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SchizophreniaPECANSNCT01154829

Pan European Collaboration on Antipsychotic Naive Schizophrenia (PECANS)

A study testing amisulpride and aripiprazole in people with Schizophrenia, run by University of Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Schizophrenia
What is being tested?
amisulpride and aripiprazole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
1 siteDenmark
Study dates
Dec 2008to May 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
  • -

Who cannot join

  • Patients: mental retardation, other chronic diseases, use of antidepressive medicine during the last month,being pregnant, on going substance abuse
  • Controls: psychiatric diagnosis, psychiatric diagnosis in first-degree relatives,on going drug abuse, mental retardation -

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup

    Glostrup Municipality, DK-2600

Other trials in Denmark

About this study

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

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.

Read the 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.

Conditions
Schizophrenia
Being tested
amisulpride, aripiprazole
Keywords
dopamine, first episode, reward, cognition, MRI, fMRI, PPI, P300, P50 gating, endophenotypes
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • amisulprideDrug

    Also called Solian

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

  • aripiprazoleDrug

    Also called abilify

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

Study groups in NCT01154829
Study groupRoleWhat they receive
first choice treatmentActive comparatorTreatment with amisulpride
Receives: Drug: amisulpride
second choice treatmentActive comparatortreatment with aripiprazole
Receives: Drug: aripiprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relationship between specific neuropsychiatric measures and improvement on PANSS scores

    Measured: 6 weeks of medical treatment

Secondary outcomes (6)

  1. The relation between D2 binding potential (SPECT) and reward related brain activity (fMRI BOLD response) before and after D2 blockade

    Measured: Baseline, 6 weeks

  2. Time/dose improvement on PPI and other psychophysiological measures of early information processing after D2 blockade

    Measured: Baseline, 2 and 6 weeks, 6,12,24 months

  3. Disturbances in reward related fMRI BOLD response in antipsychotic naive schizophrenic patients

    Measured: Baseline and 6 weeks follow up

  4. Structural changes in grey and white matter before and after D2 blockade

    Measured: 6 weeks, 6, 12 and 24 months,

  5. Cognitive differences at baseline and changes over time after D2 blockade

    Measured: Baseline, 6 weeks, 6,12,24 months

  6. The effect of D2 blockade on reward related fMRI BOLD response

    Measured: 6 weeks of medical treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2010 (estimated)
  2. Study startDec 2008
  3. Primary completionMay 2014
  4. Study completionMay 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01154829
Sponsor's protocol ID
H-D-2008-088
Acronym
PECANS
Status last verified
May 2016
First submitted
21 Jun 2010
Last updated
26 May 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Thomas MB, Raghava JM, Pantelis C, Rostrup E, Nielsen MO, Jensen MH, Glenthoj BY, Mandl RCW, Ebdrup BH, Fagerlund B. Associations between cognition and white matter microstructure in first-episode antipsychotic-naive patients with schizophrenia and healthy controls: A multivariate pattern analysis. Cortex. 2021 Jun;139:282-297. doi: 10.1016/j.cortex.2021.03.003. Epub 2021 Mar 18.

    PubMed 33933719

  • Wulff S, Nielsen MO, Rostrup E, Svarer C, Jensen LT, Pinborg L, Glenthoj BY. The relation between dopamine D2 receptor blockade and the brain reward system: a longitudinal study of first-episode schizophrenia patients. Psychol Med. 2020 Jan;50(2):220-228. doi: 10.1017/S0033291718004099. Epub 2019 Jan 15.

    PubMed 30642415

  • Ebdrup BH, Axelsen MC, Bak N, Fagerlund B, Oranje B, Raghava JM, Nielsen MO, Rostrup E, Hansen LK, Glenthoj BY. Accuracy of diagnostic classification algorithms using cognitive-, electrophysiological-, and neuroanatomical data in antipsychotic-naive schizophrenia patients. Psychol Med. 2019 Dec;49(16):2754-2763. doi: 10.1017/S0033291718003781. Epub 2018 Dec 18.

    PubMed 30560750

  • Jessen K, Mandl RCW, Fagerlund B, Bojesen KB, Raghava JM, Obaid HG, Jensen MB, Johansen LB, Nielsen MO, Pantelis C, Rostrup E, Glenthoj BY, Ebdrup BH. Patterns of Cortical Structures and Cognition in Antipsychotic-Naive Patients With First-Episode Schizophrenia: A Partial Least Squares Correlation Analysis. Biol Psychiatry Cogn Neurosci Neuroimaging. 2019 May;4(5):444-453. doi: 10.1016/j.bpsc.2018.09.006. Epub 2018 Sep 25.

    PubMed 30420252

  • Jessen K, Rostrup E, Mandl RCW, Nielsen MO, Bak N, Fagerlund B, Glenthoj BY, Ebdrup BH. Cortical structures and their clinical correlates in antipsychotic-naive schizophrenia patients before and after 6 weeks of dopamine D2/3 receptor antagonist treatment. Psychol Med. 2019 Apr;49(5):754-763. doi: 10.1017/S0033291718001198. Epub 2018 May 8.

    PubMed 29734953

  • Anhoj S, Odegaard Nielsen M, Jensen MH, Ford K, Fagerlund B, Williamson P, Glenthoj B, Rostrup E. Alterations of Intrinsic Connectivity Networks in Antipsychotic-Naive First-Episode Schizophrenia. Schizophr Bull. 2018 Oct 17;44(6):1332-1340. doi: 10.1093/schbul/sbx171.

    PubMed 29373756

  • Nielsen MO, Rostrup E, Wulff S, Bak N, Broberg BV, Lublin H, Kapur S, Glenthoj B. Improvement of brain reward abnormalities by antipsychotic monotherapy in schizophrenia. Arch Gen Psychiatry. 2012 Dec;69(12):1195-204. doi: 10.1001/archgenpsychiatry.2012.847.

    PubMed 22868877

Questions about this trial

What is this clinical trial studying?

A study testing amisulpride and aripiprazole in people with Schizophrenia, run by University of Copenhagen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relationship between specific neuropsychiatric measures and improvement on PANSS scores (time frame: 6 weeks of medical treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01154829, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2016.

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