ID

12947

Description

Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers; ODM derived from: https://clinicaltrials.gov/show/NCT00018174

Link

https://clinicaltrials.gov/show/NCT00018174

Keywords

Versions (1)
  1. 1/7/16 1/7/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 7, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Depression NCT00018174

English

Eligibility Depression NCT00018174

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00018174
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects will be 144 smokers who have experienced at least one episode of major depressive disorder and 206 smokers who lack a lifetime history of major depressive disorder.
Description

subjects will be 144 smokers who have experienced at least one episode of major depressive disorder and 206 smokers who lack a lifetime history of major depressive disorder.

Data type

boolean

Alias
UMLS CUI [1]
C0543414
UMLS CUI [2]
C1269683
none will currently meet diagnostic criteria for major depression, nor will they have met criteria in the past 6 months.
Description

none will currently meet diagnostic criteria for major depression, nor will they have met criteria in the past 6 months.

Data type

boolean

Alias
UMLS CUI [1]
C1269683
all will be male and female community members between the ages of 18 and 65 who have smoker at least 10 cigarettes a day for the past year.
Description

all will be male and female community members between the ages of 18 and 65 who have smoker at least 10 cigarettes a day for the past year.

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0543414
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. have taken monoamine oxidase inhibitors, antidepressants, anti-anxiety agents, lithium, tryptophan or phenothiazines within the past month;
Description

1. have taken monoamine oxidase inhibitors, antidepressants, anti-anxiety agents, lithium, tryptophan or phenothiazines within the past month;

Data type

boolean

Alias
UMLS CUI [1]
C0026457
UMLS CUI [2]
C0003289
UMLS CUI [3]
C0040616
UMLS CUI [4]
C0023870
UMLS CUI [5]
C0041249
UMLS CUI [6]
C0031436
2. are being treated for hypertension with guanethidine, reserpine, thiazide diuretics, beta blockers, or clonidine;
Description

2. are being treated for hypertension with guanethidine, reserpine, thiazide diuretics, beta blockers, or clonidine;

Data type

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0018318
UMLS CUI [3]
C0035179
UMLS CUI [4]
C0541746
UMLS CUI [5]
C0304516
UMLS CUI [6]
C0009014
3. are taking type ic antiarrhythmics (e.g., propafenone and flecanide) or a highly protein-bound drug (e.g., warfarin, digitoxin);
Description

3. are taking type ic antiarrhythmics (e.g., propafenone and flecanide) or a highly protein-bound drug (e.g., warfarin, digitoxin);

Data type

boolean

Alias
UMLS CUI [1]
C0003195
UMLS CUI [2]
C0043031
UMLS CUI [3]
C0012258
4. have a medically unstable condition or had a major health event in the past 6 months (e.g., myocardial infarct or major surgery);
Description

4. have a medically unstable condition or had a major health event in the past 6 months (e.g., myocardial infarct or major surgery);

Data type

boolean

Alias
UMLS CUI [1]
C0009488
5. have cbc values more than 10% outside the normal limits, or liver enzymes exceeding 40% of the upper limit of normal;
Description

5. have cbc values more than 10% outside the normal limits, or liver enzymes exceeding 40% of the upper limit of normal;

Data type

boolean

Alias
UMLS CUI [1]
C0009555
UMLS CUI [2]
C1287351
6. have a history of severe allergies, multiple adverse drug reactions or known allergy to fluoxetine;
Description

6. have a history of severe allergies, multiple adverse drug reactions or known allergy to fluoxetine;

Data type

boolean

Alias
UMLS CUI [1]
C0020517
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0016365
7. are actively abusing alcohol or drugs or received inpatient treatment for substance abuse within the past year;
Description

7. are actively abusing alcohol or drugs or received inpatient treatment for substance abuse within the past year;

Data type

boolean

Alias
UMLS CUI [1]
C0038586
8. are using nicotine replacements;
Description

8. are using nicotine replacements;

Data type

boolean

Alias
UMLS CUI [1]
C1278444
9. are pregnant, lactating, or of childbearing potential;
Description

9. are pregnant, lactating, or of childbearing potential;

Data type

boolean

Alias
UMLS CUI [1]
C0032961
10. present current evidence of organic brain disease, definite or subclinical major depressive disorder or serious suicidal risk post-traumatic stress disorder, or premenstrual dysphoric disorder;
Description

10. present current evidence of organic brain disease, definite or subclinical major depressive disorder or serious suicidal risk post-traumatic stress disorder, or premenstrual dysphoric disorder;

Data type

boolean

Alias
UMLS CUI [1]
C0009488
11. have a score greater than 14 on the 21-item hamilton depression rating scale or greater than 15 on the beck depression inventory;
Description

11. have a score greater than 14 on the 21-item hamilton depression rating scale or greater than 15 on the beck depression inventory;

Data type

boolean

Alias
UMLS CUI [1]
C0451203
UMLS CUI [2]
C0451022
12. have a history of seizures, mania or hypomania, or psychosis. individuals with bipolar disorder, ptsd, or schizophrenia will be excluded because they might respond adversely to fluoxetine.
Description

12. have a history of seizures, mania or hypomania, or psychosis. individuals with bipolar disorder, ptsd, or schizophrenia will be excluded because they might respond adversely to fluoxetine.

Data type

boolean

Alias
UMLS CUI [1]
C0009488
subjects with dysthymic disorder or anxiety disorders will be studied if their current symptoms are not sequelae of an episode of major depression. excluding such cases would purify the sample by removing mild degrees of dysphoria, but would greatly restrict our ability to generalize any treatment implications to the current population that smokers.
Description

subjects with dysthymic disorder or anxiety disorders will be studied if their current symptoms are not sequelae of an episode of major depression. excluding such cases would purify the sample by removing mild degrees of dysphoria, but would greatly restrict our ability to generalize any treatment implications to the current population that smokers.

