Measuring cognitive deficit using cognitive tasks
Overview
Volunteers required for research study at King’s College London
We are undertaking medical research to understand differences and similarities in thought processes in people with Psychosis or Major Depressive Disorder (MDD).
The study has two parts. Part one involves a screening phone call and completion of some online questionnaires and tasks at home. Part two requires you to come Denmark Hill for assessments on two days so that we can compare the online tasks to tests which are commonly used in clinical practice, followed by completion of some more online assessments at home over the next two weeks.
Transport to and from the clinic can be provided and you will also be compensated for your time.
If you have a diagnosis of Psychosis, (including Schizophrenia) or Major Depressive Disorder (MDD) and are interested in finding out more about the study, you can contact the study team directly.
Are you interested in taking part in this study?
Planned end date
30 Jun 2024 20:32Conditions
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 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 4 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 4 criteria, Schizophrenia (SZ) participants must fulfill the following:
5. 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.
6. 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
7. 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
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. Have used cannabis in the 12 hours before cognitive testing.
9. Are, in the opinion of the investigator, likely to present a danger to themselves or others.
10. Are, in the opinion of the investigator, unlikely to comply with the protocol or are unsuitable for any reason.
11. 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.
12. 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:
13. 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.
14. 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
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
h. 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. 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).
17. 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.
