Clinical trial NCT02439099: Retinoic Acid Homeostasis in Neuropsychiatric Diseases
Official title: Retinoic Acid Homeostasis in Neuropsychiatric Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Major Depression
Alzheimer's Disease
Alcoholism
Schizophrenia
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2015-05-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Out- and inpatients are eligible and will be recruited from patients seeking medical treatment at the Department of Psychiatry, Campus Benjamin Franklin, Charité, University Medicine Berlin.

Brief summary: It is hypothesized, that local retinoic acid (RA) homeostasis is functionally involved in the pathophysiology of depression. In a cross-sectional (and partly longitudinal) analysis, serum RA status will be assessed in healthy controls and subjects with Major Depression, Alzheimer's disease, alcoholism and in subjects with schizophrenia.

Detailed description: Retinoids comprise of a group of small-molecule derivatives of Vitamin A with retinoic acid (RA) representing the biologically most active endogenous form. RA has multiple functions central nervous system (CNS). It is hypothesized, that local RA homeostasis is functionally involved in the pathophysiology of numerous neuropsychiatric diseases.

Eligibility criteria: MDD-Group

Inclusion Criteria:

* depressive episode in the context of unipolar major depression
* at least 18 points or more on the BDI and HAMD-17

Exclusion Criteria:

* additional or comorbid axis-I or axis-II disorder
* current history of any neurological or other serious medical condition
* any psychopharmacological treatment or substance use within the last two weeks or 5 half-lives (whichever is longer) of the respective substance
* any oral or topical application of retinoid-containing preparations within the last 3 months

AD-Group

Inclusion Criteria:

* diagnosed AD

Exclusion Criteria:

* any other neurodegenerative disorder
* any oral or topical application of retinoid-containing preparations within the last 3 months

Schizophrenia-Group

Inclusion Criteria:

* subjects with schizophrenia
* intended therapy with clozapine, olanzapine or aripiprazole
* BMI: 18 - 29,9 kg/m2

Exclusion Criteria:

* presence of diabetes or pathological glucose tolerance
* presence of and chronic inflammatory disease
* any psychopharmacological treatment of clozapine, olanzapine or aripiprazole within the last 3 months
* any oral or topical application of retinoid-containing preparations within the last 3 months

Alcoholism-Group

Inclusion Criteria:

* subjects with alcoholism who either still consume alcohol or are abstinent for at least 4 weeks

Exclusion Criteria:

* any oral or topical application of retinoid-containing preparations within the last 3 months
* current history of any neurological or other serious medical condition despite liver diseases

Primary outcomes:
measure: Serum retinoic acid (RA) levels [nM]
timeFrame: Week 0
Secondary outcomes:
measure: For MDD group: MADRS
timeFrame: Week 1, 3, 6
measure: For MDD group: BDI II
timeFrame: Week 1, 3, 6
measure: For MDD and schizophrenia Group: Change of serum retinoic acid (RA) levels [nM]
timeFrame: Week 1, 3, 6
measure: For schizophrenia group: Positive and Negative Syndrome Scale (PANSS) for Schizophrenia
timeFrame: Week 1, 3, 6
measure: For schizophrenia group: Change of metabolic parametres For schizophrenia group:Positive and Negative Syndrome Scale (PANSS)
timeFrame: Week 1, 3, 6
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Psychiatry, Charité - Campus Benjamin Franklin
Study officials:
affiliation: Chair: Department of Psychiatry, Charité, CBF
name: Isabella Heuser, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: