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Simvastatin add-on Treatment to Standard Antidepressant Therapy in Patients With Comorbid Obesity and Major Depression (SIMCODE)

Primary Purpose

Depressive Disorder, Major, Obesity

Status
Recruiting
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Simvastatin 40mg
Placebo oral tablet
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Written informed consent is present
  • The patient has the capacity to give consent (He/she is able to understand the nature and anticipated effects/side effects of the proposed medical intervention)
  • The patient has a major depressive episode according to DSM 5 (Diagnostic and Statistical Manual of Mental Disorders 5th Edition)
  • The patient has a score of ≥ 18 in the Montgomery-Asberg Depression Rating Scale (MADRS)
  • The patient has a body mass index ≥ 30
  • The patient's age is between 18 and 65 years (≥ 18 und ≤ 65)
  • The patient has not given childbirth within the 6 months prior to study entry and is not breastfeeding
  • In case of non-psychotropic medication: The patient received stable pharmacological medication for at least 14 days prior to study entry (any changes in medication dose or frequency of therapy must be answered with no)
  • The patient did not take antidepressants during the last 7 days prior to study entry (discontinuation of effective medication to enable study participation is prohibited)
  • The patient did not receive prior treatment with Escitalopram in index episode
  • The patient had less than three (<3) trials with antidepressants in index episode
  • The patient does not have a history of non-response to Escitalopram
  • The patient did not receive treatment with ketamine, irreversible MAO inhibitor (e.g. tranylcypromine), electroconvulsive therapy (ECT) or other stimulatory treatments in index episode
  • The patient does not meet any of the following criteria: schizophrenia, schizoaffective disorder, bipolar disorder
  • The patient is not diagnosed with dementia and does not have moderate or severe impairment of general cognitive function according to clinical impression
  • The patient does not have clinically relevant elevated liver enzymes [GOT or GPT > 3 x upper limit normal (ULN)] and does not have elevated Carbohydrate Deficient Transferrin (CDT) ≥ 2.4 %
  • The patient does not meet the criteria for alcohol use disorder (DSM-5: 303.90; ICD-10: F10.20) or substance use disorder (DSM-5: 304; ICD-10: F11.20 - F19.20) in M.I.N.I. for DSM-5 and a urine/serum drug screening is negative (except for benzodiazepines and opiates)
  • The patient does not have a history of suicide attempt
  • The patient does not have diagnosed epilepsy or increased bleeding diathesis or a history of angle closure glaucoma or other glaucomas
  • The patient did not have bariatric surgery prior to study entry
  • The patient does not have a known allergy or contraindication against Escitalopram or Simvastatin
  • The patient does not meet any of the following criteria: hereditary muscle disease, known history of rhabdomyolysis, elevated creatine kinase (CK) outside of the sex-specific reference intervals, history of muscular symptoms under treatment with statins or fibrates
  • The patient does not have elevated TSH level outside of the age- and sex-specific refer-ence intervals.
  • The patient does not have insulin-dependent diabetes mellitus
  • The patient does not have uncontrolled hepatic disorder, renal or cardiovascular disease
  • The patient does not have untreated hypothyroidism
  • The patient does not have a history of myocardial infarction or stroke
  • The patient does not have symptomatic peripheral arterial disease
  • The patient does not have monogenic familial hypercholesterolemia
  • The patient does not have clinically significant laboratory abnormalities
  • The patient did not participate in other interventional trials during the 6 months before and at the time of this trial
  • The patient is not an employee of the investigator study site, or a family member of the employees or the investigator, or otherwise dependent on the sponsor, the investigator or the investigator study site

Exclusion Criteria:

