Retinoic Acid Homeostasis in Neuropsychiatric Diseases

Schizophrenia Clinical Trial

— RAHND  

Official title:

Retinoic Acid Homeostasis in Neuropsychiatric Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02439099
• Other study ID #: EA4/002/13
• Status: Recruiting
• Start date: March 2015
• Est. completion date: December 2022

Study information

• Verified date: August 2021
• Source: Charite University, Berlin, Germany
• Contact: Julian Hellmann-Regen, MD
• Email: Julian.Hellmann[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcoholism
• Alzheimer Disease
• Alzheimer's Disease
• Major Depression
• Schizophrenia

Locations

Country	Name	City	State
Germany	Department of Psychiatry, Charité - Campus Benjamin Franklin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum retinoic acid (RA) levels [nM]	Serum retinoic acid levels [nM] as determined by HPLC according to previously published protocols	Week 0
Secondary	For MDD group: MADRS	Questionnaire to assess symptom severity in MDD	Week 1, 3, 6
Secondary	For MDD group: BDI II	Self-rating to assess of symptom severity in MDD	Week 1, 3, 6
Secondary	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	Week 1, 3, 6
Secondary	For schizophrenia group: Positive and Negative Syndrome Scale (PANSS) for Schizophrenia	Measurement of symptom severity of patients with schizophrenia	Week 1, 3, 6
Secondary	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	Week 1, 3, 6