SchizophreniaNCT00166322
Dopaminergic Neurotransmission in Schizophrenia, Patients at Risk and Healthy Subjects
A study testing IBZM-SPECT (bolus and constant infusion paradigm) in people with Schizophrenia, run by Ludwig-Maximilians - University of Munich at 2 sites in Germany.
Trial summary
This study is an investigation of the dopaminergic neurotransmission in patients with schizophrenia, patients at risk for the development of schizophrenia, and healthy controls using an iodobenzamide-single photon emission computed tomography (IBZM-SPECT) imaging technique under amphetamine challenge. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- IBZM-SPECT (bolus and constant infusion paradigm)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 35 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2004to Dec 2007
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of schizophrenia (currently unmedicated)
- Subjects at risk for the development of schizophrenia (prodromal symptoms)
- Healthy subjects
- Written informed consent
Who cannot join
- Neurological or severe somatic disorders
- Women during pregnancy or lactation
- Occupational exposition to radiation > 15mSv
- Medication known to interfere with IBZM
- Contraindications for the use of amphetamine challenge
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Dept. of Psychiatry
Munich, D-80336
Dept. of Nuclear Medicine
Munich, D-81377
About this study
This study is an investigation of the dopaminergic neurotransmission in patients with schizophrenia, patients at risk for the development of schizophrenia, and healthy controls using an iodobenzamide-single photon emission computed tomography (IBZM-SPECT) imaging technique under amphetamine challenge.
- Conditions
- Schizophrenia
- Being tested
- IBZM-SPECT (bolus and constant infusion paradigm)
- Keywords
- IBZM-SPECT, Amphetamine Challenge, Schizophrenia, dopaminergic neurotransmission, Persons at risk for the development of schizophrenia, healthy subjects
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBZM-SPECT (bolus and constant infusion paradigm)Procedure or surgery
single IBZM-SPECT assessment at study inclusion
What is being measured
The primary outcome is the main question the study is designed to answer.
dopamine receptor availability
Measured: cross-sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionDec 2007
- Study completionDec 2007
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Investigators
- Oliver Pogarell, MD, Principal investigator, Dept. of Psychiatry, University of MunichKlaus Tatsch, MD, Principal investigator, Dept. of Nuclear Medicine, University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00166322
- Sponsor's protocol ID
- DYN-SPECT-Pogarell
- Other IDs
- EK076/03
- Status last verified
- May 2008
- First submitted
- 9 Sep 2005
- Last updated
- 7 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dopaminergic Neurotransmission in Schizophrenia, Patients at Risk and Healthy Subjects
- ClinicalTrials.gov ID
- NCT00166322
- Acronym / sponsor ID
- DYN-SPECT-Pogarell
- Conditions
- Schizophrenia
- Keywords
- IBZM-SPECT, Amphetamine Challenge, Schizophrenia, dopaminergic neurotransmission, Persons at risk for the development of schizophrenia, healthy subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 14 Sep 2005 (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.
This study is an investigation of the dopaminergic neurotransmission in patients with schizophrenia, patients at risk for the development of schizophrenia, and healthy controls using an iodobenzamide-single photon emission computed tomography (IBZM-SPECT) imaging technique under amphetamine challenge.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of schizophrenia (currently unmedicated)
- Subjects at risk for the development of schizophrenia (prodromal symptoms)
- Healthy subjects
- Written informed consent
Key exclusion criteria (5 listed)
- Neurological or severe somatic disorders
- Women during pregnancy or lactation
- Occupational exposition to radiation > 15mSv
- Medication known to interfere with IBZM
- Contraindications for the use of amphetamine challenge
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 |
|---|---|---|
| IBZM-SPECT (bolus and constant infusion paradigm)single IBZM-SPECT assessment at study inclusion | Procedure or surgery | – |
Primary outcome
dopamine receptor availability
Time frame: cross-sectional
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 7 May 2008.
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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.
Oliver Pogarell, MD principal investigator
Dept. of Psychiatry, University of Munich
Klaus Tatsch, MD principal investigator
Dept. of Nuclear Medicine, University of Munich
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IBZM-SPECT (bolus and constant infusion paradigm) in people with Schizophrenia, run by Ludwig-Maximilians - University of Munich at 2 sites in Germany.
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 4 inclusion and 5 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 7 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
dopamine receptor availability (time frame: cross-sectional). 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 7 May 2008.