  • The patient has current use of statins (for visits 2-6 applies: except for IMP Simvastatin)
  • The patient has current use of antidepressants (for visits 2-6 applies: except for standard medication Escitalopram)
  • The patient has acute suicidal tendencies (MADRS Item 10 > 4)
  • The patient uses potent CYP3A4-inhibitors (e.g. clarithromycin, erythromycin, HIV protease inhibitors - see "Risks, adverse drug reactions, drug interactions, restrictions, contraindications, procedures in case of emergency")
  • The patient uses potent CYP3A4 inductors (Carbamazepine, Efavirenz, Nevirapine, Etravirine).
  • The patient uses Fibrates, Amiodarone, Amlodipine, Verapamil, Fluconazol, Diltiazem, Fusidic acid, Niacin or Lomitapide or BCRP-Inhibitors (e.g. Elbasvir or Grazoprevir)
  • The patient uses Gemfibrozil, Ciclosporin or Danazol
  • The patient has known hypersensitivity to other ingredients of Simvastatin and Escitalopram [butylated hydroxyanisole, microcrystalline celluose, citric acid, starch, lactose, magnesium stearate, hypromellose, talc, titanium dioxide, iron oxides, colloidal silicon dioxide, croscarmellose sodium, polyethylene glycol]
  • The patient uses medication that is associated with QTc-prolongation [antiarrhythmics class IA and III, antipsychotics (e.g. Haloperidol), phenothiazines, tricyclic antidepressants, antibiotics (e.g. Moxifloxacin), and certain antihistaminergic drugs (e.g. Astemizol, Mizolastine)]
  • The patient has clinically significant abnormalities in 12-lead ECG (e.g. QTc-prolongation ≥ 500 ms or increase ≥ 60 ms from baseline visit)
  • The patient is pregnant
  • The patient with childbearing potential is not willing to use an acceptable form of contraception (defined as Pearl index < 1)
  • The patient has current use of psychotropic medication (e.g. antipsychotics, anticonvulsants, lithium or St. John's Wort) except for benzodiazepines, non-benzodiazepines and opiates
  • The patient uses nonselective, irreversible monoamine oxidase (MAO) inhibitor (e.g. Tranylcypromine) or selective, reversible inhibitor of monoamine oxidase A (e.g. Moclobemide) or the nonselective, reversible monoamine oxidase inhibitor Linezolid
  • The patient is unwilling to consent to saving, processing and propagation of pseudonymized medical data for study reasons
  • The patient is legally detained in an official institution

Sites / Locations

  • Charité - Universitätsmedizin Berlin, Klinik für Psychiatrie und PsychotherapieRecruiting
  • Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt PsychosomatikRecruiting
  • Universitätsklinikum Frankfurt, Klinik für Psychiatrie, Psychosomatik und PsychotherapieRecruiting
  • Universitätsmedizin Greifswald, Klinik und Poliklinik für Psychiatrie und PsychotherapieRecruiting
  • Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Psychiatrie und PsychotherapieRecruiting
  • Medizinische Hochschule Hannover, Klinik für Psychiatrie, Sozialpsychiatrie und Psychotherapie
  • Universitätsklinikum Leipzig, Klinik und Poliklinik für Psychiatrie und PsychotherapieRecruiting
  • Universitätsklinikum Schleswig-Holstein, Zentrum für Integrative Psychiatrie - Klinik für Psychiatrie und Psychotherapie
  • Helios Hanseklinikum Stralsund Klinik und Poliklinik für Psychiatrie, Psychotherapie und PsychosomatikRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Simvastatin

Placebo

Arm Description

Simvastatin and Escitalopram

Placebo and Escitalopram

Outcomes

Primary Outcome Measures

Change score in MADRS (Montgomery-Asberg-Depression Rating Scale)
The MADRS is a rating scale to measure depression severity. Each MADRS item is rated on a 0 to 6 scale. Total score range from 0-60, where higher MADRS scores indicate higher levels of depressive symptoms.

