Measuring cognitive deficit using cognitive tasks
Overview
We are looking for people aged between 18 and 55 yrs to take part in our study to look at the differences and similarities in cognitive processes in different patient populations.
We are looking for people experiencing Psychosis (including Schizophrenia) or Major Depressive Disorder AND healthy adults with no personal or family history of mental health problems.
There are two parts to the study. The first part of the study will be completed at home. We will invite people to take part in a telephone interview and answer several questions and then complete online assessments over a couple of days. You will receive a £80 voucher to compensate you for your time for if you complete this part of the study.
The second part of the study involves two visits to the clinic and in addition, the completion of some assessments at home over the two weeks following the visit. We will invite some of the people who complete part one to take part in part two. You will receive a further £280 (bank transfer) if you complete part two of the study, including the 2-week at-home assessment period. We will pay for a taxi to pick you up and take you home on the clinic visit days
Are you interested in taking part in this study?
Planned end date
31 Mar 2025 23:59Conditions
Depression,Psychosis,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 able to read, write, and speak the language in which psychometric tests, informed consent form (ICF) and participant information sheet (PIS) are provided, with acceptable auditory acuity (corrected if necessary).
4. Have normal or corrected to normal vision.
In addition to the four criteria above, Major Depressive Disorder (MDD) participants must fulfill the following:
5. Have a primary Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) diagnosis of MDD, confirmed by review of medical records or by review of GLAD (CIDI) questionnaire data at enrolment into part one of the study and confirmed by the result of the Mini-International Neuropsychiatric Interview (MINI) interview conducted by the site at enrolment into part 2. Subjects with a diagnosis of comorbid Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), Panic Disorder or specific phobia may be included.
6. Meet the DSM-5 criteria for a current Major Depressive Episode, with the current depressive episode not having lasted longer than 2 years.
7. If undergoing treatment, be currently treated with a single antidepressant at a stable dose for the previous 4 weeks that is 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 four criteria, Schizophrenia (SZ) participants must fulfill the following:
8. Have a primary diagnosis of schizophrenia according to the Statistical Manual of Mental Disorders 5th edition (DSM-5), confirmed by review of medical records at enrolment into part one of the study and confirmed by the result of the MINI interview conducted by the site at enrolment into part 2. Subjects with a diagnosis of comorbid Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), Panic Disorder or specific phobia may be included.
9. Have a duration of illness not exceeding 5 years from their first diagnosis of schizophrenia as assessed by their clinical records and be clinically stable and in the residual (nonacute) phase of their illness for at least 3 months
10. Unless otherwise stated, CNS medications to treat symptoms of SZ and other stable CNS conditions requiring medication is permitted, provided the daily dose of medication has not been changed in the last 4 weeks before the start of the study, and is not expected to change while participating in the study. Current treatment with a single antipsychotic (except for clozapine) must 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 have commenced in the 4 weeks before the start of the study.
Exclusion Criteria
All participants must not:
1. Have a history of substance use disorder according to DSM-5 criteria, except nicotine or caffeine, within 6 months before screening.
2. Have a diagnosis of any clinically significant neurological disease or mental disorder according to judgment of the investigator (e.g. multiple sclerosis, epilepsy, dementia and autism).
3. Have a history of severe learning disability accordingly to the judgment of the investigator.
4. Have a sleep disorder diagnosis other than insomnia (e.g. sleep apnoea, restless leg syndrome, parasomnias).
5. Have worked night shifts and/or have had transmeridian travel during the 2 weeks prior to participation.
6. 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.
7. 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 assessments.
8. Experienced an exacerbation of illness requiring hospitalization within the last 3 months
9. Have used cannabis in the 72 hours before cognitive testing.
10. Are, in the opinion of the investigator, likely to present a danger to themselves or others.
11. Are, in the opinion of the investigator, unlikely to comply with the protocol or are unsuitable for any reason.
12. 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.
13. Have regularly used any of the restricted or prohibited medication or treatment list in the table in section 8.5 Concomitant medication and treatments.
In addition to the 13 criteria above, MDD participants must not:
14. 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)
f. Subjects with comorbid GAD, SAD, panic disorder or specific phobias are not excluded.
15. Be currently treated with an antipsychotic
In addition to the first 13 criteria, SZ participants must not:
14. 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
f. Subjects with comorbid GAD, SAD, panic disorder or specific phobias are not excluded
15. Have received treatment with clozapine in the 6 months before the study
In addition to the first 13 criteria, healthy control participants must not:
14. Currently, or have ever, had one or more of the following diagnoses according to the Statistical Manual of Mental Disorders 5th edition (DSM-5), according to participant self-report at enrolment into part one of the study and confirmed by the result of the MINI interview conducted by the site at enrolment into part 2.
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
g. Substance use disorder
15. Currently, or have ever, had one or more of the following diagnoses according to participant self-report:
a. ADHD/ASD
b. Personality disorder
16. Score > 5 on the Quick Inventory of Depressive Symptomatology (QIDS) (indicative of mild depression).
17. 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 and throughout the study).
18. Have within 4 weeks prior to the first assessment visit been prescribed a medication that may affect the CNS that in the judgment of the investigator may interfere with the patient's ability to complete the study assessments.