ID

29022

Description

A Multi-Centre, Randomised, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Flexible Dose Study Evaluating the Efficacy, Safety and Tolerability of Extended-Release Bupropion Hydrochloride (150mg - 300mg once daily), Extended-Release Venlafaxine Hydrochloride (75mg - 150mg once daily) and Placebo in Subjects with Major Depressive Disorder

Keywords

Versions (1)
  1. 2/21/18 2/21/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 21, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Study Evaluating Extended-Release Bupropion Hydrochloride and Extended-Release Venlafaxine Hydrochloride in Subjects with Major Depressive Disorder [ID 101497]

English

Visit 1 (Screening): Eligibility Criteria

1 forms  
Screening Visit Inclusion Criteria
Description

Screening Visit Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Subject must have the ability to comprehend the key components of the consent form and must provide their written informed consent to participate in the study prior to any study-specific assessments or procedures.
Description

Informed constent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Subject must be an outpatient (male or female) and must be aged between 18 and 64 years (inclusive).
Description

outpatient | age

Data type

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
Subject has a diagnosis of Major Depressive Disorder, single episode or recurrent, DSM-IV (296.2/296.3) diagnosed with comprehensive psychiatric evaluation as assessed* by a physician with adequate training in psychiatry (e.g. Board Certification in US; Certificate of Completion of Specialist Training in EU).
Description

Physician assessment must include face-to-face evaluation of the subject, but may be aided by subject evaluation conducted by a healthcare professional with a clinically relevant qualification (e.g., psychiatric nurses or psychologists) and a minimum of two years documented experience assessing patients with Major Depressive Disorder.

Data type

boolean

Alias
UMLS CUI [1]
C0024517
UMLS CUI [2,1]
C1269683
UMLS CUI [2,2]
C0443287
In the Investigator's opinion, the subject must have met DSM-IV criteria for their current major depressive episode for at least 8 weeks
Description

DSM IV criteria for current major depressive episode

Data type

boolean

Alias
UMLS CUI [1]
C0220952
Subject must have an IVRS HAM-D 17 total score of >=18 at the Screening Visit, as assessed via an Interactive Voice Response (IVR) rating system
Description

IVRS HAM-D 17

Data type

boolean

Alias
UMLS CUI [1]
C3639712
Subject must have a CGI Severity of Illness score of >=4 at the Screening Visit.
Description

CGI Severity of Illness

Data type

boolean

Alias
UMLS CUI [1]
C3639887
Subject is male or female subject is of: A. non child-bearing potential (i.e. physiologically incapable of becoming pregnant) including any female who is pre-menarchal, post-menopausal or surgically sterile (via hysterectomy, ovariectomy or bilateral ligation); or, B. child-bearing potential, has a negative serum pregnancy test at the Screening Visit and agrees to one of the following: - complete abstinence from intercourse from the Screening Visit throughout the treatment phase of the study, and for a period of at least 7 days after completion of the study or early withdrawal from the study, or, - has a male sexual partner who is surgically sterilized, or, - use of implants of levonorgesterel, or, - use of injectable progesterone, or, - use of oral contraceptive (combined or progesterone only), or, - use of double-barrier contraception, specifically, a spermicide plus a mechanical barrier (e.g. male condom, female diaphragm), or, - use of any intrauterine device (IUD) with published data showing that the highest expected failure rate is less than 1% per year, or, - use of any other method of contraception with data documented in the product labelling as approved by regulatory agencies, or in the absence of approved labelling, in peer reviewed studies, showing that the highest expected failure rate for that method is less than 1% per year.
Description

no risk of pregnancy

Data type

boolean

Alias
UMLS CUI [1,1]
C3839721
UMLS CUI [1,2]
C1298908
Screening Visit Exclusion Criteria
Description

Screening Visit Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Subjects whose symptoms of the presenting illness are better accounted for by another diagnosis.
Description

Differential diagnosis higher propability

Data type

boolean

Alias
UMLS CUI [1,1]
C0011906
UMLS CUI [1,2]
C0033204
Subject with a history of manic episodes.
Description

Medical history of manic disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0024713
Subject with a past or current DSM-IV diagnosis of Schizophrenia or any other psychotic disorder(s).
Description

Schizophrenia or other psychotic disorder

Data type

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0033975
Subject with a current DSM-IV Axis II diagnosis that would suggest non-responsiveness to pharmacotherapy or non-compliance with the protocol (e.g. antisocial or borderline personality disorders).
Description