Secondary Outcome Measures

MADRS-response
Response is defined as 50% MADRS score reduction at week 12 from baseline.
MADRS-remission
Remission is defined as a MADRS score less than 10 at week 12.
MADRS-MCID
MADRS Minimal Clinically Important Difference represents the smallest improvement that is considered meaningful by the patient. Empirically, the MCID using the MADRS has been identified as a change from baseline between 1.6 - 1.9 at week 12.
Change score in BDI-II (Beck Depression Inventory-II)
The Beck Depression Inventory-II (BDI-II) is a 21-item validated instrument for the self-report of depressive symptoms, with individual item scores summed to yield a total possible BDI score that ranges from 0-63. BDI scores from 0-13 suggest absent to minimal depressive symptoms, from 14-19 mild symptoms, from 20-28 moderate symptoms, and from 29-63 severe symptoms.
BDI-II-MCID
BDI-II Minimal Clinically Important Difference represents the smallest improvement that is considered meaningful by the patient.
Change score in PGIC (Patients' Global Impression of Change Scale)
Participant rated instrument to measure participant's change in overall status on a scale of 0 to 7; range from 1 (very much improved) to 7 (very much worse).
Change score in CGI-S (Clinicians' Global Impression of Severity of Illness)
The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The CGI-S permits a global evaluation of the participant's condition at a given time.
CGI-I (Clinicians' Global Impression of Improvement )
Clinician rated instrument to measure clinicians' change in overall status on a scale of 0 to 7; range from 1 (very much improved) to 7 (very much worse).
EQ-5D-3L (EuroQol-5 Dimensions-3 Levels Questionnaire)
Generic instrument of quality of life related to health. It contains five dimensions of health (mobility, personal care, daily activities, pain / discomfort and anxiety / depression) and each of them has three levels of seriousness (without problems, some problems or moderate problems and serious problems). The second part of the EQ-5D is a Visual Analogue Scale (VAS) of 20 centimeters, millimeter, ranging from 0 (worse health status imaginable) to 100 (best imaginable health status). In it, the individual must mark the point in the vertical line that best reflects the assessment of their global health status today.
SOFAS (Social and Occupational Functioning Assessment Scale)
The SOFAS is a rating scale used to determine social functioning; range from 0-100. A higher score represents a better outcome.

Full Information

First Posted
March 6, 2020
Last Updated
May 16, 2023
Sponsor
Charite University, Berlin, Germany
Collaborators
NeuroCure Clinical Research Center, Charite, Berlin, University Medical Center Goettingen
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1. Study Identification

