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Retinoic Acid Homeostasis in Neuropsychiatric Diseases

Retinoic Acid Homeostasis in Neuropsychiatric Diseases

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02439099
Acronym
RAHND
Enrollment
200
Registered
2015-05-08
Start date
2015-03-31
Completion date
2022-12-31
Last updated
2021-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholism, Alzheimer's Disease, Major Depression, Schizophrenia

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.

Interventions

None listed

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Serum retinoic acid (RA) levels [nM]Week 0Serum retinoic acid levels \[nM\] as determined by HPLC according to previously published protocols

Secondary

MeasureTime frameDescription
For MDD group: MADRSWeek 1, 3, 6Questionnaire to assess symptom severity in MDD
For MDD group: BDI IIWeek 1, 3, 6Self-rating to assess of symptom severity in MDD
For MDD and schizophrenia Group: Change of serum retinoic acid (RA) levels [nM]Week 1, 3, 6Serum retinoic acid levels \[nM\] as determined by HPLC according to previously published protocols
For schizophrenia group: Positive and Negative Syndrome Scale (PANSS) for SchizophreniaWeek 1, 3, 6Measurement of symptom severity of patients with schizophrenia
For schizophrenia group: Change of metabolic parametres For schizophrenia group:Positive and Negative Syndrome Scale (PANSS)Week 1, 3, 6Assessmant of weight, blood pressure, levels of Glucose, HbA1c, cholesterols and dietry

Countries

Germany

Contacts

Primary ContactJulian Hellmann-Regen, MD
Julian.Hellmann@charite.de
Backup ContactVera Clemens, MD
Vera.Clemens@charite.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026