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    Clinical Trial Results:
    Simvastatin add-on to Escitalopram in patients with comorbid obesity and major depression: A multicenter, randomized, double-blind, placebo-controlled trial

    Summary
    EudraCT number
    		 2018-002947-27
    Trial protocol
    		 DE  
    Global end of trial date
    06 Jun 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Aug 2025
    First version publication date
    23 Aug 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SIMCODE
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04301271
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Charité - Universitätsmedizin Berlin
    Sponsor organisation address
    Chariteplatz 1, Berlin, Germany, 10117
    Public contact
    Klinik für Psychiatrie und Psychotherapie Prof. Dr. Christian Otte, Charité – Universitätsmedizin Berlin, +49 30450 517531, simcode-studie@charite.de
    Scientific contact
    Klinik für Psychiatrie und Psychotherapie Prof. Dr. Christian Otte, Charité – Universitätsmedizin Berlin, +49 30450 517531, simcode-studie@charite.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Jul 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Jun 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jun 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To examine whether add-on 40 mg/d Simvastatin to standard antidepressant medication (Escitalopram 20 mg/d) improves depression to a greater extent than adjunct placebo in patients with major depression and comorbid obesity
    Protection of trial subjects
    The conduct of this study met all legal and regulatory current requirements (current ICH-GCP-guidelines) and in accordance with ethical principles of the Declaration of Helsinki.
    Background therapy
    		 Major depressive disorder (MDD) and obesity are both linked to a higher risk of cardiovascular disease and stroke, further increasing their public health and economic impact. Importantly, MDD and obesity frequently co-occur and the presence of one condition increases the risk for developing the other. Statins (3-hydroxy-3-methylglutaryl Co-A reductase inhibitors) are among the most prescribed medications worldwide with well-established safety and efficacy. Recent guidelines recommend use of statins in primary prevention of cardiovascular disease, which has been linked to both MDD and obesity. However, no randomized controlled study so far has tested the antidepressive potential of statins in patients with MDD and comorbid obesity. Importantly, this is a difficult-to-treat population that often exhibits a chronic course of MDD and treatment resistance.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Mar 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 160
    Worldwide total number of subjects
    160
    EEA total number of subjects
    160
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    160
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 9 study center in Germany between 05/09/2020 and 05/06/2024. Recruitment start / start of study: (first patient first visit) Q1 2020 – postponed due to COVID-19 pandemic to Q3 2020

    Pre-assignment
    Screening details
    		 211 have been screened according the inclusion and exclusion criteria and 161 patients with comorbid obesity (body mass index ≥ 30) and major depression have been randomized.1 Excluded after randomization because of consent withdrawn.

    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Simvastatin + Escitalopram
    Arm description
    		 Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, Simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β -hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin belongs to the statin class of medications, which are used to lower the risk of cardiovascular disease and manage abnormal lipid levels by inhibiting the endogenous production of cholesterol in the liver.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Simvastatin
    Investigational medicinal product code
    C10AA01
    Other name
    CAS 79902-63-9, SimvaHexal, MAN 52531.04.00
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Fixed dose 40 mg/d without adjustment, orally once daily at bedtime over 12 weeks. It was be provided as add-on medication to standard antidepressant treatment [Escitalopram (fixed dose 10 mg/d week 1 - 2 and 20 mg/d week 3 - 12)].

    Investigational medicinal product name
    Escitalopram
    Investigational medicinal product code
    N06AB10
    Other name
    CAS 219861-08-2, CIPRALEX, MAN 55880.03.00 (08.April 2003)
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    placebo will be provided as add-on medication to standard antidepressant treatment with Escitalopram. Fixed dose of Escitalopram 10 mg/d in first two weeks, then increase to 20 mg/d oral film-coated tablets.

    Arm title
    		 Placebo + Escitalopram
    Arm description
    		 Escitalopram is a selective inhibitor of serotonin (5-HT) re-uptake with high affinity for the primary binding site. It also binds to an allosteric site on the serotonin transporter, with a 1000 fold lower affinity. Escitalopram has no or low affinity for a number of receptors including 5-HT1A, 5-HT2, DA D1 and D2 receptors, α1-, α2-, β-adrenoceptors, histamine H1, muscarine cholinergic, benzodiazepine, and opioid receptors.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Escitalopram
    Investigational medicinal product code
    N06AB10
    Other name
    CAS 219861-08-2
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Fixed dose of Escitalopram 10 mg/d in first two weeks, then increase to 20 mg/d oral film-coated tablets. Tablet core: Microcrystalline cellulose, Colloidal anhydrous silica, Talc, Croscarmellose sodium, Magnesium stearate. Film coating: Hypromellose 6cP (E464), Titanium dioxide (E171), Macrogol 3000

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Based on the randomization codes, the pharmacy centrally provided for each center sequentially numbered, tamper-proof containers, which are equal in weight and similar in appearance containing IMP or placebo. Tablet core: Microcrystalline cellulose, Colloidal anhydrous silica, Talc, Croscarmellose sodium, Magnesium stearate. Film coating: Hypromellose 6cP (E464), Titanium dioxide (E171), Macrogol 3000

    Number of subjects in period 1
    		Simvastatin + Escitalopram Placebo + Escitalopram
    Started
    81
    79
    Completed
    81
    79

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Simvastatin + Escitalopram
    Reporting group description
    		 Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, Simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β -hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin belongs to the statin class of medications, which are used to lower the risk of cardiovascular disease and manage abnormal lipid levels by inhibiting the endogenous production of cholesterol in the liver.

