Retinoic Acid Homeostasis in Neuropsychiatric Diseases

NCT ID: NCT02439099

Last Updated: 2021-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Major Depression Alzheimer's Disease Alcoholism Schizophrenia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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MDD

Currently unmedicated patients with a depressive episode in the context of unipolar major depression

No interventions assigned to this group

Control

Healthy Controls

No interventions assigned to this group

Alzheimer's Disease

Patients with Alzheimer's disease

No interventions assigned to this group

Alcoholism

Subjects with alcoholism

No interventions assigned to this group

Schizophrenia

Subjects with before and schizophrenia prior to and during medication with clozapine, olanzapine or aripiprazole

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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


* diagnosed AD


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


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

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


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

Schizophrenia-Group


* 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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Julian Hellmann-Regen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Isabella Heuser, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chair: Department of Psychiatry, Charité, CBF

Locations

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Department of Psychiatry, Charité - Campus Benjamin Franklin

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Julian Hellmann-Regen, MD

Role: CONTACT

Vera Clemens, MD

Role: CONTACT

Other Identifiers

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EA4/002/13

Identifier Type: -

Identifier Source: org_study_id

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