Prodromal schizophrenia Mental and Behavioural Disorders Schizotypal disorder
Conditions
Interventions
Experimental intervention I - Clinical Management and Aripiprazole combined (CM + ARI):
ARI will be provided by the treating physician in a blister of 28 tablets and are supposed to be
weekly in the first 4 weeks, biweekly in the next 20 weeks and every fourth week over the following 28 weeks. The initial session will be 45 to 60 minutes, with other sessions 20 to 30 minutes long. T
weekly for the first 16 weeks, biweekly over the next 20 weeks and every fourth week over the next 16 weeks. The sessions will be 50 minutes long. The CBT will be separated into assessment/engagement,
Sponsors
University of Cologne (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 19/03/2019: 1. Aged between 18 - 49 years 2. Belong to one of the following groups: 2.1. Attenuated Positive Symptoms (APS) 2.2. Brief Limited Intermittent Psychotic Symptoms (BLIPS) 2.3. Predictive basic symptoms 2.4. Family risk plus reduced functioning 3. Verbal Intelligence Quotient (IQ) greater than 70 4. Written informed consent Previous participant inclusion criteria: 1. Aged between 18 - 40 years 2. Belong to one of the following groups: 2.1. Attenuated Positive Symptoms (APS) 2.2. Brief Limited Intermittent Psychotic Symptoms (BLIPS) 2.3. Predictive basic symptoms 2.4. Family risk plus reduced functioning 3. Verbal Intelligence Quotient (IQ) greater than 70 4. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Present or past diagnosis of a schizophrenic, schizophreniform, schizoaffective, delusional or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV) 2. Present or past diagnosis of a brief psychotic disorder according to DSM IV with a duration equal to or of more than one week or within the last 4 weeks regardless of its duration 3. Diagnosis of delirium, dementia, amnestic or other cognitive disorder, mental retardation, autism spectrum disorders, psychiatric disorders due to a somatic factor or related to psychotropic substances according to DSM IV 4. Alcohol or drug dependence according to DSM IV 5. Diseases of the central nervous system (inflammatory, traumatic, epilepsy etc.) 6. Magnetic Resonance Imaging (MRI) or Electroencephalogram (EEG) abnormalities 7. Current or past antipsychotic treatment for longer than 1 week 8. Current or past antipsychotic treatment shorter than 1 week without a washout phase of at least 4 weeks 9. Current pregnancy, lactation or missing reliable method of contraception 10. Current suicidality or dangerous behaviour 11. Contraindication according to Summary of Product Characteristics (SmPC): known intolerance of the active pharmaceutical ingredient or another ingredient of verum or placebo 12. Use of drugs with anticipated interactions (in accordance to SmPC) 13. Participance in other clinical trials, which could intervene with the present trial 14. Persons who are depending on the investigator or the sponsor 15. Hospitalisation due to legal or regulatory devices
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 19/03/2019: The primary endpoint is given by the dichotomous outcome measure “progression to psychosis”, which is summarized through estimation of a time-dependent cumulative event rate. Progression to psychosis is defined by the transition to psychosis or progression from an early to a late initial prodromal state given the following order: 1. genetic Risk and/or schizotypal disorder and functional decline (GRFD) 2. Cognitive disturbances (COGDIS) 3. Attenuated positive symptoms (APS) 4. Brief limited intermittent psychotic symptoms (BLIPS) Previous primary outcome measure: The primary endpoint is given by the dichotomous outcome measure "transition to psychosis", which is summarised through an event rate within a time interval. The event "transition to psychosis" will be operationalised by one or more of 5 Scale Of Prodromal Symptomatology (SOPS) positive items rated with score = 6 longer than 7 days, to be further specified as DSM IV codes 292.11-12, 295.1-4, 295.7, 295.9, 296.04, 296.24, 296.34, 297.1, 298.8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 19/03/2019: 1. Dichotomous outcome measure "transition to psychosis", which is summarised through an event rate within a time interval. The event "transition to psychosis" will be operationalised by one or more of 5 Scale Of Prodromal Symptomatology (SOPS) positive items rated with score = 6 longer than 7 days, to be further specified as DSM IV codes 292.11-12, 295.1-4, 295.7, 295.9, 296.04, 296.24, 296.34, 297.1, 298.8. 2. Psychopathological symptoms: 2.1. Prodromal symptoms (Ultra High Risk [UHR]): Severity of prodromal symptoms as described by the UHR criteria will be interview-measured by the SOPS. The SOPS is a 19-item scale designed to measure changes in symptomatology over time. It contains positive, negative, disorganisation and general symptoms sub-scores 2.2. Basic Symptoms (BS): The severity of BS will be assessed by a short version and the complete interviewer-administered Schizophrenia Prediction Instrument, Adult version (SPI-A). The SPI-A is a 34-items scale with 6 subscales designed to quantify basic symptoms and to complement SOPS 2.3. Schizophrenia symptoms will be interviewer-measured by the Positive and Negative Syndrome Scale (PANSS), which gives a total score as well as positive, negative and general psychopathology sub-scores 2.4. Depression: Symptoms of depression will be self-rated by the Beck Depression Inventory (BDI) and interviewer rated by the Montgomery Asperg Depression Rating Scale (MADRS), which contain one total score each 2.5. Anxiety: Anxiety will be self-rated by the State Trait Anxiety Inventory (STAI) which gives a state and a trait anxiety scale 2.6. Psychiatric diagnosis: Structured clinical interview for DSM-IV, Structured Clinical Interview for DSM-IV (SCID) I and II, for the structured investigation of actual and past mental illnesses according to DSM IV | — |
Countries
Germany
Outcome results
None listed