    Reporting group title
    Placebo + Escitalopram
    Reporting group description
    		 Escitalopram is a selective inhibitor of serotonin (5-HT) re-uptake with high affinity for the primary binding site. It also binds to an allosteric site on the serotonin transporter, with a 1000 fold lower affinity. Escitalopram has no or low affinity for a number of receptors including 5-HT1A, 5-HT2, DA D1 and D2 receptors, α1-, α2-, β-adrenoceptors, histamine H1, muscarine cholinergic, benzodiazepine, and opioid receptors.

    Reporting group values
    		 Simvastatin + Escitalopram Placebo + Escitalopram Total
    Number of subjects
    		 81 79 160
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 81 79 160
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 39 (20 to 64) 39 (19 to 63) -
    Gender categorical
    Units: Subjects
        Female
    		 63 63 126
        Male
    		 18 16 34
    Chronic depression
    Chronic depression was defined as duration of current depressive episode for 104 weeks or longer.
    Units: Subjects
        no
    		 64 56 120
        yes
    		 12 15 27
        no records
    		 5 8 13
    Hypertension
    Units: Subjects
        no
    		 24 19 43
        yes
    		 57 60 117
    LDL >100mg/dL
    Units: Subjects
        no
    		 17 18 35
        yes
    		 62 60 122
        no records
    		 2 1 3
    Body Mass Index
    Body mass index is calculated as weight in kilograms divided by height in meters squared.
    Units: score
        median (inter-quartile range (Q1-Q3))
    		 38.7 (33.5 to 43.1) 37.6 (34.7 to 41.4) -
    MADRS
    MADRS = Montgomery-Åsberg DepressionvRating Scale
    Units: score
        arithmetic mean (standard deviation)
    		 25.8 ( 4.8 ) 25.2 ( 5.2 ) -
    Duration of current episode
    Units: week
        median (inter-quartile range (Q1-Q3))
    		 27 (16 to 53) 40 (20 to 82) -

    End points

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    End points reporting groups
    Reporting group title
    Simvastatin + Escitalopram
    Reporting group description
    		 Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, Simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β -hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin belongs to the statin class of medications, which are used to lower the risk of cardiovascular disease and manage abnormal lipid levels by inhibiting the endogenous production of cholesterol in the liver.

    Reporting group title
    Placebo + Escitalopram
    Reporting group description
    		 Escitalopram is a selective inhibitor of serotonin (5-HT) re-uptake with high affinity for the primary binding site. It also binds to an allosteric site on the serotonin transporter, with a 1000 fold lower affinity. Escitalopram has no or low affinity for a number of receptors including 5-HT1A, 5-HT2, DA D1 and D2 receptors, α1-, α2-, β-adrenoceptors, histamine H1, muscarine cholinergic, benzodiazepine, and opioid receptors.

    Primary: Change score in MADRS

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    End point title
    		 Change score in MADRS
    End point description
    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.
    End point type
    Primary
    End point timeframe
    12 weeks
    End point values
    		 Simvastatin + Escitalopram Placebo + Escitalopram
    Number of subjects analysed
    81
    79
    Units: score
        arithmetic mean (standard deviation)
    12 ( 8 )
    12 ( 9 )
    Statistical analysis title
    		 Sensitivity analyses MADRS
    Comparison groups
    Simvastatin + Escitalopram v Placebo + Escitalopram
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.71
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.08
         upper limit
    		 3.02
    Variability estimate
    Standard deviation

    Secondary: change LDL

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    End point title
    		 change LDL
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Simvastatin + Escitalopram Placebo + Escitalopram
    Number of subjects analysed
    81
    79
    Units: mg/dl
        arithmetic mean (standard deviation)
    87 ( 35 )
    120 ( 31 )
    Statistical analysis title
    		 exploratory analysis
    Comparison groups
    Simvastatin + Escitalopram v Placebo + Escitalopram
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.39
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    overall study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Placebo + Escitalopram
    Reporting group description
    		 -

