ID

25291

Beskrivning

A Double Blind Sham Controlled Trial of tDCS in Treating Schizophrenia and Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00481026

Länk

https://clinicaltrials.gov/show/NCT00481026

Nyckelord

Versioner (1)
  1. 8/31/17 8/31/17 -
Uppladdad den

August 31, 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00481026

Engelsk

Eligibility Schizophrenia NCT00481026

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
schizophrenia
Beskrivning

Schizophrenia

Datatyp

boolean

Alias
UMLS CUI [1]
C0036341
participants will be included if they:
Beskrivning

Study Subject Participation Status Inclusion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1512693
1. are voluntary and competent to consent;
Beskrivning

Voluntary participation | Competence Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0680274
UMLS CUI [2,1]
C0086035
UMLS CUI [2,2]
C1511481
2. have a diagnosis of schizophrenia or schizoaffective disorder as confirmed by the structure clinical interview for the dsm-iv (scid-iv)
Beskrivning

Schizophrenia | Schizoaffective Disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036337
3. have persistent positive and negative symptoms despite having trialled, or being currently medicated, with antipsychotic medication; and
Beskrivning

Positive and negative symptoms persistent | Drug trial | Antipsychotic Agents

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0871099
UMLS CUI [1,2]
C0205322
UMLS CUI [2]
C0304229
UMLS CUI [3]
C0040615
4. are between the ages of 18 and 65.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
concomitant medications including:
Beskrivning

Pharmaceutical Preparations

Datatyp

boolean

Alias
UMLS CUI [1]
C0013227
1. benzodiazepines,
Beskrivning

Benzodiazepines

Datatyp

boolean

Alias
UMLS CUI [1]
C0005064
2. mood stabilizers (lithium, valproic acid)
Beskrivning

Mood Stabilizers | Lithium | Valproic Acid

Datatyp

boolean

Alias
UMLS CUI [1]
C4020582
UMLS CUI [2]
C0023870
UMLS CUI [3]
C0042291
3. antidepressants (including serotonin reuptake inhibitors and tricyclic antidepressants) and anticholinergics will be allowed. since carbamazepine has been shown to interfere with the effects of anodal tdcs, potential participants taking it will not be suitable for inclusion in the trial.
Beskrivning

Antidepressive Agents | Serotonin Uptake Inhibitors | Tricyclic Antidepressive Agents | Anticholinergic Agents | Carbamazepine Interferes with Anodal Transcranial Direct Current Stimulation Effects

Datatyp

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2]
C0162758
UMLS CUI [3]
C0003290
UMLS CUI [4]
C0242896
UMLS CUI [5,1]
C0006949
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C3850022
UMLS CUI [5,4]
C1280500
depression
Beskrivning

Depressive disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0011581
participants will be included if they:
Beskrivning

Study Subject Participation Status Inclusion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1512693
1. are competent to consent;
Beskrivning

Competence Consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0086035
UMLS CUI [1,2]
C1511481
2. have a diagnosis of major depression and are currently experiencing a major depressive episode as confirmed by the structure clinical interview for the dsm-iv (scid-iv);
Beskrivning

Major Depressive Disorder | Major depressive episode

Datatyp

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2]
C0024517
3. are treatment resistant, defined as a failure to achieve a clinical response, or an inability to tolerate, an antidepressant trial of sufficient dose for at least 6 weeks; and
Beskrivning

Treatment Resistant Disorders | Absent response to treatment | Intolerance to Antidepressive Agents Dose

Datatyp

boolean

Alias
UMLS CUI [1]
C0871547
UMLS CUI [2]
C0438286
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0003289
UMLS CUI [3,3]
C0178602
4. are between the ages of 18 and 75.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
concomitant medications including:
Beskrivning

Pharmaceutical Preparations

Datatyp

boolean

Alias
UMLS CUI [1]
C0013227
1. benzodiazepines,
Beskrivning

Benzodiazepines

Datatyp

boolean

Alias
UMLS CUI [1]
C0005064
2. mood stabilizers (lithium, valproic acid)
Beskrivning

Mood Stabilizers | Lithium | Valproic Acid

Datatyp

boolean

Alias
UMLS CUI [1]
C4020582
UMLS CUI [2]
C0023870
UMLS CUI [3]
C0042291
3. antidepressants (including serotonin reuptake inhibitors and tricyclic antidepressants) and anticholinergics will be allowed. since carbamazepine has been shown to interfere with the effects of anodal tdcs, potential participants taking it will not be suitable for inclusion in the trial.
Beskrivning

