Exploring biological measures to facilitate the discovery and development of new treatments for social and cognitive deficits in Alzheimer*s disease, schizophrenia, and major depression: replication and generalisability of the Psychiatric Ratings using Intermediate Stratified Markers (PRISM)1 study

Completed

Conditions: Alzheimer's disease and Major Depressive Disorder
psychotic disorder
dementia and depression
Schizophrenia
10037176

Registration Number: NL-OMON53842

Lead Sponsor: Gregorio Marañón Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

Inclusion criteria (MDD, SZ and AD populations)
- Provision of signed and dated informed consent form (ICF) from patient prior
to any study-specific procedures being performed.
- The patient should have a reliable study partner with whom he/she cohabits or
has regular contact with, who gives consent to participate in the study and
provide study data (limited to the Neuropsychiatric Inventory for AD patients
and the WHO Disability Asessment Schedule (WHODAS) for AD, SZ and MDD patients).
- Not socially withdrawn due to external circumstances (e.g. lack of access to
transport, rural location) or comorbid medical disorder or disability (e.g.,
hearing loss, lack of mobility, facial disfigurement).
- Patient and study partner must be able to read, write, and speak the language
in which assessments are provided.
- Unless otherwise stated central nervous system (CNS) medications to treat
cognitive impairment due to AD, symptoms of SZ or MDD, and other stable CNS
conditions requiring such medication, are permitted provided the patient has
been maintained on a stable dose regimen for at least 8 weeks before start of
the study, and they are expected to continue this treatment in a stable manner
during the current study. Similarly, psychological treatments (e.g., Cognitive
Behaviour Therapy, Interpersonal Psychotherapy, Psychodynamic Psychotherapy
etc.) are all permitted in this study regardless of frequency and duration, so
long as this treatment is expected to remain stable during the duration of the
study.
- Patient is right-handed or ambidextrous. In the case of ambiguity the
Edinburgh Handedness Inventory will be used to determine handedness.

Additional inclusion Criteria - AD participants
- Men and women aged 50 to 80 years (inclusive).
- Probable AD, meeting the National Institute on Aging (NIA) and the
Alzheimer*s Association (AA) (NIA-AA) criteria for probable AD
- Mini-Mental State Examination (MMSE) score of 20 to 26, inclusive.

Additional inclusion Criteria - SZ participants
- Patients are male or female, 18-45 years of age (inclusive) with an
established diagnosis of schizophrenia according to medical history.
- If the patient uses any antipsychotic, anticholinergic or antidepressant
medication, dosage needs to be stable for at least 8 weeks prior to the study
start.
- A DSM-IV diagnosis of SZ with at least one confirmed psychotic episode but
not longer than 15 years of disease duration (since first date of established
SZ clinical diagnosis). It is, however, preferred and actively encouraged to
include patients with a maximum disease duration of 10 years.

Additional inclusion Criteria - MDD participants
- Male or female, aged 18-55 years of age, inclusive. It is, however, preferred
and actively encouraged to include patients aged 45 years and under.
- Have a primary Diagnostic and Statistical Manual of Mental Disorders 4th
edition (DSM-IV) diagnosis of MDD without psychotic features, as confirmed by
medical history. Subjects with a diagnosis of comorbid Generalized Anxiety
Disorder (GAD), Social Anxiety Disorder (SAD), Panic Disorder, insomnia or
specific phobia may be included.
- Meet the DSM-IV criteria for a current Major Depressive Episode.

Additional inclusion Criteria - HC participants
- Men and women, aged 18-80, inclusive (of s

Exclusion Criteria

Exclusion criteria (MDD, SZ and AD populations)
Patients cannot enter the study if any of the following exclusion criteria are
fulfilled:
- Significant neurological disease affecting the CNS, other than AD, SZ, or MDD
(e.g. other dementias, serious infection of the brain, Parkinson*s disease,
epilepsy) as documented in the patient*s medical file which in the judgement of
the investigator may affect the patient's ability to complete the study
assessments.
- Any other current psychiatric diagnosis, including personality disorders,
requiring intervention other than AD, SZ, and MDD according to medical history
that in the judgement of the investigator may affect the patient's ability to
complete the study assessments.
- Current serious or unstable clinically important systemic illness (e.g.
hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic,
immunologic, hematologic, or ocular disorders) that in the judgement of the
investigator may affect the patient's ability to complete the study assessments.
- History of chronic alcohol or drug abuse or dependence within the previous 3
years.
- Participated in any investigational study to treat either AD, SZ, or MDD
symptoms or has taken an investigational drug within 90 days (or 5 times the
half-life of the investigational drug, whichever is longer). In addition, if
they have participated in two or more studies with an experimental drug within
5 months prior to screening.
- In the investigator*s judgement is medically non-compliant in the management
of their disease.
- Has within 6 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.
- Has any contraindications for MRI studies, including claustrophobia, the
presence of metal (ferromagnetic) implants, pregnancy, or cardiac pacemaker
that is not compatible with MRI scanning.
- Are, in the opinion of the investigator, likely to present a danger to
themselves or others or where the severity of the illness precludes them from
completing the study procedures. In the case of high suicidality scores on the
QIDS, the study researcher will contact the person who referred the participant
to the study.

Additional exclusion Criteria - AD participants
- Multiple strokes based on history and/or imaging results
- A score of 4 or greater on the global Parkinsonism item of the Extrapyramidal
Symptom Rating Scale (ESRS) (only relevant to those patients currently taking
an antipsychotic medication).
- QIDS-SR16 score of >= 16

Additional exclusion Criteria - SZ participants
Patients will be excluded from the study if they meet any of the following
criteria:
- A score of 22 or more on the sum of the 7 PANSS (The Positive and Negative
Syndrome Scale) positive symptom factor items. The score of the items of P1
(delusions), P3 (hallucinatory behaviour), P6 (suspiciousness) and G9 (unusual
thought content) meet the following requirements:
- No more than 2 of the above items have a score of 4.
- All of the above items score less than 5.
- In the clinician*s judgment, patients who, for any reason, are considered to
be a danger to themselves.
- QIDS-SR16 score of >= 16
- A score of 4 or greater