Unique Protocol Identification Number
NCT04301271
Brief Title
Simvastatin add-on Treatment to Standard Antidepressant Therapy in Patients With Comorbid Obesity and Major Depression
Acronym
SIMCODE
Official Title
Simvastatin add-on to Escitalopram in Patients With Comorbid Obesity and Major Depression: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 13, 2020 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
NeuroCure Clinical Research Center, Charite, Berlin, University Medical Center Goettingen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Major depressive disorder (MDD) and obesity are major contributors to impaired health worldwide. Statins are among the most prescribed medications with well-established safety and efficacy. Statins are recommended in primary prevention of cardiovascular disease, which has been linked to both MDD and obesity. Moreover, statins are promising candidates to treat MDD because a meta-analysis of pilot randomized controlled trials has found antidepressive effects of statins as adjunct therapy to antidepressants. However, no study so far has tested the antidepressive potential of statins in patients with MDD and comorbid obesity. Therefore, we hypothesize that Simvastatin add-on to standard antidepressant Escitalopram will improve depression to a greater extent than add-on placebo in patients with comorbid obesity and major depression. We will randomize 160 obese MDD patients at 8 recruiting centers to either Simvastatin or placebo as add-on to Escitalopram for 12 weeks. If successful, our trial would have immediate impact on clinical practice given the fact that Simvastatin and Escitalopram are available as inexpensive generic drugs with established safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Simvastatin
Arm Type
Experimental
Arm Description
Simvastatin and Escitalopram
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo and Escitalopram
Intervention Type
Drug
Intervention Name(s)
Simvastatin 40mg
Other Intervention Name(s)
Zocor, C10AA01
Intervention Description
12 weeks 40 mg Simvastatin add-on
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
12 weeks Placebo add-on
Primary Outcome Measure Information:
Title
Change score in MADRS (Montgomery-Asberg-Depression Rating Scale)
Description
The MADRS is a rating scale to measure depression severity. Each MADRS item is rated on a 0 to 6 scale. Total score range from 0-60, where higher MADRS scores indicate higher levels of depressive symptoms.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
MADRS-response
Description
Response is defined as 50% MADRS score reduction at week 12 from baseline.
Time Frame
12 weeks
Title
MADRS-remission
Description
Remission is defined as a MADRS score less than 10 at week 12.
Time Frame
12 weeks
Title
MADRS-MCID
Description
MADRS Minimal Clinically Important Difference represents the smallest improvement that is considered meaningful by the patient. Empirically, the MCID using the MADRS has been identified as a change from baseline between 1.6 - 1.9 at week 12.
Time Frame
12 weeks
Title
Change score in BDI-II (Beck Depression Inventory-II)
Description
The Beck Depression Inventory-II (BDI-II) is a 21-item validated instrument for the self-report of depressive symptoms, with individual item scores summed to yield a total possible BDI score that ranges from 0-63. BDI scores from 0-13 suggest absent to minimal depressive symptoms, from 14-19 mild symptoms, from 20-28 moderate symptoms, and from 29-63 severe symptoms.
Time Frame
12 weeks
Title
BDI-II-MCID
Description
BDI-II Minimal Clinically Important Difference represents the smallest improvement that is considered meaningful by the patient.
Time Frame
12 weeks
Title
Change score in PGIC (Patients' Global Impression of Change Scale)
Description
Participant rated instrument to measure participant's change in overall status on a scale of 0 to 7; range from 1 (very much improved) to 7 (very much worse).
Time Frame
12 weeks
Title
Change score in CGI-S (Clinicians' Global Impression of Severity of Illness)
Description
The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The CGI-S permits a global evaluation of the participant's condition at a given time.
Time Frame
12 weeks
Title
CGI-I (Clinicians' Global Impression of Improvement )
Description
Clinician rated instrument to measure clinicians' change in overall status on a scale of 0 to 7; range from 1 (very much improved) to 7 (very much worse).
Time Frame
12 weeks
Title
EQ-5D-3L (EuroQol-5 Dimensions-3 Levels Questionnaire)
Description
Generic instrument of quality of life related to health. It contains five dimensions of health (mobility, personal care, daily activities, pain / discomfort and anxiety / depression) and each of them has three levels of seriousness (without problems, some problems or moderate problems and serious problems). The second part of the EQ-5D is a Visual Analogue Scale (VAS) of 20 centimeters, millimeter, ranging from 0 (worse health status imaginable) to 100 (best imaginable health status). In it, the individual must mark the point in the vertical line that best reflects the assessment of their global health status today.
