Retinoic Acid Homeostasis in Neuropsychiatric Diseases

Charite University, Berlin, Germany200 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Major Depression Alzheimer's Disease Alcoholism Schizophrenia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Department of Psychiatry, Charité - Campus Benjamin Franklin

Berlin, Germany

RECRUITING

Outcomes

Primary Outcomes

Serum retinoic acid (RA) levels [nM]

Serum retinoic acid levels \[nM\] as determined by HPLC according to previously published protocols

Time frame: Week 0

Secondary Outcomes

For MDD group: MADRS

Questionnaire to assess symptom severity in MDD

Time frame: Week 1, 3, 6

For MDD group: BDI II

Self-rating to assess of symptom severity in MDD

Time frame: Week 1, 3, 6

For MDD and schizophrenia Group: Change of serum retinoic acid (RA) levels [nM]

Serum retinoic acid levels \[nM\] as determined by HPLC according to previously published protocols

Time frame: Week 1, 3, 6

For schizophrenia group: Positive and Negative Syndrome Scale (PANSS) for Schizophrenia

Measurement of symptom severity of patients with schizophrenia

Time frame: Week 1, 3, 6

For schizophrenia group: Change of metabolic parametres For schizophrenia group:Positive and Negative Syndrome Scale (PANSS)

Assessmant of weight, blood pressure, levels of Glucose, HbA1c, cholesterols and dietry

Time frame: Week 1, 3, 6

Central Contacts

Julian Hellmann-Regen, MD

CONTACT

Julian.Hellmann@charite.de

Vera Clemens, MD

CONTACT

Vera.Clemens@charite.com

Data from ClinicalTrials.gov

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