Minocycline, a broad-spectrum and central nervous system entering tetracycline, reduces within an additional therapy the symptomatology of depressive patients.
Conditions
Interventions
Trade Name: Udima
Product Name: Minocycline
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Minocycline Hydrochloride dihydrate
CAS Number: 10118-90-8
Current Sponsor code: Minocycline Hydroch
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subject information sheets and written informed consent • Age 18-75 • BMI 18- inclusive 40 • negative pregnancy test • safe contraxeptive method (peral index =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: • Presence of a neurodegenerative disease • Presence of a neurological disease, within which the depressive symptoms were associated to a depression • Presence of any severe, unstable somatic disease, including chronic inflammatory diseases such as rheumatoid arthritis or chronic inflammatory intestine diseases • The depressive symptoms can better be explained by possible comorbid psychiatric disorder, especially a personality disorder • Improvement by over 50% in the HAMD-17-score during the past 14 days • Pregnancy and breast feeding women • Substance or alcohol abuse during the past 6 months or a positive urinary drug Screening (Medication with benzodiazepinen is allowed as well as nicotine consumption) • Thyroid dysfunctions (if not substituted euthyroit), severe Malfunction of the liver or kidneys • Known autoimmune disease (lifetime prevalence) except euthyroid Hashimoto thyroiditis • Clinical relevant laboratory abnormalities • Current medication with ant-inflammatory substances (NSAID, Corticosteroids) • Current medication with Retinoids (Retinol, Retinoic acid or Retinoid-receptor agonists) • Any adverse event occurred in the past which was associated with an earlier intake of tetracyclines, including any hypersensitive reactions to tetracyclines and intolerance of tetracyclines • Any medication that is known to interact with Minocycline, in the case of requiring such medication, this will lead to break off the therapy with Minocycline • Current medication with barbiturates and other drugs with anticonvulsive effects (e.g. Carbamazepin, Diphenylhydantoin und Primidon) • Current medication with beta-lactam antibiotics, i.e. penicillines or cephalosporines • Current medication with isotretinoin or medication with isotretinoin during the past 4 weeks • Current medication with theophylline • Current medication with sulfonylurea antidiabetics and anticoagulants of the cumarine-type • Current medication with cyclosporine A • Current medication with Methotrexate • Being put under methoxyflurane anaesthetics or medication with other substances which could cause kidney damage • Lacking willingness to allow storage and transfer of pseudonymized medical data within the clinical Trial • Simultaneous administration of other psychtropic substances in addition to standard medication. For the therapy of severe agitation and anxiety as well as major sleeping disorder are only allowed Lorazepam (max. 4 mg/day) or Z-Hypnotics (Zolpidem (max. 10 mg/day), Zopicclone (max. 7.5 mg/day)) • Participation in a clinical trial according to the AMG during the past 8 weeks • Involuntary commitment in an institution by warrant of the court or agency • Acute suicidal tendency, suicide plan or attempt in the current disease episode or suicide attempt in the last 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Change in the MADRS value from starting point (week 1) to last visit (week 7), with weekly visits Time point of determination of primary target parameters (objective): week 1-6, 7, 6 week after and 6 months after last visit ;Secondary Objective: • Remission; remission is define as reduction of MADRS value is smaller than 9 • Response to therapy (response is define as reduction of MADRS value more than 50 % in comparison to week 1) • Evaluation of CGI-S, BDI, HAMD-17 and SCL-90R, TMT-A and B (determination time point CGI-S, BDI, HAMD-17: at the time of screening, during the conduct of the clinical trial in week 1 to 6 and last visit (week 7) as well as in 1FU and 2 FU ((6 Months after end of trial) (not BDI-S); TMT A and B, SCL 90R: at screening, during the study conduct in week 4 (only SCL 90R) and last visit (week 7) as well as in 1 FU (6 week after end of trial) • Measurement of the expression levels in peripheral blood mononuclear cell (PBMC) (week 1 and 7) and serum concentration of different Cytokine, cell-type specifically marker, neurotrophic as well as inflammatory processes and cell metabolism determination-factors in week 1, 4 (not PBMCs) and week 7 ;Primary end point(s): Primary end point is changes in the MADRS score from starting point (week 1) to (week 7);Timepoint(s) of evaluation of this end point: end of trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Remission; remission is define as reduction of MADRS value is smaller than 9 • Response to therapy (response is define as reduction of MADRS value more than 50 % in comparison to week 1) • Evaluation of CGI-S, BDI, HAMD-17 and SCL-90R, TMT-A and B (determination time point CGI-S, BDI, HAMD-17: at the time of screening, during the conduct of the clinical trial in week 1 to 6 and last visit (week 7) as well as in 1FU and 2 FU ((6 Months after end of trial) (not BDI-S)); TMT A and B, SCL 90R: at screening, during the study conduct in week 4 (only SCL 90R) and last visit (week 7) as well as in 1 FU (6 week after end of trial) Measurement of the expression levels in peripheral blood mononuclear cell (PBMC) (week 1 and 7) and serum concentration of different Cytokine, cell-type specifically marker, neurotrophic as well as inflammatory processes and cell metabolism determination-factors in week 1, 4 and week 7 • Genotype-determination therapy-Bestimmung therapie-affecting genetic variation (f.e. rs2032583, rs2235015, rs2235040, rs1045642, rs2032582, rs1128503 in the ABCB1-gene) (week 1);Timepoint(s) of evaluation of this end point: end of trial | — |
Countries
Germany
Contacts
Public ContactCharité - Campus Benjamin Franklin
Institut Klinik für Psychiatrie und Psychotherapie
Outcome results
None listed