SchizophreniaPhase 1EICASNCT00916201
Evaluation Study of New Compounds With Potential Use in Schizophrenia
A Phase 1 study testing URB597, intranasal Insulin and Cannabidiol CR in people with Schizophrenia, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
Trial summary
Different compounds that might modify the glucose regulation in the central nervous system will be evaluated in healthy volunteers. Several examinations will be performed in order to get a detailed plan how these substances might work. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- URB597, intranasal Insulin and Cannabidiol CR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- 31 Jan 2025to 31 Jan 2025
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Informed consent given by the subject
- Both, female and male subjects may participate
- Age between 18 and 65 years
- Negative drug-screening at the time of screening
- In female participants in fertile age, reliable contraception, which means contraception's pearl-index is equal or smaller than 1.
- Non-Smoker
- Body Mass Index between 18 and 40.
Who cannot join
- Lack of accountability
- Any current psychiatric disorder through the Structured Clinical Interview for DSM-IV (SCID) at the time of screening
- Any known psychiatric or neurological illness in the participant's history.
- Known family history concerning psychiatric disorders
- Relevant use of cannabis (which is defined on the present state of knowledge as at the most five times lifetime-consumption and no consumption for at least one year)
- Pregnancy or lactation phase in female at the time of screening
- Severe physical (internal) or neurological illness, especially cardiovascular, renal, advanced respiratory, haematological or endocrinological failures or infectious diseases (acute hepatitis A, B or C or HIV) assessed at the time of the screening by the subject's history, clinical examination and laboratory testing, at the discretion of the investigator
- Consumption of any illegal drugs (except cannabis in history, see above)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health
Mannheim, Baden-Wurttemberg, 68159
About this study
Official title: Evaluation of Potential Central Glucoregulatory Compounds to Treat/Ameliorate the Symptoms of Schizophrenia: a Proof-of-concept Study in Healthy Volunteers.
Different compounds that might modify the glucose regulation in the central nervous system will be evaluated in healthy volunteers. Several examinations will be performed in order to get a detailed plan how these substances might work.
- Conditions
- Schizophrenia
- Being tested
- URB597, intranasal Insulin, Cannabidiol CR
- Keywords
- schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
URB597Drug
10 mg / d for 5 days, orally
intranasal InsulinDrug
160 IU / d for 5 days, intranasal
Cannabidiol CRDrug
Also called Arvisol
320 mg / d for 5 days, orally
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Insulin | Experimental | Intranasal administered insulin Receives: Drug: intranasal Insulin |
| Cannabidiol CR | Experimental | Cannabidiol is the main non psychoactive compound of the Cannabis sativa plant. Receives: Drug: Cannabidiol CR |
| URB597 | Experimental | URB597 is a selective inhibitor of the Fatty acid amide hydrolase enzyme. Receives: Drug: URB597 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical assessment with several psychopathological scores for self-assessment and peer evaluation (BPRS, PANSS, SIPS, CGI, MADRS, HAM-A, SCL-90-R)
Measured: Seven days
Laboratory assessment (routine testing, "-omics", genetic analyses, endocannabinoid levels)
Measured: Seven days
Diagnostics of the cerebrospinal fluid
Measured: Seven days
fMRI scan of the brain
Measured: Seven days
Secondary outcomes (4)
Regular evaluating of the subject's condition and ability to continue the study by CGI
Measured: Seven days
Regular laboratory testing and ECG
Measured: Seven days
Scales for the assessment of adverse events (UKU, SCL- 90-R)
Measured: Seven days
(Numbers of) SAE and AE
Measured: Seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2009 (estimated)
- Study start31 Jan 2025
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Why it stopped: Lack of funding
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Collaborators
- Max Planck Institute for Metabolism Research
- Responsible party
- Principal investigator, F Markus Leweke, Central Institute of Mental Health, Mannheim
- Investigators
- F. Markus Leweke, MD, Principal investigator, Central Institute of Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916201
- Sponsor's protocol ID
- EICAS
- Acronym
- EICAS
- Status last verified
- Mar 2025
- First submitted
- 5 May 2009
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Potential Central Glucoregulatory Compounds to Treat/Ameliorate the Symptoms of Schizophrenia: a Proof-of-concept Study in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT00916201
- Acronym / sponsor ID
- EICAS / EICAS
- Conditions
- Schizophrenia
- Keywords
- schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Collaborators
- Max Planck Institute for Metabolism Research
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 9 Jun 2009 (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.