Antidepressive Agents | Serotonin Uptake Inhibitors | Tricyclic Antidepressive Agents | Anticholinergic Agents | Carbamazepine Interferes with Anodal Transcranial Direct Current Stimulation Effects

Datatyp

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2]
C0162758
UMLS CUI [3]
C0003290
UMLS CUI [4]
C0242896
UMLS CUI [5,1]
C0006949
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C3850022
UMLS CUI [5,4]
C1280500
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients will be excluded if they:
Beskrivning

Study Subject Participation Status Exclusion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C2828389
1. have a dsm-iv history of substance abuse or dependence in the last 6 months;
Beskrivning

Substance Use Disorders | Substance Dependence

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
2. have a concomitant major and unstable medical or neurologic illness;
Beskrivning

Comorbidity Major Unstable | Nervous system disorder Major Unstable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0443343
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0205164
UMLS CUI [2,3]
C0443343
3. are currently taking carbamazepine; or,
Beskrivning

Carbamazepine

Datatyp

boolean

Alias
UMLS CUI [1]
C0006949
4. are pregnant.
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
patients will be withdrawn from the study if they:
Beskrivning

Patient withdrawn from trial

Datatyp

boolean

Alias
UMLS CUI [1]
C0422727
1. withdraw consent;
Beskrivning

Consent Withdraw

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1511481
UMLS CUI [1,2]
C2349954
2. experience significant clinical deterioration;
Beskrivning

Deterioration Clinical Significance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1279889
UMLS CUI [1,2]
C2826293
3. fail to tolerate the procedure; or,
Beskrivning

Therapeutic procedure Receive failed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C0231175
4. develop a serious adverse event. in the event that a patient is withdrawn or drops out of the study, efforts will be made to obtain a final set of clinical, cognitive and neurophysiological measures at the time of withdrawal for a last observation carried forward analysis.
Beskrivning

Adverse event Serious | Patient withdrawn from trial | Withdrawal by Subject | Interventional procedure Clinical | Interventional procedure Cognitive | Interventional procedure Neurophysiology

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0422727
UMLS CUI [3]
C1710677
UMLS CUI [4,1]
C0184661
UMLS CUI [4,2]
C0205210
UMLS CUI [5,1]
C0184661
UMLS CUI [5,2]
C1516691
UMLS CUI [6,1]
C0184661
UMLS CUI [6,2]
C0700630
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Similar models

