ID

28900

Beschreibung

Cognitive-Behavioral Therapy (CBT) in Women Discontinuing Antidepressant for Pregnancy; ODM derived from: https://clinicaltrials.gov/show/NCT01453114

Link

https://clinicaltrials.gov/show/NCT01453114

Stichworte

Versionen (1)
  1. 13.02.18 13.02.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

13. Februar 2018

DOI

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Eligibility Depression NCT01453114

Englisch

Eligibility Depression NCT01453114

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT01453114
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects will include women 18 years and older who are either planning pregnancy or already pregnant and meet the following criteria:
Beschreibung

Gender | Age | Pregnancy, Planned | Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0032992
UMLS CUI [4]
C0032961
currently meet criteria for stable remission from depression (defined as a baseline score of ≤ 9 on the hamilton rating scale for depression (hrsd) and documented clinical remission for a minimum of six months prior to randomization)
Beschreibung

Depressive disorder Remission Stable Hamilton rating scale for depression

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011581
UMLS CUI [1,2]
C0544452
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0451203
current or recent treatment with an antidepressant (stable dosage for at least the last four weeks)
Beschreibung

Antidepressive Agents Dosage Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0677946
have a history of a major depressive episode
Beschreibung

Major depressive episode

Datentyp

boolean

Alias
UMLS CUI [1]
C0024517
decide to discontinue antidepressant medication for pregnancy
Beschreibung

Antidepressive Agents Pregnancy | Decision Antidepressive Agents Discontinue

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0032961
UMLS CUI [2,1]
C0679006
UMLS CUI [2,2]
C0003289
UMLS CUI [2,3]
C1444662
currently receive ongoing psychiatric care provided by a physician outside the mgh center for women's mental health, and written, informed consent.
Beschreibung

Psychiatric patient care | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0597312
UMLS CUI [2]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
significant risk for self-harm or harm to others
Beschreibung

At risk for self harm | Risk of harm to others

Datentyp

boolean

Alias
UMLS CUI [1]
C1276053
UMLS CUI [2]
C0549013
psychotic symptoms
Beschreibung

Psychotic symptom

Datentyp

boolean

Alias
UMLS CUI [1]
C0871189
meeting criteria for a primary scid-i/p diagnosis of schizophrenia, bipolar disorder, an active eating disorder, dementia, delirium, or other cognitive disorder
Beschreibung

Schizophrenia | Bipolar Disorder | Eating Disorders | Dementia | Delirium | Cognition Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0005586
UMLS CUI [3]
C0013473
UMLS CUI [4]
C0497327
UMLS CUI [5]
C0011206
UMLS CUI [6]
C0009241
presence of an active substance and/or alcohol abuse disorder within six months prior to screening visit
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
current use of mood stabilizers, antipsychotics or antiepileptics
Beschreibung

Mood Stabilizer | Antipsychotic Agents | Antiepileptic Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C2917435
UMLS CUI [2]
C0040615
UMLS CUI [3]
C0003299
have received cognitive-behavioral or interpersonal therapy within the last year
Beschreibung

Cognitive Therapy | Interpersonal intervention

Datentyp

boolean

Alias
UMLS CUI [1]
C0009244
UMLS CUI [2]
C0204548
diagnosed with a medical disorder that has a known association with depressive symptoms (e. g. thyroid disorder).
Beschreibung

Disease Associated with Depressive Symptoms | Thyroid Diseases

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0086132
UMLS CUI [2]
C0040128
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Ähnliche Modelle

Eligibility Depression NCT01453114

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT01453114
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age | Pregnancy, Planned | Pregnancy
Item
subjects will include women 18 years and older who are either planning pregnancy or already pregnant and meet the following criteria:
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0032961 (UMLS CUI [4])
Depressive disorder Remission Stable Hamilton rating scale for depression
Item
currently meet criteria for stable remission from depression (defined as a baseline score of ≤ 9 on the hamilton rating scale for depression (hrsd) and documented clinical remission for a minimum of six months prior to randomization)
boolean
C0011581 (UMLS CUI [1,1])
C0544452 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0451203 (UMLS CUI [1,4])
Antidepressive Agents Dosage Stable
Item
current or recent treatment with an antidepressant (stable dosage for at least the last four weeks)
boolean
C0003289 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0677946 (UMLS CUI [1,3])
Major depressive episode
Item
have a history of a major depressive episode
boolean
C0024517 (UMLS CUI [1])
Antidepressive Agents Pregnancy | Decision Antidepressive Agents Discontinue
Item
decide to discontinue antidepressant medication for pregnancy
boolean
C0003289 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0679006 (UMLS CUI [2,1])
C0003289 (UMLS CUI [2,2])
C1444662 (UMLS CUI [2,3])
Psychiatric patient care | Informed Consent
Item
currently receive ongoing psychiatric care provided by a physician outside the mgh center for women's mental health, and written, informed consent.
boolean
C0597312 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
At risk for self harm | Risk of harm to others
Item
significant risk for self-harm or harm to others
boolean
C1276053 (UMLS CUI [1])
C0549013 (UMLS CUI [2])
Psychotic symptom
Item
psychotic symptoms
boolean
C0871189 (UMLS CUI [1])
Schizophrenia | Bipolar Disorder | Eating Disorders | Dementia | Delirium | Cognition Disorders
Item
meeting criteria for a primary scid-i/p diagnosis of schizophrenia, bipolar disorder, an active eating disorder, dementia, delirium, or other cognitive disorder
boolean
C0036341 (UMLS CUI [1])
C0005586 (UMLS CUI [2])
C0013473 (UMLS CUI [3])
C0497327 (UMLS CUI [4])
C0011206 (UMLS CUI [5])
C0009241 (UMLS CUI [6])
Substance Use Disorders
Item
presence of an active substance and/or alcohol abuse disorder within six months prior to screening visit
boolean
C0038586 (UMLS CUI [1])
Mood Stabilizer | Antipsychotic Agents | Antiepileptic Agents
Item
current use of mood stabilizers, antipsychotics or antiepileptics
boolean
C2917435 (UMLS CUI [1])
C0040615 (UMLS CUI [2])
C0003299 (UMLS CUI [3])
Cognitive Therapy | Interpersonal intervention
Item
have received cognitive-behavioral or interpersonal therapy within the last year
boolean
C0009244 (UMLS CUI [1])
C0204548 (UMLS CUI [2])
Disease Associated with Depressive Symptoms | Thyroid Diseases
Item
diagnosed with a medical disorder that has a known association with depressive symptoms (e. g. thyroid disorder).
boolean
C0012634 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0086132 (UMLS CUI [1,3])
C0040128 (UMLS CUI [2])
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