Evaluation Study of New Compounds With Potential Use in Schizophrenia (EICAS)
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ClinicalTrials.gov Identifier: NCT00916201 |
Recruitment Status :
Not yet recruiting
First Posted : June 9, 2009
Last Update Posted : August 14, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Schizophrenia | Drug: URB597 Drug: intranasal Insulin Drug: Cannabidiol CR | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 86 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Evaluation of Potential Central Glucoregulatory Compounds to Treat/Ameliorate the Symptoms of Schizophrenia: a Proof-of-concept Study in Healthy Volunteers. |
Estimated Study Start Date : | June 2020 |
Estimated Primary Completion Date : | June 2022 |
Estimated Study Completion Date : | December 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Intranasal Insulin
Intranasal administered insulin
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Drug: intranasal Insulin
160 IU / d for 5 days, intranasal |
Experimental: Cannabidiol CR
Cannabidiol is the main non psychoactive compound of the Cannabis sativa plant.
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Drug: Cannabidiol CR
320 mg / d for 5 days, orally
Other Name: Arvisol |
Experimental: URB597
URB597 is a selective inhibitor of the Fatty acid amide hydrolase enzyme.
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Drug: URB597
10 mg / d for 5 days, orally |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00916201
Contact: F. Markus Leweke, MD | +49 621 1703 ext 2321 | leweke@cimh.de | |
Contact: Cathrin Rohleder, PhD | +49 621 1703 ext 2333 | rohleder@cimh.de |
Germany | |
Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health | |
Mannheim, BW, Germany, 68159 | |
Contact: F. Markus Leweke, MD +49 621 1703 ext 2321 leweke@cimh.de | |
Contact: Cathrin Rohleder, PhD +49 621 1703 ext 2333 rohleder@cimh.de | |
Sub-Investigator: J. Malte Bumb, MD | |
Sub-Investigator: Cathrin Rohleder, PhD | |
Sub-Investigator: Till van der List, MD | |
Sub-Investigator: Juliane K. Mueller, MD | |
Sub-Investigator: Frank Enning, MD |
Principal Investigator: | F. Markus Leweke, MD | Central Institute of Mental Health |
Responsible Party: | F Markus Leweke, Professor, Central Institute of Mental Health, Mannheim |
ClinicalTrials.gov Identifier: | NCT00916201 |
Other Study ID Numbers: |
EICAS |
First Posted: | June 9, 2009 Key Record Dates |
Last Update Posted: | August 14, 2019 |
Last Verified: | August 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
schizophrenia |
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Cannabidiol Anticonvulsants |