Time Frame
12 weeks
Title
SOFAS (Social and Occupational Functioning Assessment Scale)
Description
The SOFAS is a rating scale used to determine social functioning; range from 0-100. A higher score represents a better outcome.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent is present The patient has the capacity to give consent (He/she is able to understand the nature and anticipated effects/side effects of the proposed medical intervention) The patient has a major depressive episode according to DSM 5 (Diagnostic and Statistical Manual of Mental Disorders 5th Edition) The patient has a score of ≥ 18 in the Montgomery-Asberg Depression Rating Scale (MADRS) The patient has a body mass index ≥ 30 The patient's age is between 18 and 65 years (≥ 18 und ≤ 65) The patient has not given childbirth within the 6 months prior to study entry and is not breastfeeding In case of non-psychotropic medication: The patient received stable pharmacological medication for at least 14 days prior to study entry (any changes in medication dose or frequency of therapy must be answered with no) The patient did not take antidepressants during the last 7 days prior to study entry (discontinuation of effective medication to enable study participation is prohibited) The patient did not receive prior treatment with Escitalopram in index episode The patient had less than three (<3) trials with antidepressants in index episode The patient does not have a history of non-response to Escitalopram The patient did not receive treatment with ketamine, irreversible MAO inhibitor (e.g. tranylcypromine), electroconvulsive therapy (ECT) or other stimulatory treatments in index episode The patient does not meet any of the following criteria: schizophrenia, schizoaffective disorder, bipolar disorder The patient is not diagnosed with dementia and does not have moderate or severe impairment of general cognitive function according to clinical impression The patient does not have clinically relevant elevated liver enzymes [GOT or GPT > 3 x upper limit normal (ULN)] and does not have elevated Carbohydrate Deficient Transferrin (CDT) ≥ 2.4 % The patient does not meet the criteria for alcohol use disorder (DSM-5: 303.90; ICD-10: F10.20) or substance use disorder (DSM-5: 304; ICD-10: F11.20 - F19.20) in M.I.N.I. for DSM-5 and a urine/serum drug screening is negative (except for benzodiazepines and opiates) The patient does not have a history of suicide attempt The patient does not have diagnosed epilepsy or increased bleeding diathesis or a history of angle closure glaucoma or other glaucomas The patient did not have bariatric surgery prior to study entry The patient does not have a known allergy or contraindication against Escitalopram or Simvastatin The patient does not meet any of the following criteria: hereditary muscle disease, known history of rhabdomyolysis, elevated creatine kinase (CK) outside of the sex-specific reference intervals, history of muscular symptoms under treatment with statins or fibrates The patient does not have elevated TSH level outside of the age- and sex-specific refer-ence intervals. The patient does not have insulin-dependent diabetes mellitus The patient does not have uncontrolled hepatic disorder, renal or cardiovascular disease The patient does not have untreated hypothyroidism The patient does not have a history of myocardial infarction or stroke The patient does not have symptomatic peripheral arterial disease The patient does not have monogenic familial hypercholesterolemia The patient does not have clinically significant laboratory abnormalities The patient did not participate in other interventional trials during the 6 months before and at the time of this trial The patient is not an employee of the investigator study site, or a family member of the employees or the investigator, or otherwise dependent on the sponsor, the investigator or the investigator study site Exclusion Criteria: The patient has current use of statins (for visits 2-6 applies: except for IMP Simvastatin) The patient has current use of antidepressants (for visits 2-6 applies: except for standard medication Escitalopram) The patient has acute suicidal tendencies (MADRS Item 10 > 4) The patient uses potent CYP3A4-inhibitors (e.g. clarithromycin, erythromycin, HIV protease inhibitors - see "Risks, adverse drug reactions, drug interactions, restrictions, contraindications, procedures in case of emergency") The patient uses potent CYP3A4 inductors (Carbamazepine, Efavirenz, Nevirapine, Etravirine). The patient uses Fibrates, Amiodarone, Amlodipine, Verapamil, Fluconazol, Diltiazem, Fusidic acid, Niacin or Lomitapide or BCRP-Inhibitors (e.g. Elbasvir or