Major DepressionRAHNDNCT02439099
Retinoic Acid Homeostasis in Neuropsychiatric Diseases
An observational study of Major Depression and Alzheimer's Disease, run by Charite University, Berlin, Germany at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depression, Alzheimer's Disease, Alcoholism
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2015to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Julian Hellmann-Regen, MD contact
Vera Clemens, MD contact
Germany1 site, 1 recruiting
- Recruiting
Department of Psychiatry, Charité - Campus Benjamin Franklin
Berlin, 12203
About this study
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.
Read the 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.
- Conditions
- Major Depression, Alzheimer's Disease, Alcoholism, Schizophrenia
- Medical subject headings
- Depressive Disorder, Major, Alzheimer Disease, Alcoholism, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MDD | Currently unmedicated patients with a depressive episode in the context of unipolar major depression | |
| Control | Healthy Controls | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Serum retinoic acid (RA) levels [nM]
Serum retinoic acid levels [nM] as determined by HPLC according to previously published protocols
Measured: Week 0
Secondary outcomes (5)
For MDD group: MADRS
Questionnaire to assess symptom severity in MDD
Measured: Week 1, 3, 6
For MDD group: BDI II
Self-rating to assess of symptom severity in MDD
Measured: 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
Measured: Week 1, 3, 6
For schizophrenia group: Positive and Negative Syndrome Scale (PANSS) for Schizophrenia
Measurement of symptom severity of patients with schizophrenia
Measured: 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
Measured: Week 1, 3, 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julian Hellmann-Regen, Charite University, Berlin, Germany
- Investigators
- Isabella Heuser, MD, PhD, Principal investigator, Chair: Department of Psychiatry, Charité, CBF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439099
- Sponsor's protocol ID
- EA4/002/13
- Acronym
- RAHND
- Status last verified
- Aug 2021
- First submitted
- 2 Apr 2015
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinoic Acid Homeostasis in Neuropsychiatric Diseases
- ClinicalTrials.gov ID
- NCT02439099
- Acronym / sponsor ID
- RAHND / EA4/002/13
- Conditions
- Major Depression, Alzheimer's Disease, Alcoholism, Schizophrenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MDD | – | –Currently unmedicated patients with a depressive episode in the context of unipolar major depression |
| Control | – | –Healthy Controls |
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum retinoic acid (RA) levels [nM]
Time frame: Week 0
Serum retinoic acid levels [nM] as determined by HPLC according to previously published protocols
5 secondary outcomes
For MDD group: MADRS
Time frame: Week 1, 3, 6
For MDD group: BDI II
Time frame: Week 1, 3, 6
For MDD and schizophrenia Group: Change of serum retinoic acid (RA) levels [nM]
Time frame: Week 1, 3, 6
For schizophrenia group: Positive and Negative Syndrome Scale (PANSS) for Schizophrenia
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julian Hellmann-Regen, MD contact
Vera Clemens, MD contact
Isabella Heuser, MD, PhD principal investigator
Chair: Department of Psychiatry, Charité, CBF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depression and Alzheimer's Disease, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julian Hellmann-Regen, MD (Julian.Hellmann@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum retinoic acid (RA) levels [nM] (time frame: Week 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.