BRIGHT Study: Brain circuits underlying cognition
Overview
During previous studies, we have identified a short battery of cognitive tasks that can identify differences in the way people with and without Psychosis and Major Depressive Disorder (MDD) use cognitive processes that are vital for sustaining attention, monitoring information and selecting behaviours to attain a goal. We use these skills every day to learn, work, and manage daily life.
This study has two parts. The purpose of the first part of this study is to use different brain imaging techniques (Magnetic Resonance Imaging (MRI) and Electroencephalography (EEG) scans) to see how carrying out these tasks affects activity in the brain. The second part will use EEG and MRI to look at the effect that sleep quality has on memory, learning and performance of the cognitive tasks.
What will it involve?
You will be invited to take part in two pre-screening calls and if you appear to be suitable, you will complete some online assessments at home and then come for a screening visit at the Clinical Research Facility (CRF) at Kings College Hospital (KCH), Denmark Hill, London.
The first part of the study requires you to make two visits to the CRF at KCH. During one of these visits, you will have MRI and EEG scanning sessions and in the other, you will complete some cognitive assessments and answer questions about your psychiatric history and symptoms. Each visit will last about 5 hours.
The second part involves wearing an activity watch for 7 days before staying overnight in the CRF for two consecutive nights to measure sleep and activity. You will come to the CRF during the afternoon before the first night and will go home at the end of the day after the second night. During both nights you will have EEG recorded whilst sleeping and during each following day you will have an MRI scan and complete cognitive assessments.
You can decide if you want to take part in the second part of the study once you have completed part one.
If you take part in the first part of the study only, you will be in the study for about 2 weeks. If you take part in both parts, you will be in the study for between 3 and 6 weeks.
Who are we looking to recruit?
We are looking for 3 groups of people, aged between 18 and 55:
- People experiencing Psychosis (e.g., Schizophrenia)
- People with MDD who are currently experiencing depressive symptoms
- People with no mental or physical health issues
Reimbursements and expenses
We appreciate the time you will have to give up to take part, and so will compensate you for your time.
If you complete part one of the study you will receive £350.
If you complete part two of the study you will receive an additional £930.
We will reimburse reasonable travel expenses or we can pay for a taxi to bring you to and from the clinic visits.
Are you interested in taking part in this study?
Planned end date
31 Aug 2027 13:07Conditions
Depression,SchizophreniaInclusion Criteria
All participants must:
1. Be able to provide signed and dated informed consent for study participation.
2. Be male or female, aged between 18 and 55 years, inclusive.
3. Be right-handed.
4. Have acceptable auditory acuity, corrected by hearing aids if necessary.
5. Have 20/20 vision corrected by glasses or contact lenses if necessary.
In addition to the 5 criteria above, MDD participants must fulfil the following:
6. Have a primary Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) diagnosis of MDD, confirmed by the result of the Mini-International Neuropsychiatric Interview (MINI) interview at pre-screening. Subjects with a diagnosis of comorbid Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), Panic Disorder or specific phobia may be included.
7. Meet the DSM-5 criteria for a current Major Depressive Episode, with the current depressive episode not having lasted longer than 2 years.
8. If undergoing treatment, be currently treated with a single antidepressant at a dose not exceeding licensing guidelines. Psychological treatments (e.g., Cognitive Behaviour Therapy, Interpersonal Psychotherapy, Psychodynamic Psychotherapy, etc.) are all permitted in this study. Psychological treatments should not have commenced in the 4 weeks before the start of the study.
In addition to the first 5 criteria, SZ participants must:
6. Have a primary diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5), confirmed by the result of the MINI interview conducted at pre-screening. Subjects diagnosed with unspecified schizophrenia spectrum and other psychotic disorder may be included if, according to the judgement of the clinician, a primary diagnosis of schizophrenia is likely but available information to make the specific diagnosis is inadequate or insufficient. Subjects with a diagnosis of comorbid Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), Panic Disorder or specific phobia may be included.
7. Have a duration of illness not exceeding 10 years from their first diagnosis of psychosis as assessed by their clinical records and be clinically stable (in the investigator's opinion) and in the non-acute phase of their illness.