Grazoprevir) The patient uses Gemfibrozil, Ciclosporin or Danazol The patient has known hypersensitivity to other ingredients of Simvastatin and Escitalopram [butylated hydroxyanisole, microcrystalline celluose, citric acid, starch, lactose, magnesium stearate, hypromellose, talc, titanium dioxide, iron oxides, colloidal silicon dioxide, croscarmellose sodium, polyethylene glycol] The patient uses medication that is associated with QTc-prolongation [antiarrhythmics class IA and III, antipsychotics (e.g. Haloperidol), phenothiazines, tricyclic antidepressants, antibiotics (e.g. Moxifloxacin), and certain antihistaminergic drugs (e.g. Astemizol, Mizolastine)] The patient has clinically significant abnormalities in 12-lead ECG (e.g. QTc-prolongation ≥ 500 ms or increase ≥ 60 ms from baseline visit) The patient is pregnant The patient with childbearing potential is not willing to use an acceptable form of contraception (defined as Pearl index < 1) The patient has current use of psychotropic medication (e.g. antipsychotics, anticonvulsants, lithium or St. John's Wort) except for benzodiazepines, non-benzodiazepines and opiates The patient uses nonselective, irreversible monoamine oxidase (MAO) inhibitor (e.g. Tranylcypromine) or selective, reversible inhibitor of monoamine oxidase A (e.g. Moclobemide) or the nonselective, reversible monoamine oxidase inhibitor Linezolid The patient is unwilling to consent to saving, processing and propagation of pseudonymized medical data for study reasons The patient is legally detained in an official institution
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Otte, MD
Phone
0049 30 450 617615
Email
christian.otte@charite.de
First Name & Middle Initial & Last Name or Official Title & Degree
Woo Ri Chae, MD
Email
woo-ri.chae@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Otte, MD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité - Universitätsmedizin Berlin, Klinik für Psychiatrie und Psychotherapie
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Otte, MD
First Name & Middle Initial & Last Name & Degree
Stefan Röpke, MD
Facility Name
Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Psychosomatik
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Hinkelmann, MD
First Name & Middle Initial & Last Name & Degree
Tobias Hofmann, MD
Facility Name
Universitätsklinikum Frankfurt, Klinik für Psychiatrie, Psychosomatik und Psychotherapie
City
Frankfurt
ZIP/Postal Code
60528
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Reif, MD
First Name & Middle Initial & Last Name & Degree
David Prvulovic, MD
Facility Name
Universitätsmedizin Greifswald, Klinik und Poliklinik für Psychiatrie und Psychotherapie
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans J Grabe, MD
First Name & Middle Initial & Last Name & Degree
Deborah Janowitz, MD
Facility Name
Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Psychiatrie und Psychotherapie
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregor Leicht, MD
First Name & Middle Initial & Last Name & Degree
Daniel Schöttle, MD
Facility Name
Medizinische Hochschule Hannover, Klinik für Psychiatrie, Sozialpsychiatrie und Psychotherapie
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai G Kahl, MD
First Name & Middle Initial & Last Name & Degree
Tillmann Krüger, MD
Facility Name
Universitätsklinikum Leipzig, Klinik und Poliklinik für Psychiatrie und Psychotherapie
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Strauß, MD
First Name & Middle Initial & Last Name & Degree
Barbara Ettrich, MD
Facility Name
Universitätsklinikum Schleswig-Holstein, Zentrum für Integrative Psychiatrie - Klinik für Psychiatrie und Psychotherapie
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philipp Klein, MD
First Name & Middle Initial & Last Name & Degree
Klaus Junghanns, MD
Facility Name
Helios Hanseklinikum Stralsund Klinik und Poliklinik für Psychiatrie, Psychotherapie und Psychosomatik
City
Stralsund
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Janowitz, MD
First Name & Middle Initial & Last Name & Degree
Robert Fleischmann, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33262189
Citation
Otte C, Chae WR, Nowacki J, Kaczmarczyk M, Piber D, Roepke S, Marschenz S, Lischewski S, Schmidt S, Ettrich B, Grabe HJ, Hegerl U, Hinkelmann K, Hofmann T, Janowitz D, Junghanns K, Kahl KG, Klein JP, Krueger THC, Leicht G, Prvulovic D, Reif A, Schoettle D, Strauss M, Westermair A, Friede T, Gold SM. Simvastatin add-on to escitalopram in patients with comorbid obesity and major depression (SIMCODE): study protocol of a multicentre, randomised, double-blind, placebo-controlled trial. BMJ Open. 2020 Dec 1;10(12):e040119. doi: 10.1136/bmjopen-2020-040119.
Results Reference
derived

Learn more about this trial

Simvastatin add-on Treatment to Standard Antidepressant Therapy in Patients With Comorbid Obesity and Major Depression

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