Data type

boolean

Alias
UMLS CUI [1]
C0009488
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Similar models

Eligibility Depression NCT00018174

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00018174
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
subjects will be 144 smokers who have experienced at least one episode of major depressive disorder and 206 smokers who lack a lifetime history of major depressive disorder.
Item
subjects will be 144 smokers who have experienced at least one episode of major depressive disorder and 206 smokers who lack a lifetime history of major depressive disorder.
boolean
C0543414 (UMLS CUI [1])
C1269683 (UMLS CUI [2])
none will currently meet diagnostic criteria for major depression, nor will they have met criteria in the past 6 months.
Item
none will currently meet diagnostic criteria for major depression, nor will they have met criteria in the past 6 months.
boolean
C1269683 (UMLS CUI [1])
all will be male and female community members between the ages of 18 and 65 who have smoker at least 10 cigarettes a day for the past year.
Item
all will be male and female community members between the ages of 18 and 65 who have smoker at least 10 cigarettes a day for the past year.
boolean
C0001779 (UMLS CUI [1])
C0543414 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
1. have taken monoamine oxidase inhibitors, antidepressants, anti-anxiety agents, lithium, tryptophan or phenothiazines within the past month;
Item
1. have taken monoamine oxidase inhibitors, antidepressants, anti-anxiety agents, lithium, tryptophan or phenothiazines within the past month;
boolean
C0026457 (UMLS CUI [1])
C0003289 (UMLS CUI [2])
C0040616 (UMLS CUI [3])
C0023870 (UMLS CUI [4])
C0041249 (UMLS CUI [5])
C0031436 (UMLS CUI [6])
2. are being treated for hypertension with guanethidine, reserpine, thiazide diuretics, beta blockers, or clonidine;
Item
2. are being treated for hypertension with guanethidine, reserpine, thiazide diuretics, beta blockers, or clonidine;
boolean
C0020538 (UMLS CUI [1])
C0018318 (UMLS CUI [2])
C0035179 (UMLS CUI [3])
C0541746 (UMLS CUI [4])
C0304516 (UMLS CUI [5])
C0009014 (UMLS CUI [6])
3. are taking type ic antiarrhythmics (e.g., propafenone and flecanide) or a highly protein-bound drug (e.g., warfarin, digitoxin);
Item
3. are taking type ic antiarrhythmics (e.g., propafenone and flecanide) or a highly protein-bound drug (e.g., warfarin, digitoxin);
boolean
C0003195 (UMLS CUI [1])
C0043031 (UMLS CUI [2])
C0012258 (UMLS CUI [3])
4. have a medically unstable condition or had a major health event in the past 6 months (e.g., myocardial infarct or major surgery);
Item
4. have a medically unstable condition or had a major health event in the past 6 months (e.g., myocardial infarct or major surgery);
boolean
C0009488 (UMLS CUI [1])
5. have cbc values more than 10% outside the normal limits, or liver enzymes exceeding 40% of the upper limit of normal;
Item
5. have cbc values more than 10% outside the normal limits, or liver enzymes exceeding 40% of the upper limit of normal;
boolean
C0009555 (UMLS CUI [1])
C1287351 (UMLS CUI [2])
6. have a history of severe allergies, multiple adverse drug reactions or known allergy to fluoxetine;
Item
6. have a history of severe allergies, multiple adverse drug reactions or known allergy to fluoxetine;
boolean
C0020517 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0016365 (UMLS CUI [2,2])
7. are actively abusing alcohol or drugs or received inpatient treatment for substance abuse within the past year;
Item
7. are actively abusing alcohol or drugs or received inpatient treatment for substance abuse within the past year;
boolean
C0038586 (UMLS CUI [1])
8. are using nicotine replacements;
Item
8. are using nicotine replacements;
boolean
C1278444 (UMLS CUI [1])
9. are pregnant, lactating, or of childbearing potential;
Item
9. are pregnant, lactating, or of childbearing potential;
boolean
C0032961 (UMLS CUI [1])
10. present current evidence of organic brain disease, definite or subclinical major depressive disorder or serious suicidal risk post-traumatic stress disorder, or premenstrual dysphoric disorder;
Item
10. present current evidence of organic brain disease, definite or subclinical major depressive disorder or serious suicidal risk post-traumatic stress disorder, or premenstrual dysphoric disorder;
boolean
C0009488 (UMLS CUI [1])
11. have a score greater than 14 on the 21-item hamilton depression rating scale or greater than 15 on the beck depression inventory;
Item
11. have a score greater than 14 on the 21-item hamilton depression rating scale or greater than 15 on the beck depression inventory;
boolean
C0451203 (UMLS CUI [1])
C0451022 (UMLS CUI [2])
12. have a history of seizures, mania or hypomania, or psychosis. individuals with bipolar disorder, ptsd, or schizophrenia will be excluded because they might respond adversely to fluoxetine.
Item
12. have a history of seizures, mania or hypomania, or psychosis. individuals with bipolar disorder, ptsd, or schizophrenia will be excluded because they might respond adversely to fluoxetine.
boolean
C0009488 (UMLS CUI [1])
subjects with dysthymic disorder or anxiety disorders will be studied if their current symptoms are not sequelae of an episode of major depression. excluding such cases would purify the sample by removing mild degrees of dysphoria, but would greatly restrict our ability to generalize any treatment implications to the current population that smokers.
Item
subjects with dysthymic disorder or anxiety disorders will be studied if their current symptoms are not sequelae of an episode of major depression. excluding such cases would purify the sample by removing mild degrees of dysphoria, but would greatly restrict our ability to generalize any treatment implications to the current population that smokers.
boolean
C0009488 (UMLS CUI [1])
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