ID

44800

Beskrivning

A single center, open label study assessing the feasibility, safety and therapeutic effect of Minocycline in adult patients with diagnosis of unipolar depression. Eligibility

Nyckelord

Versioner (1)
  1. 2021-12-01 2021-12-01 - Tabea Kampen
Rättsinnehavare

Shalvata Mental Health Center

Uppladdad den

1 december 2021

DOI

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Licens

Creative Commons BY 4.0
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Open Study Assessing the Feasibility of Minocycline in Patients With Unipolar Depression NCT01574742

Tysk Engelsk

Eligibility Unipolar Depression NCT01574742

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Unipolar Depression NCT01574742
  2. StudyEvent: Outcome Measures
  3. StudyEvent: Arms and Interventions
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
Inpatient or Outpatient
Beskrivning

Admission type

Datatyp

boolean

Alias
UMLS CUI [1]
C1550330
Age at least 18 years and not older than 68 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
SNOMED CT 2011_0131
397669002
Primary DSM-IV diagnosis of Depression, single or recurrent episode confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV), with the additional requirements of a current episode ≥4 weeks and CGI-S ≥4.
Beskrivning

Diagnosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011581
UMLS CUI [1,2]
C0521116
UMLS CUI [1,3]
C3639708
Total hdrs-21 ≥20 and item 1 score ≥2 at the screening visit.
Beskrivning

Depression scale

Datatyp

boolean

Alias
UMLS CUI [1]
C2021166
The patient did not respond to at least one antidepressant medication given for an accepted dose and duration.
Beskrivning

Response to antidepressant medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3844724
UMLS CUI [1,2]
C0003289
Capable and willing to provide informed consent
Beskrivning

Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Able to adhere to the treatment schedule.
Beskrivning

Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
Depression secondary to a general medical condition.
Beskrivning

Secondary depression

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0277555
UMLS CUI [1,2]
C0011581
History of substance abuse or dependence within the past 6 month (except opioids, nicotine and caffeine).
Beskrivning

Substance abuse/ dependence

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
All antidepressant medications, must have been in stable dosage for at least 3 weeks prior to entry into the study, with no anticipation of change over the duration of the study.
Beskrivning

Antidepressant medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0205360
Use of any medication(s) listed on the excluded medication list within the time that mention for each medication on the list.
Beskrivning

Medication

Datatyp

boolean

Alias
UMLS CUI [1]
C0013227
Any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features • bipolar disorder • eating disorder
Beskrivning

Psychotic, affective and behavioral disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0033975
UMLS CUI [2]
C0005586
UMLS CUI [3]
C0013473
Subjects who were taking a known contraindication to minocycline treatment.
Beskrivning

Contraindication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0026187
Subjects who had received treatment with minocycline or β-lactam antibiotics in the preceding half year before study entry.
Beskrivning

Pretreatment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026187
UMLS CUI [1,2]
C0003232
Present suicidal risk as assessed by the investigator or significant suicide risk based on hdrs-21 item 3 score of 3 or 4 or a history of attempted suicide in the last 6 month
Beskrivning

Suicidal risk

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C0038663
Known or suspected pregnancy or women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse (if using oral contraceptives, during the minocycline treatment, subject should use an additional contraceptives), or women who are breastfeeding
Beskrivning

Pregnancy and breastfeeding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2919192
UMLS CUI [1,2]
C0032961
UMLS CUI [1,3]
C0006147
Patients with severe hepatic or renal insufficiency.
Beskrivning

Hepatic or renal insufficiency

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1306571
UMLS CUI [1,2]
C1565489
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Similar models

Eligibility Unipolar Depression NCT01574742

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Unipolar Depression NCT01574742
  2. StudyEvent: Outcome Measures
  3. StudyEvent: Arms and Interventions
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Admission type
Item
Inpatient or Outpatient
boolean
C1550330 (UMLS CUI [1])
Age
Item
Age at least 18 years and not older than 68 years
boolean
C0001779 (UMLS CUI [1])
397669002 (SNOMED CT 2011_0131)
Diagnosis
Item
Primary DSM-IV diagnosis of Depression, single or recurrent episode confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV), with the additional requirements of a current episode ≥4 weeks and CGI-S ≥4.
boolean
C0011581 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C3639708 (UMLS CUI [1,3])
Depression scale
Item
Total hdrs-21 ≥20 and item 1 score ≥2 at the screening visit.
boolean
C2021166 (UMLS CUI [1])
()
Response to antidepressant medication
Item
The patient did not respond to at least one antidepressant medication given for an accepted dose and duration.
boolean
C3844724 (UMLS CUI [1,1])
C0003289 (UMLS CUI [1,2])
Consent
Item
Capable and willing to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Compliance
Item
Able to adhere to the treatment schedule.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Secondary depression
Item
Depression secondary to a general medical condition.
boolean
C0277555 (UMLS CUI [1,1])
C0011581 (UMLS CUI [1,2])
Substance abuse/ dependence
Item
History of substance abuse or dependence within the past 6 month (except opioids, nicotine and caffeine).
boolean
C0038586 (UMLS CUI [1])
Antidepressant medication
Item
All antidepressant medications, must have been in stable dosage for at least 3 weeks prior to entry into the study, with no anticipation of change over the duration of the study.
boolean
C0003289 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Medication
Item
Use of any medication(s) listed on the excluded medication list within the time that mention for each medication on the list.
boolean
C0013227 (UMLS CUI [1])
Psychotic, affective and behavioral disorders
Item
Any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features • bipolar disorder • eating disorder
boolean
C0033975 (UMLS CUI [1])
C0005586 (UMLS CUI [2])
C0013473 (UMLS CUI [3])
Contraindication
Item
Subjects who were taking a known contraindication to minocycline treatment.
boolean
C1301624 (UMLS CUI [1,1])
C0026187 (UMLS CUI [1,2])
Pretreatment
Item
Subjects who had received treatment with minocycline or β-lactam antibiotics in the preceding half year before study entry.
boolean
C0026187 (UMLS CUI [1,1])
C0003232 (UMLS CUI [1,2])
Suicidal risk
Item
Present suicidal risk as assessed by the investigator or significant suicide risk based on hdrs-21 item 3 score of 3 or 4 or a history of attempted suicide in the last 6 month
boolean
C0563664 (UMLS CUI [1,1])
C0038663 (UMLS CUI [1,2])
Pregnancy and breastfeeding
Item
Known or suspected pregnancy or women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse (if using oral contraceptives, during the minocycline treatment, subject should use an additional contraceptives), or women who are breastfeeding
boolean
C2919192 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0006147 (UMLS CUI [1,3])
Hepatic or renal insufficiency
Item
Patients with severe hepatic or renal insufficiency.
boolean
C1306571 (UMLS CUI [1,1])
C1565489 (UMLS CUI [1,2])
Tillbaka till toppen 

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