisation and reprocessing for

symptoms of post-traumatic stress disorder in adults

with intellectual disabilities

Service Users

  • Aged ≥ 18 to ≤ 65
  • Meeting criteria for a diagnosis of ID
  • Meeting ICD-11 diagnostic criteria for PTSD
  • Major identified trauma at least a year earlier
  • Able to communicate in English
  • Able to provide informed consent


  • Aged ≥ 18 and over
  • A family member or carer of a person with ID who has
  • Consented to participate in the trial
  • Able to communicate in English
  • Assessed by the clinical team as at high risk and/or requiring urgent treatment
  • Currently in therapy and unwilling to intermit
  • Previously completed a course of EMDR
  • Psychosis not well controlled by medication
  • Change of psychotropic medication or dosage within the last month
  • Unable to complete the assessments




Genetic links to GLAD anxiety & depression

NIHR Mental Health BioResource for Depression and Anxiety /

Genetic Links to Anxiety and Depression (GLAD)

  • Participants who have been diagnosed with and/or treated for depression or anxiety.
  • Participants who are aged 16 or over.





Trial of Ondansetron as a Parkinson’s HAllucinations Treatment

  • Adults aged over 18 years
  • Meet MDS criteria for PD or Revised Criteria for DLB.
  • Score of 3 or more on the SAPS-H visual hallucinations item, indicating the presence of visual hallucinations at least weekly in the previous month.
  • Score of 3 or more on SAPS-H global rating, indicating moderate symptom severity.
  • Score of 4 or more on CGI-S, indicating moderate symptom severity.
  • On a stable dose of anti-Parkinson’s medication, cholinesterase inhibitor or memantine for at least 28 days.
  • Capacity to give informed consent or, if lacking, legal representative able to give consent.
  • If treated with an antipsychotic drug at the time of enrolment, can still participate, provided the drug is stopped the day before trial medication is commenced
  • Women of childbearing potential have a negative urine pregnancy test within 7 days prior to being registered/randomised.
  • Pre-menopausal women, and men whose partners are of child-bearing potential will agree to use effective contraception.
  • Sufficient knowledge of the English language to be able understand the participant information sheet and trial materials including outcome assessments.
  • Bradycardia (<50 bpm) (rescreen if reversible).
  • Congenital long QTc syndrome or presence of clinically significant prolongation of QTc (>460 ms for men or >470 ms for women) on ECG screening.
  • Hepatic failure (bilirubin > 26umol/l (1.5x upper limit of normal), and/or ALT or AST > 2.5 upper limit of normal
  • Prescribed apomorphine (if apomorphine is discontinued, rescreen once stable on an alternative anti-Parkinson’s treatment).
  • Currently prescribed ondansetron or other setrons (tropisetron, granisetron, dolasetron)
  • History of hypersensitivity to ondansetron or its excipients (or those of placebo) or other setrons listed in 5).
  • Participation in another Clinical Trial of an Investigational Medicinal Product (IMP) in the previous 28 days




Long COVID Personalised self-management support evaluation

Participants will be eligible if they experience persistent illness (at least one long Covid symptom for 12 weeks or longer) AND meet any one of the following criteria:

  • Positive SARS-CoV-2 PCR or antigen test (positive Covid-19 test) during the acute phase of illness
  • Positive SARS-CoV-2 antibody test (positive Covid-19 antibody test) at any time point in the absence of SARS-CoV-2 (Covid-19) vaccination history
  • Loss of sense of smell or taste during the acute phase in the absence of any other identified cause
  • Symptoms consistent with SARS-CoV-2 (Covid-19) infection during the acute phase and high prevalence of Covid-19 at time and location of onset
  • At least one symptom consistent with SARS-CoV-2 (Covid-19) infection during the acute phase AND close contact of a confirmed case of Covid-19 around the time of onset
  • They will be aged 18 years or above and be an English or Welsh speaker or have access to someone who can act as a translator.
  • They must have consulted with their GP to rule out serious complications or the need for further investigation in relation to persistent symptoms following Covid-19 infection.
  • Participants will not be eligible if they have any co-morbidities which are progressive or requiring palliative treatment or have been hospitalised for treatment of Covid-19 symptoms, during the acute phase of Covid illness, or are currently participating in any Covid intervention trial (including contributing to the LISTEN co-design activities).





A multicentre randomised controlled trial of guided self-help versus treatment as usual for depression for autistic adults

  • Adults aged ≥18-years.
  •  A clinical diagnosis of Autism Spectrum Disorder (ASD)
  • Current depression measured by the PHQ-9 with a score of ≥ 10 at screening
  • Can be on medication but dose should be stable for 6 weeks prior to randomisation


  • Risk of suicide
  • Have attended > 6 sessions of individual psychological treatment within a CBT framework over the past 6 months
  • A history of psychosis
  • Current alcohol/substance dependence
  • Untreated epilepsy
  • English, non-English & Welsh literacy levels such that the treatment materials are inaccessible without reasonable adjustments and a supporting person is not available




Recovery Colleges Characterisation and Testing 2 (RECOLLECT 2): Exploring the impact of Recovery Colleges on Student Outcomes and factors which affect these (Studies 1-3)

All Recovery Colleges

  • A focus on supporting personal recovery
  • An aspiration to use co-production, defined as individuals with lived experience working with staff or subject experts to design and deliver all aspects of the Recovery College
  • An aspiration to use adult learning approaches, in which students and trainers collaborate and learn from each other by sharing experiences, knowledge, and skills
  • Location in England
  • Agree to participate

Student participants

  • Aged 18 or over
  • Capacity to give informed consent
  • Currently using the local secondary NHS mental health service
  • Newly enrolled at a participating Recovery College (i.e., has done a maximum of 1 class or workshop)

Staff participants

  • Aged 18 or over
  • Capacity to give informed consent
  • Recovery College staff whether on substantive, sessional, casual and voluntary contracts (e.g., peer trainers, non-peer trainers, college manager)

All Recovery Colleges

  • Do not meet the inclusion criteria

Student participants

  • Not currently using the local secondary NHS mental health service