Retinoic Acid Homeostasis in Neuropsychiatric Diseases (RAHND)

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.

Study Overview

• Status: Recruiting
• Conditions: Alcoholism; Schizophrenia; Major Depression; Alzheimer's Disease

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Julian Hellmann-Regen, MD; Email: Julian.Hellmann@charite.de
• Study Contact Backup: Name: Vera Clemens, MD; Email: Vera.Clemens@charite.com

Study Locations

• Germany
  • Berlin, Germany, 12203
    • Recruiting
    • Department of Psychiatry, Charité - Campus Benjamin Franklin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
Control; Healthy Controls
MDD; Currently unmedicated patients with a depressive episode in the context of unipolar major depression
Alzheimer's Disease; Patients with Alzheimer's disease
Alcoholism; Subjects with alcoholism
Schizophrenia; Subjects with before and schizophrenia prior to and during medication with clozapine, olanzapine or aripiprazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum retinoic acid (RA) levels [nM]	Serum retinoic acid levels [nM] as determined by HPLC according to previously published protocols	Week 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
For MDD group: MADRS	Questionnaire to assess symptom severity in MDD	Week 1, 3, 6
For MDD group: BDI II	Self-rating to assess of symptom severity in MDD	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	Week 1, 3, 6
For schizophrenia group: Positive and Negative Syndrome Scale (PANSS) for Schizophrenia	Measurement of symptom severity of patients with schizophrenia	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	Week 1, 3, 6

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Isabella Heuser, MD, PhD, Chair: Department of Psychiatry, Charité, CBF

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: April 2, 2015
• First Submitted That Met QC Criteria: May 7, 2015
• First Posted (Estimate): May 8, 2015

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 6, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Alcohol-Related Disorders; Substance-Related Disorders; Neurocognitive Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alcoholism; Schizophrenia; Alzheimer Disease
• Other Study ID Numbers: EA4/002/13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No