Pan European Collaboration on Antipsychotic Naïve Schizophrenia II

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2021-01-31

Brief Summary

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The study is a prospective 2 year multimodal follow-up study of initially antipsychotic-naïve first-episode psychotic patients involving a standardized intervention with monotherapy with aripiprazole during the first 6 weeks. Patients and matched healthy controls will be examined after 6 weeks, 6 months and 2 years. They will be examined with MR-scannings, neurocognitive tests, EEG, and PET-scannings.

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Detailed Description

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The study is a prospective 2 year multimodal follow-up study of initially antipsychotic-naïve first-episode psychotic patients involving a standardized intervention with monotherapy with aripiprazole during the first 6 weeks. Patients and matched healthy controls will be examined at baseline and after 6 weeks, 6 months and 2 years.

Levels of glutamate and gamma-aminobutyric acid (GABA) are measured by proton magnetic resonance spectroscopy (1H-MRS) in the anterior cingulate cortex ACC and thalamus. Presynaptic Dopamine level is measured with Positron Emission Tomography Computed Tomography (PET/CT)-scanning using 3,4-dihydroxy-6-\[18F\]fluoro-L-phenylalanine (18F-DOPA). Disturbances of the reward system is measured with functional magnetic resonance imaging (fMRI) . Regional cerebral blood flow and activity in the same regions are measured with Pseudo-continuous arterial spin labelling (pCASL). The default mode network, functional and structural connectivity in the associated macro circuits are measured with resting state fMRI, EEG, and diffusion tensor imaging. Structural brain changes (in grey and white matter) are measured with MRI. Cognitive functions are measured with a neuropsychological test battery, and early information processing with event related EEG and electromyography (EMG) (psychophysiological examinations). Further patients psychopathology will be rated.

Conditions

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Schizophrenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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antipsychotic treatment

individual doses of aripiprazole for all patients

Group Type ACTIVE_COMPARATOR

Aripiprazole

Intervention Type DRUG

6 weeks of individual doses of aripiprazole

no treatment

no treatment for all healthy controls

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Aripiprazole

6 weeks of individual doses of aripiprazole

Intervention Type DRUG

Other Intervention Names

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Abilify

Eligibility Criteria

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Inclusion Criteria

* Fulfilling the diagnostic criteria of schizophrenia or schizoaffective disorder according to ICD-10 (International Classification of Diseases version 10) or DSM-IV/V (Diagnostic and Statistical Manual version 4 /5)
* Age 18-45 years
* Never treated with antipsychotic compounds or central nervous system (CNS) stimulants
* Legally competent

* Matching patients on age (+/- 2 years), sex and parental socioeconomic status
* Age 18-45 years
* No psychiatric or physical disease

Exclusion Criteria

* Substance abuse on a daily basis during the last 3 month or patients fulfilling the criteria of ongoing substance abuse due to ICD-10/DSM-IV/V
* Treatment with antidepressant during the last 30 days
* Head injury with more than 5 minutes of unconsciousness
* Patients involuntarily admitted or treated
* Components of metal implanted by operation
* Pacemaker
* Pregnancy
* Severe physical illness

* First degree relatives with psychiatric disease
* Substance abuse during the last 3 month or positive screening of drugs in urine-sample
* Head injury with more than 5 minutes of unconsciousness
* Components of metal implanted by operation
* Pacemaker
* Pregnancy
* Severe physical illness

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Birte Glenthoj

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Birte Glenthøj, Professor

Role: STUDY_DIRECTOR

Capital Mental Health Services, Center for Neuropsykiatrisk Skizofreniforskning, CNSR & Lundbeck Foundation Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS