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Language and Functional Capacity in patients with Depression and Psychosis (CALM Study)

Overview

We are looking for people aged between 18 and 60 yrs experiencing Psychosis (including Schizophrenia) or Major Depressive Disorder AND healthy adults with no history of mental health problems to take part in our study looking at the differences and similarities in cognitive processes, and the relationship between speech and severity of symptoms and level of functioning in different patient populations.

There are three parts to the study. The 1st part of the study will be completed at home. You will take part in a telephone interview to make sure you are eligible and then, if you are, you will complete some assessments at home using a tablet device (provided by us) and take part in a role play activity during a video call with one of the research team on two days. You will receive a £80 voucher to compensate you for your time.

The second and third parts of the study are optional. You can decide if you want to take part once you have completed part one. The second part of the study involves two visits to the clinic at Kings College, Denmark Hill, London, to complete some more assessments in person.

The third part of the study involves completing assessments at home, every two weeks over eight months (total of 16 occasions).

You will receive £540 if you complete parts two and three of the study, or £320 if you just complete part three.

Are you interested in taking part in this study?
Find out more by filling in this form

Planned end date

30 Nov 2024 19:28

Conditions

Depression,Psychosis

Inclusion 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 60 years inclusive at the beginning of the study
  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, MDD participants must fulfil the following:

  • 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 conducted at screening. Subjects with a diagnosis of comorbid Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), Panic Disorder or specific phobia may be included
  • Have a primary Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) diagnosis of MDD> 1 year prior to screening
  • If undergoing treatment, be currently treated with a single antidepressant at a stable dose for the 4 weeks prior to screening that is not exceeding licensing guidelines. Psychological treatments (e.g., Cognitive Behaviour Therapy, Interpersonal Psychotherapy, Psychodynamic Psychotherapy etc.) are all permitted in this study as long as they have not been commenced in the 6 weeks before the start of the study

In addition to the first four criteria, SZ participants must fulfil the following:

  • Have a primary diagnosis of schizophrenia according to the Statistical Manual of Mental Disorders 5th edition (DSM-5), confirmed by the result of the MINI interview conducted at screening.  Subjects diagnosed with unspecified schizophrenia spectrum and other psychotic disorder may be included if, according to the judgment 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
  • Have a duration of illness not exceeding 10 years from their first diagnosis of psychosis and be clinically stable (in the investigators’ opinion) and in the nonacute phase of their illness
  • 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 is not expected to change during parts one and two of the study. Current treatment with antipsychotic medication 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 be commenced or change modality during parts one and two 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 speech impairment, hearing impairment or other neurological impairment that may interfere with the ability to complete speech and cognitive assessments, according to the PI’s judgement
  3. 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)
  4. Have a history of severe learning disability accordingly to the judgment of the investigator
  5. Have a sleep disorder diagnosis other than insomnia (e.g. sleep apnoea, restless leg syndrome, parasomnias)
  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 12 criteria above, MDD participants must not have a diagnosis of and of the following:

  • Bipolar Disorder (BD)
  • Any Eating Disorder, such as Anorexia or Bulimia Nervosa
  • Obsessive Compulsive Disorder (OCD)
  • Post-traumatic Stress Disorder (PTSD)
  • ADHD/ Autism spectrum disorder (ASD)
  • Subjects with comorbid GAD, SAD, panic disorder or specific phobias are not excluded.
  • Be currently treated with an antipsychotic

In addition to the first 12 criteria, SZ participants must not also have a diagnosis of:  

  • Bipolar Disorder (BD)
  • Any Eating Disorder, such as Anorexia or Bulimia Nervosa
  • Obsessive Compulsive Disorder (OCD)
  • Post-traumatic Stress Disorder (PTSD)
  • ADHD/ASD
  • Subjects with comorbid GAD, SAD, panic disorder or specific phobias are not excluded

In addition to the first 12 criteria, healthy control participants must not 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.

  • Major Depressive Disorder (MDD)
  • Any psychotic disorder or schizoaffective disorder (e.g. Schizophrenia, Affective Psychosis)
  • Bipolar Disorder (BD)
  • Any Eating Disorder, such as Anorexia or Bulimia Nervosa
  • Any anxiety disorder (GAD, SAD, etc.)
  • OCD
  • PTSD
  • Substance use disorder

Currently, or have ever, had one or more of the following diagnoses according to participant self-report:

  • a. ADHD/ASD
  • b. Personality disorder

Currently requiring 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).

Have within four 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.

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