Retinoic Acid Homeostasis in Neuropsychiatric Diseases (RAHND)

August 6, 2021 updated by: Julian Hellmann-Regen, Charite University, Berlin, Germany
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Serum retinoic acid (RA) levels [nM]
Time Frame: Week 0
Serum retinoic acid levels [nM] as determined by HPLC according to previously published protocols
Week 0

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
For MDD group: MADRS
Time Frame: Week 1, 3, 6
Questionnaire to assess symptom severity in MDD
Week 1, 3, 6
For MDD group: BDI II
Time Frame: Week 1, 3, 6
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]
Time Frame: Week 1, 3, 6
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
Time Frame: Week 1, 3, 6
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)
Time Frame: Week 1, 3, 6
Assessmant of weight, blood pressure, levels of Glucose, HbA1c, cholesterols and dietry
Week 1, 3, 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charite University, Berlin, Germany

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Isabella Heuser, MD, PhD, Chair: Department of Psychiatry, Charité, CBF

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EA4/002/13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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