Pan European Collaboration on Antipsychotic Naive Schizophrenia (PECANS)

Sponsor

University of Copenhagen (Other)

Overall Status

Completed

CT.gov ID

NCT01154829

Collaborator

Glostrup University Hospital, Copenhagen (Other), Rigshospitalet, Denmark (Other), Institute of Psychiatry, London (Other), UMC Utrecht (Other), Copenhagen Hospital Corporation (Other)

136

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators want to relate disturbances in first-episode schizophrenic patients in (dopaminergic) D2 receptors, brain structure, brain function, and information processing to each other and to psychopathology. Additionally, the investigators want to examine the influence of D2 receptor blockade on these disturbances. The investigators expect disturbances in the dopaminergic system at baseline to correlate with specific structural and functional changes and with disruption in information processing as measured with psychophysiological and neurocognitive methods - and investigators expect D2 receptor blockade to reverse some of the functional and cognitive impairments.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: amisulpride Drug: aripiprazole	N/A

Detailed Description

The study is designed as a 6 week case-control follow-up study of 70 AN FE pt. with SCZ and 70 controls matched with regard to age, gender, and parental socio-economic status. All subjects will be examined with a diagnostic interview (SCAN, Schedule for Clinical Assessment in Neuropsychiatry), medical and family history, and physical examination before inclusion. At baseline all subjects will be examined with single photon emission computed tomography (SPECT), MRI, fMRI, psychophysiology, neurocognition. In addition, they will be screened for drugs, genetic testing, and ECG. Patients will further be examined with clinical validated rating scales to measure psychopathology, subjective well-being, and side-effects. After a period of 6 weeks all assessments are repeated. During that period patients will be treated with amisulpride, while healthy controls will receive no treatment at all. Efficacy of antipsychotic treatment will be evaluated after this initial period of 6 weeks. Based on this evaluation it will be decided to either continue the current (amisulpride) antipsychotic treatment, or to switch to aripiprazole. Efficacy of aripiprazole is evaluated on a monthly basis, if the patient does not respond well enough, than the treatment will be adapted individually. Regardless of treatment, all subjects will be re-assessed in the same test battery as mentioned above, except for SPECT and fMRI, after a period of 6, 12, and 24 months. The developement in specific disturbances and the relationship between these will be analysed.

Study Design

Study Type:

Interventional

Actual Enrollment :

136 participants

Allocation:

Non-Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Pan European Collaboration on Antipsychotic Naive Schizophrenia (PECANS): the Effects of D2 Antagonism on Candidate Endophenotypes

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: first choice treatment Treatment with amisulpride	Drug: amisulpride Individually dosed, according to symptoms, for a period of 6 weeks Other Names: Solian
Active Comparator: second choice treatment treatment with aripiprazole	Drug: aripiprazole Individually dosed, according to symptoms, for a period of 6 weeks Other Names: abilify

Arm

Intervention/Treatment

Active Comparator: first choice treatment

Treatment with amisulpride

Drug: amisulpride

Individually dosed, according to symptoms, for a period of 6 weeks

Other Names:

Solian

Active Comparator: second choice treatment

treatment with aripiprazole

Drug: aripiprazole

Individually dosed, according to symptoms, for a period of 6 weeks

Other Names:

abilify

Outcome Measures

Primary Outcome Measures

Relationship between specific neuropsychiatric measures and improvement on PANSS scores [6 weeks of medical treatment]

Secondary Outcome Measures

The relation between D2 binding potential (SPECT) and reward related brain activity (fMRI BOLD response) before and after D2 blockade [Baseline, 6 weeks]
Time/dose improvement on PPI and other psychophysiological measures of early information processing after D2 blockade [Baseline, 2 and 6 weeks, 6,12,24 months]
Disturbances in reward related fMRI BOLD response in antipsychotic naive schizophrenic patients [Baseline and 6 weeks follow up]
Structural changes in grey and white matter before and after D2 blockade [6 weeks, 6, 12 and 24 months,]
Cognitive differences at baseline and changes over time after D2 blockade [Baseline, 6 weeks, 6,12,24 months]
The effect of D2 blockade on reward related fMRI BOLD response [6 weeks of medical treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

For patients: meeting diagnostic criteria for schizophrenia according to ICD 10 or DSM IV antipsychotic naive The controls will be matched to the patients according to gender age and parental socio-economic status.