Different compounds that might modify the glucose regulation in the central nervous system will be evaluated in healthy volunteers. Several examinations will be performed in order to get a detailed plan how these substances might work.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intranasal Insulin | Experimental | Drug: intranasal InsulinIntranasal administered insulin |
| Cannabidiol CR | Experimental | Drug: Cannabidiol CRCannabidiol is the main non psychoactive compound of the Cannabis sativa plant. |
| URB597 | Experimental | Drug: URB597URB597 is a selective inhibitor of the Fatty acid amide hydrolase enzyme. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy volunteers
- Informed consent given by the subject
- Both, female and male subjects may participate
- Age between 18 and 65 years
- Negative drug-screening at the time of screening
Key exclusion criteria (8 listed)
- Lack of accountability
- Any current psychiatric disorder through the Structured Clinical Interview for DSM-IV (SCID) at the time of screening
- Any known psychiatric or neurological illness in the participant's history.
- Known family history concerning psychiatric disorders
- Relevant use of cannabis (which is defined on the present state of knowledge as at the most five times lifetime-consumption and no consumption for at least one year)
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 |
|---|---|---|
| URB59710 mg / d for 5 days, orally | Drug | URB597 |
| intranasal Insulin160 IU / d for 5 days, intranasal | Drug | Intranasal Insulin |
| Cannabidiol CRAlso: Arvisol320 mg / d for 5 days, orally | Drug | Cannabidiol CR |
Primary outcome
Clinical assessment with several psychopathological scores for self-assessment and peer evaluation (BPRS, PANSS, SIPS, CGI, MADRS, HAM-A, SCL-90-R)
Time frame: Seven days
Laboratory assessment (routine testing, "-omics", genetic analyses, endocannabinoid levels)
Time frame: Seven days
Diagnostics of the cerebrospinal fluid
Time frame: Seven days
fMRI scan of the brain
Time frame: Seven days
4 secondary outcomes
Regular evaluating of the subject's condition and ability to continue the study by CGI
Time frame: Seven days
Regular laboratory testing and ECG
Time frame: Seven days
Scales for the assessment of adverse events (UKU, SCL- 90-R)
Time frame: Seven days
(Numbers of) SAE and AE
Time frame: Seven days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Schizophrenia
Recruiting
MI-CBTech: A Mobile Intervention for Community Integration in Homeless-Experienced Veterans With SMI
Schizophrenia Spectrum Disorders, Psychotic Affective Disorders
RecruitingObservational study
Tau Biomarkers in Late-onset Psychosis (LOP)
Late Onset Schizophrenia, Delusional Disorder (Late Onset)
Active, not recruitingObservational study
Profiling Vulnerability and Resilience for Mental Illness Following Viral Infections
Severe Mental Illness, Inflammation
RecruitingPhase 3
Sequential Treatment Approaches for Treatment-Resistant Schizophrenia
Treatment-resistant Schizophrenia
Recruiting
REACH Study (Recovery Environments: Assessing Cognitive & Brain Health in Community Mental Health)
Schizophrenia, Schizo Affective Disorder
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.
F. Markus Leweke, MD principal investigator
Central Institute of Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing URB597, intranasal Insulin and Cannabidiol CR in people with Schizophrenia, run by Central Institute of Mental Health, Mannheim at 1 site 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 8 inclusion and 8 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: withdrawn, as of the sponsor's last update on 21 Mar 2025. 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 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Clinical assessment with several psychopathological scores for self-assessment and peer evaluation (BPRS, PANSS, SIPS, CGI, MADRS, HAM-A, SCL-90-R) (time frame: Seven days). The study lists 4 primary outcomes in all. 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 21 Mar 2025.