    Reporting group title
    Simvastatin + Escitalopram
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo + Escitalopram Simvastatin + Escitalopram
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 81 (1.23%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Surgical and medical procedures
    Surgical and medical procedures - Other, specify
    Additional description: Curretage
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy, puerperium and perinatal conditions - Other, specify
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy loss
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Placebo + Escitalopram Simvastatin + Escitalopram
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    43 / 79 (54.43%)
    62 / 81 (76.54%)
    General disorders and administration site conditions
    polydipsia
         subjects affected / exposed
    2 / 79 (2.53%)
    1 / 81 (1.23%)
         occurrences all number
    2
    1
    Flu like symptoms
         subjects affected / exposed
    9 / 79 (11.39%)
    7 / 81 (8.64%)
         occurrences all number
    9
    8
    Fatigue/ Malaise
         subjects affected / exposed
    10 / 79 (12.66%)
    10 / 81 (12.35%)
         occurrences all number
    10
    11
    Reproductive system and breast disorders
    sexual dysfunction
         subjects affected / exposed
    2 / 79 (2.53%)
    7 / 81 (8.64%)
         occurrences all number
    2
    7
    Irregular menstruation
         subjects affected / exposed
    1 / 79 (1.27%)
    2 / 81 (2.47%)
         occurrences all number
    1
    2
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    2 / 79 (2.53%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Psychiatric disorders
    Libido decreased
         subjects affected / exposed
    2 / 79 (2.53%)
    2 / 81 (2.47%)
         occurrences all number
    2
    3
    Insomnia
         subjects affected / exposed
    6 / 79 (7.59%)
    4 / 81 (4.94%)
         occurrences all number
    6
    4
    Restlessness
         subjects affected / exposed
    7 / 79 (8.86%)
    6 / 81 (7.41%)
         occurrences all number
    8
    7
    Investigations
    CPK increased
         subjects affected / exposed
    7 / 79 (8.86%)
    5 / 81 (6.17%)
         occurrences all number
    7
    5
    ALT /GPT increased
         subjects affected / exposed
    3 / 79 (3.80%)
    2 / 81 (2.47%)
         occurrences all number
    3
    2
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 79 (0.00%)
    3 / 81 (3.70%)
         occurrences all number
    0
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    20 / 79 (25.32%)
    23 / 81 (28.40%)
         occurrences all number
    20
    23
    Migraine
         subjects affected / exposed
    0 / 79 (0.00%)
    2 / 81 (2.47%)
         occurrences all number
    0
    2
    Restless legs syndrome
         subjects affected / exposed
    2 / 79 (2.53%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Tremor
         subjects affected / exposed
    3 / 79 (3.80%)
    2 / 81 (2.47%)
         occurrences all number
    3
    2
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    6 / 79 (7.59%)
    10 / 81 (12.35%)
         occurrences all number
    6
    10
    Eye disorders
    Blurred vision
         subjects affected / exposed
    2 / 79 (2.53%)
    1 / 81 (1.23%)
         occurrences all number
    2
    1
    Gastrointestinal disorders
    diarrhea
         subjects affected / exposed
    9 / 79 (11.39%)
    7 / 81 (8.64%)
         occurrences all number
    10
    8
    Vomiting
         subjects affected / exposed
    3 / 79 (3.80%)
    5 / 81 (6.17%)
         occurrences all number
    3
    5
    Gastrointestinal pain
         subjects affected / exposed
    2 / 79 (2.53%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Dry mouth
         subjects affected / exposed
    1 / 79 (1.27%)
    3 / 81 (3.70%)
         occurrences all number
    1
    3
    Nausea
         subjects affected / exposed
    12 / 79 (15.19%)
    17 / 81 (20.99%)
         occurrences all number
    12
    17
    Constipation
         subjects affected / exposed
    5 / 79 (6.33%)
    1 / 81 (1.23%)
         occurrences all number
    5
    1
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    7 / 79 (8.86%)
    3 / 81 (3.70%)
         occurrences all number
    8
    3
    Urticaria
         subjects affected / exposed
    3 / 79 (3.80%)
    1 / 81 (1.23%)
         occurrences all number
    3
    1
    Musculoskeletal and connective tissue disorders
    muscle ache/neck pain
         subjects affected / exposed
    4 / 79 (5.06%)
    2 / 81 (2.47%)
         occurrences all number
    4
    2
    back pain/ lumbago
         subjects affected / exposed
    2 / 79 (2.53%)
    3 / 81 (3.70%)
         occurrences all number
    2
    3
    Infections and infestations
    COVID-19
         subjects affected / exposed
    3 / 79 (3.80%)
    1 / 81 (1.23%)
         occurrences all number
    3
    1
    Upper respiratory tract infection
    Additional description: Tonsillitis/Sinusitis
         subjects affected / exposed
    2 / 79 (2.53%)
    1 / 81 (1.23%)
         occurrences all number
    2
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jun 2021
    update protocol Version 1.3. dated 26/05/2021 and PICF dated 11/05/2021; Change in inclusion criteria, change in cancellation criteria
    06 Dec 2021
    update Protokol Version 1.4 ,dated 24/09/2021 and PICF , dated 24/09/2021; Changes according to SmPC - SimvaHEXAL Information from May 2020

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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