Eligibility Schizophrenia NCT00481026

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia
Item
schizophrenia
boolean
C0036341 (UMLS CUI [1])
Study Subject Participation Status Inclusion
Item
participants will be included if they:
boolean
C2348568 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
Voluntary participation | Competence Consent
Item
1. are voluntary and competent to consent;
boolean
C0680274 (UMLS CUI [1])
C0086035 (UMLS CUI [2,1])
C1511481 (UMLS CUI [2,2])
Schizophrenia | Schizoaffective Disorder
Item
2. have a diagnosis of schizophrenia or schizoaffective disorder as confirmed by the structure clinical interview for the dsm-iv (scid-iv)
boolean
C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
Positive and negative symptoms persistent | Drug trial | Antipsychotic Agents
Item
3. have persistent positive and negative symptoms despite having trialled, or being currently medicated, with antipsychotic medication; and
boolean
C0871099 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2])
C0040615 (UMLS CUI [3])
Age
Item
4. are between the ages of 18 and 65.
boolean
C0001779 (UMLS CUI [1])
Pharmaceutical Preparations
Item
concomitant medications including:
boolean
C0013227 (UMLS CUI [1])
Benzodiazepines
Item
1. benzodiazepines,
boolean
C0005064 (UMLS CUI [1])
Mood Stabilizers | Lithium | Valproic Acid
Item
2. mood stabilizers (lithium, valproic acid)
boolean
C4020582 (UMLS CUI [1])
C0023870 (UMLS CUI [2])
C0042291 (UMLS CUI [3])
Antidepressive Agents | Serotonin Uptake Inhibitors | Tricyclic Antidepressive Agents | Anticholinergic Agents | Carbamazepine Interferes with Anodal Transcranial Direct Current Stimulation Effects
Item
3. antidepressants (including serotonin reuptake inhibitors and tricyclic antidepressants) and anticholinergics will be allowed. since carbamazepine has been shown to interfere with the effects of anodal tdcs, potential participants taking it will not be suitable for inclusion in the trial.
boolean
C0003289 (UMLS CUI [1])
C0162758 (UMLS CUI [2])
C0003290 (UMLS CUI [3])
C0242896 (UMLS CUI [4])
C0006949 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C3850022 (UMLS CUI [5,3])
C1280500 (UMLS CUI [5,4])
Depressive disorder
Item
depression
boolean
C0011581 (UMLS CUI [1])
Study Subject Participation Status Inclusion
Item
participants will be included if they:
boolean
C2348568 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
Competence Consent
Item
1. are competent to consent;
boolean
C0086035 (UMLS CUI [1,1])
C1511481 (UMLS CUI [1,2])
Major Depressive Disorder | Major depressive episode
Item
2. have a diagnosis of major depression and are currently experiencing a major depressive episode as confirmed by the structure clinical interview for the dsm-iv (scid-iv);
boolean
C1269683 (UMLS CUI [1])
C0024517 (UMLS CUI [2])
Treatment Resistant Disorders | Absent response to treatment | Intolerance to Antidepressive Agents Dose
Item
3. are treatment resistant, defined as a failure to achieve a clinical response, or an inability to tolerate, an antidepressant trial of sufficient dose for at least 6 weeks; and
boolean
C0871547 (UMLS CUI [1])
C0438286 (UMLS CUI [2])
C1744706 (UMLS CUI [3,1])
C0003289 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
Age
Item
4. are between the ages of 18 and 75.
boolean
C0001779 (UMLS CUI [1])
Pharmaceutical Preparations
Item
concomitant medications including:
boolean
C0013227 (UMLS CUI [1])
Benzodiazepines
Item
1. benzodiazepines,
boolean
C0005064 (UMLS CUI [1])
Mood Stabilizers | Lithium | Valproic Acid
Item
2. mood stabilizers (lithium, valproic acid)
boolean
C4020582 (UMLS CUI [1])
C0023870 (UMLS CUI [2])
C0042291 (UMLS CUI [3])
Antidepressive Agents | Serotonin Uptake Inhibitors | Tricyclic Antidepressive Agents | Anticholinergic Agents | Carbamazepine Interferes with Anodal Transcranial Direct Current Stimulation Effects
Item
3. antidepressants (including serotonin reuptake inhibitors and tricyclic antidepressants) and anticholinergics will be allowed. since carbamazepine has been shown to interfere with the effects of anodal tdcs, potential participants taking it will not be suitable for inclusion in the trial.
boolean
C0003289 (UMLS CUI [1])
C0162758 (UMLS CUI [2])
C0003290 (UMLS CUI [3])
C0242896 (UMLS CUI [4])
C0006949 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C3850022 (UMLS CUI [5,3])
C1280500 (UMLS CUI [5,4])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status Exclusion
Item
patients will be excluded if they:
boolean
C2348568 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Substance Use Disorders | Substance Dependence
Item
1. have a dsm-iv history of substance abuse or dependence in the last 6 months;
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Comorbidity Major Unstable | Nervous system disorder Major Unstable
Item
2. have a concomitant major and unstable medical or neurologic illness;
boolean
C0009488 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
C0027765 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0443343 (UMLS CUI [2,3])
Carbamazepine
Item
3. are currently taking carbamazepine; or,
boolean
C0006949 (UMLS CUI [1])
Pregnancy
Item
4. are pregnant.
boolean
C0032961 (UMLS CUI [1])
Patient withdrawn from trial
Item
patients will be withdrawn from the study if they:
boolean
C0422727 (UMLS CUI [1])
Consent Withdraw
Item
1. withdraw consent;
boolean
C1511481 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Deterioration Clinical Significance
Item
2. experience significant clinical deterioration;
boolean
C1279889 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Therapeutic procedure Receive failed
Item
3. fail to tolerate the procedure; or,
boolean
C0087111 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Adverse event Serious | Patient withdrawn from trial | Withdrawal by Subject | Interventional procedure Clinical | Interventional procedure Cognitive | Interventional procedure Neurophysiology
Item
4. develop a serious adverse event. in the event that a patient is withdrawn or drops out of the study, efforts will be made to obtain a final set of clinical, cognitive and neurophysiological measures at the time of withdrawal for a last observation carried forward analysis.
boolean
C0877248 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0422727 (UMLS CUI [2])
C1710677 (UMLS CUI [3])
C0184661 (UMLS CUI [4,1])
C0205210 (UMLS CUI [4,2])
C0184661 (UMLS CUI [5,1])
C1516691 (UMLS CUI [5,2])
C0184661 (UMLS CUI [6,1])
C0700630 (UMLS CUI [6,2])
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