8. Unless otherwise stated, CNS medications to treat symptoms of SZ and other stable CNS conditions requiring medication are permitted, provided the daily dose is not expected to change while participating in the study. Current treatment with antipsychotic medication must be be at a dose not exceeding licensing guidelines. Psychological treatments (e.g., Cognitive Behaviour Therapy, Interpersonal Psychotherapy, Psychodynamic Psychotherapy, etc.) are all permitted in this study. Psychological treatments should not be commenced or change modality during the study.
Exclusion Criteria
All participants must not:
1. If female, be pregnant.
2. Have any MR contra-indications (e.g., metal implants, pacemakers, claustrophobia etc.) which would render them unsuitable for the study.
3. Have a history of substance use disorder according to DSM-5 criteria, except nicotine or caffeine, within 6 months before screening.
4. Have a diagnosis of any clinically significant neurological disease or mental disorder according to judgement of the investigator (e.g., multiple sclerosis, epilepsy, dementia and autism).
5. Have a history of severe learning disability accordingly to the judgement of the investigator.
6. Have a sleep disorder diagnosis other than insomnia (e.g., sleep apnoea, restless leg syndrome, parasomnias).
7. Have had major surgery (e.g., requiring local or general anaesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or have surgery planned during the time they are expected to participate in the study.
8. Have a current serious or unstable clinically important systemic illness (e.g., hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrinologic, immunologic, hematologic, or ocular disorders, insulin-dependent diabetes, diagnosis of cancer in the previous 6 months) that in the judgement of the investigator may affect their ability to complete the study assessment.
9. Are, in the opinion of the investigator, likely to present a danger to themselves or others.
10. Have regularly used any of the restricted or prohibited medication or treatment listed in the table in section 8.5 Concomitant medication and treatments.
11. Have used cannabis in the 12 hours before cognitive testing.
12. Have worked night shifts and/or have had transmeridian travel during the 2 weeks prior the EEG recordings.
13. Are employees of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of the investigator as well as family members of the employees or the investigator.
14. Are, in the opinion of the investigator, unlikely to comply with the protocol or are unsuitable for any reason.
In addition to the 14 criteria above, MDD participants must not:
15. Also have a diagnosis of:
a. Bipolar Disorder (BD)
b. Any Eating Disorder, such as Anorexia or Bulimia Nervosa
c. Obsessive Compulsive Disorder (OCD)
d. Post-traumatic Stress Disorder (PTSD)
e. ADHD/Autism Spectrum Disorder (ASD)
Subjects with comorbid GAD, SAD, panic disorder or specific phobias are not excluded.
16. Be currently treated with an antipsychotic.
17. Have been treated with ECT in the three months prior screening.
In addition to the first 14 criteria, SZ participants must not:
15. Also have a diagnosis of:
a. Bipolar Disorder (BD)
b. Any Eating Disorder, such as Anorexia or Bulimia Nervosa
c. Obsessive Compulsive Disorder (OCD)
d. Post-traumatic Stress Disorder (PTSD)
e. ADHD/ASD
Subjects with comorbid GAD, SAD, panic disorder or specific phobias are not excluded.
16. Have a score >3 (mild) in Clinical Global Impression of Parkinsonism as measured by the ESRS-A at screening.
In addition to the first 14 criteria, healthy control participants must not:
15. Currently, or have ever, had one or more of the following diagnoses according to the Statistical Manual of Mental Disorders 5th edition (DSM-5), confirmed by the result of the MINI interview at screening:
a. Major Depressive Disorder (MDD)
b. Any psychotic disorder or schizoaffective disorder (e.g., Schizophrenia, Affective Psychosis)
c. Bipolar Disorder (BD)
d. Any Eating Disorder, such as Anorexia or Bulimia Nervosa
e. Any anxiety disorder (GAD, SAD, etc.)
f. OCD
g. PTSD
h. Substance use disorder
16. Currently, or have ever, had one or more of the following diagnoses according to participant self-report:
a. ADHD/ASD
b. Personality disorder
17. Have a first-degree relative with a schizophrenia spectrum diagnosis or a major affective diagnosis.
18. Currently, or ever, required any psychotropic medication, including benzodiazepines (with the exception of the intermittent use of medications such as zolpidem, zopiclone, and eszopiclone which can, for example, be used in treatment for transient sleep disturbances provided that they are not taken in the 2 weeks before screening).