Clinical trial NCT00916201: Evaluation Study of New Compounds With Potential Use in Schizophrenia
Official title: Evaluation of Potential Central Glucoregulatory Compounds to Treat/Ameliorate the Symptoms of Schizophrenia: a Proof-of-concept Study in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Schizophrenia
Keywords: schizophrenia
Lead sponsor: Central Institute of Mental Health, Mannheim
Sponsor class: OTHER
Collaborators: name: Max Planck Institute for Metabolism Research
First posted: 2009-06-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Clinical assessment with several psychopathological scores for self-assessment and peer evaluation (BPRS, PANSS, SIPS, CGI, MADRS, HAM-A, SCL-90-R)
timeFrame: Seven days
measure: Laboratory assessment (routine testing, "-omics", genetic analyses, endocannabinoid levels)
timeFrame: Seven days
measure: Diagnostics of the cerebrospinal fluid
timeFrame: Seven days
measure: fMRI scan of the brain
timeFrame: Seven days
Secondary outcomes:
measure: Regular evaluating of the subject's condition and ability to continue the study by CGI
timeFrame: Seven days
measure: Regular laboratory testing and ECG
timeFrame: Seven days
measure: Scales for the assessment of adverse events (UKU, SCL- 90-R)
timeFrame: Seven days
measure: (Numbers of) SAE and AE
timeFrame: Seven days
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health
state: BW
Study officials:
affiliation: Central Institute of Mental Health
name: F. Markus Leweke, MD
role: PRINCIPAL_INVESTIGATOR
References: