SchizophreniaNCT01555814
Optimization of Treatment and Management of Schizophrenia in Europe (OPTIMISE): Substudy Site Copenhagen
A study testing Amisulpride in people with Schizophrenia and Schizophreniform Disorder, run by Birte Glenthoj at 1 site in Denmark.
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 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder
- What is being tested?
- Amisulpride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteDenmark
- Study dates
- May 2011to Oct 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Schizophrenia, schizophreniform or schizoaffective disorder (DSM-IV)
- Age 18-40 years
- Written informed consent.
Who cannot join
- A time interval between the onset of positive symptoms (hallucinations and/or delusions) and study entry exceeding two years.
- Prior use of antipsychotic medication longer than an episode of two weeks in the previous year and/or 6 weeks lifetime.
- Intolerance to one of the drugs in this study. Patients who are coercively treated at a psychiatric ward (based on a judicial ruling)
- Patients who are represented by a legal ward or under legal custody
- The presence of one or more of the contraindications against any of the study drugs as mentioned in the SPC texts
- Pregnancy, as determined through a pregnancy test, or lactation
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup Glostrup, Denmark
Glostrup Municipality
About this study
Official title: Optimization of Treatment and Management of Schizophrenia in Europe (OPTIMISE): 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. The investigators do not expect any effect of treatment on brain structure.
Read the detailed description
The study is designed as a 4 week case-control follow-up study of 90 FE pt. with SCZ and 90 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 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 4 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 4 weeks. 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.
- Being tested
- Amisulpride
- Keywords
- dopamine, first episode, reward, cognition, MRI, fMRI, PPI, P300, P50 gating, endophenotypes
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmisulprideDrug
Also called Solian
4-week open label amisulpride treatment
| Study group | Role | What they receive |
|---|---|---|
| Amisulpride | Experimental | For 4 weeks, all patients will be treated with amisulpride open label. Receives: Drug: Amisulpride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between specific neuropsychiatric measures and global improvement on PANSS scores
Changes in neuropsychiatric measures like (e.g. PPI, P50-suppression, neurocogtion etc.) will be evaluated and related to the primary outcome measure of the main OPTiMiSE study, the PANSS score change from baseline to follow-up.
Measured: 4 weeks of medical treatment
Secondary outcomes (6)
Effect of antipsychotic medication on the D2 binding potential (SPECT) in antipsychotic naive patients with schizophrenia.
D2 receptor binding will be evaluated at baseline and after 4 weeks of treatment. This will be related to measures of the human reward system.
Measured: Baseline, 4 weeks
Effect of antipsychotic medication on P50-suppression
Time/dose improvement on P50 suppression after antipsychotic treatment
Measured: Baseline, 4 weeks, 6,12,24 months
Effect of antipsychotic medication on the human reward system
Disturbances in the human reward system in antipsychotic naive patients with schizophrenia will be evaulated using a reward related BOLD fMRI paradigme.
Measured: Baseline and 4 weeks follow up
Change in hippocampal and basal ganglia volume from baseline to follow-up.
Hippocampal volume decrease and basal ganglia volume increase is expected longitudinal outcomes.
Measured: 4 weeks, 6, 12 and 24 months,
Change in processing speed over time after antipsychotic treatment.
Processing speed is expected to improve.
Measured: Baseline, 4 weeks, 6,12,24 months
Change in levels of brain perfusion from baseline to follow-up.
Brain perfusion levels will be measured in brain areas related to the human reward systems.
Measured: Baseline, 4 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startMay 2011
- Primary completionJul 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Birte Glenthoj
- Sponsor type
- University, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen, Copenhagen University Hospital, Rigshospitalet, Institute of Psychiatry, London, UMC Utrecht, Copenhagen Hospital Corporation
- Responsible party
- Sponsor-investigator, Birte Glenthoj, University of Copenhagen
- Investigators
- Birte Glenthøj, MD, DMSc, Principal investigator, Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup Glostrup, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555814
- Sponsor's protocol ID
- H-1-2010-142
- Status last verified
- Oct 2016
- First submitted
- 19 Sep 2011
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Treatment and Management of Schizophrenia in Europe (OPTIMISE): the Effects of D2 Antagonism on Candidate Endophenotypes
- ClinicalTrials.gov ID
- NCT01555814
- Acronym / sponsor ID
- H-1-2010-142
- Keywords
- dopamine, first episode, reward, cognition, MRI, fMRI, PPI, P300
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Birte GlenthojUniversity, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen, Copenhagen University Hospital, Rigshospitalet, Institute of Psychiatry, London, UMC Utrecht, Copenhagen Hospital Corporation
- Study start
- May 2011
- Primary completion
- Jul 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 15 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. The investigators do not expect any effect of treatment on brain structure.
Detailed description
The study is designed as a 4 week case-control follow-up study of 90 FE pt. with SCZ and 90 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 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 4 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 4 weeks. 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amisulpride | Experimental | Drug: AmisulprideFor 4 weeks, all patients will be treated with amisulpride open label. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Schizophrenia, schizophreniform or schizoaffective disorder (DSM-IV)
- Age 18-40 years
- Written informed consent.
Key exclusion criteria (6 listed)
- A time interval between the onset of positive symptoms (hallucinations and/or delusions) and study entry exceeding two years.
- Prior use of antipsychotic medication longer than an episode of two weeks in the previous year and/or 6 weeks lifetime.
- Intolerance to one of the drugs in this study. Patients who are coercively treated at a psychiatric ward (based on a judicial ruling)
- Patients who are represented by a legal ward or under legal custody
- The presence of one or more of the contraindications against any of the study drugs as mentioned in the SPC texts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmisulprideAlso: Solian4-week open label amisulpride treatment | Drug | Amisulpride |
Primary outcome
Relationship between specific neuropsychiatric measures and global improvement on PANSS scores
Time frame: 4 weeks of medical treatment
Changes in neuropsychiatric measures like (e.g. PPI, P50-suppression, neurocogtion etc.) will be evaluated and related to the primary outcome measure of the main OPTiMiSE study, the PANSS score change from baseline to follow-up.
6 secondary outcomes
Effect of antipsychotic medication on the D2 binding potential (SPECT) in antipsychotic naive patients with schizophrenia.
Time frame: Baseline, 4 weeks
Effect of antipsychotic medication on P50-suppression
Time frame: Baseline, 4 weeks, 6,12,24 months
Effect of antipsychotic medication on the human reward system
Time frame: Baseline and 4 weeks follow up
Change in hippocampal and basal ganglia volume from baseline to follow-up.
Time frame: 4 weeks, 6, 12 and 24 months,
Change in processing speed over time after antipsychotic treatment.
Time frame: Baseline, 4 weeks, 6,12,24 months
Change in levels of brain perfusion from baseline to follow-up.
Time frame: Baseline, 4 weeks treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Site home pageLink provided by the sponsor.
- Site home pageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birte Glenthøj, MD, DMSc principal investigator
Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup Glostrup, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amisulpride in people with Schizophrenia and Schizophreniform Disorder, run by Birte Glenthoj 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 3 inclusion and 6 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 Oct 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 global improvement on PANSS scores (time frame: 4 weeks of medical treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2016.