DSM-IV | non-responsiveness to pharmacotherapy | non-compliance

Data type

boolean

Alias
UMLS CUI [1]
C0220952
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C3845159
UMLS CUI [3]
C0457432
Subject has a diagnosis of anorexia nervosa or bulimia within the last 12 months.
Description

anorexia nervosa | bulimia

Data type

boolean

Alias
UMLS CUI [1]
C0003125
UMLS CUI [2]
C2267227
Subjects whose depressive symptoms are due to the direct physiological effects of a general medical condition (e.g. hypothyroidism, Parkinson's disease, chronic pain).
Description

Reason for depressive symptoms due to physiological effects of a general medical condition

Data type

boolean

Alias
UMLS CUI [1,1]
C0086132
UMLS CUI [1,2]
C2359476
Subject who, in the investigator's judgement, poses a homicidal or serious suicidal risk, has made a suicide attempt within 6 months prior to the Screening Visit or who has ever been homicidal.
Description

homicidal risk, suicidal risk, suicide attempt

Data type

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0745031
UMLS CUI [2]
C0563664
UMLS CUI [3]
C0277662
UMLS CUI [4]
C0038663
Subjects with current or past history of seizure disorder or brain injury (traumatic or disease-related); or any condition which, in the opinion of the investigator, predisposes to seizure; those treated with other medications or treatment regimes that lower seizure threshold; those undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines or benzodiazepine-like agents). Note: single childhood febrile seizure is not exclusionary.
Description

seizure disorder | brain injury | undergoing abrupt discontinuation of alcohol or sedatives

Data type

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2]
C0270611
UMLS CUI [3]
C0236663
UMLS CUI [4,1]
C0457454
UMLS CUI [4,2]
C0036557
Subject has had a myocardial infarction within 1 year prior to the Screening Visit or has a history of uncontrolled hypertension or unstable heart disease within the 6 months prior to the Screening Visit.
Description

myocardial infarction | uncontrolled hypertension | unstable heart disease

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C1868885
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0443343
Subject has an unstable medical disorder; or a disorder that would interfere with the action, absorption, distribution, metabolism, or excretion of bupropion hydrochloride or venlafaxine hydrochloride; may pose a safety concern; or interfere with the accurate assessment of safety or efficacy. Subjects with co-morbidities e.g. diabetes, high blood pressure, hypothyroidism, chronic respiratory or other medical conditions are eligible if their condition has been stable for at least 3 months and they have been receiving standard therapy for the condition for at least 3 months
Description

Unstable medical disorder | bupropion hydrochloride or venlafaxine hydrochloride interaction

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0700563
UMLS CUI [2,2]
C0687133
UMLS CUI [3,1]
C0078569
UMLS CUI [3,2]
C0687133
Subject has a history of a medically significant adverse effect (including allergic reaction) from either bupropion hydrochloride, venlafaxine hydrochloride, their excipients or closely related compounds.
Description

medically significant adverse effects bupropion hydrochloride | medically significant adverse effects venlafaxine hydrochloride |

Data type

boolean

Alias
UMLS CUI [1,1]
C0700563
UMLS CUI [1,2]
C0879626
UMLS CUI [2,1]
C0078569
UMLS CUI [2,2]
C0879626
Subject has a history of a medically significant adverse effect (including allergic reaction) from either bupropion hydrochloride, venlafaxine hydrochloride, their excipients or closely related compounds.
Description

bupropion hydrochloride or venlafaxine hydrochloride interaction

Data type

boolean

Alias
UMLS CUI [1,1]
C0700563
UMLS CUI [1,2]
C0687133
UMLS CUI [2,1]
C0078569
UMLS CUI [2,2]
C0687133
Subjects who have taken bupropion hydrochloride or venlafaxine hydrochloride in the last 6 months.
Description

bupropion hydrochloride | venlafaxine hydrochloride

Data type

boolean

Alias
UMLS CUI [1]
C0700563
UMLS CUI [2]
C0078569
Subject has initiated psychotherapy within 3 months prior to the Screening Visit, or plans to initiate psychotherapy during the study
Description

psychotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0033968
Subject has received electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the 6 months prior to the Screening Visit.
Description

electroconvulsive therapy | transcranial magnetic stimulation

Data type

boolean

Alias
UMLS CUI [1]
C0013806
UMLS CUI [2]
C0436548
Subject has previously failed adequate courses (e.g. maximum labelled doses for >=4 weeks) of pharmacotherapy with two different classes of antidepressants.
Description

failed adequate courses of pharmacotherapy | antidepressants

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C0003289
UMLS CUI [2,2]
C1705242
Subject has a positive urine test at the Screening Visit for illicit drug use and/or a history of alcohol or substance abuse or dependence within the past 12 months or subject has a blood alcohol level of >=15 mg/dl (0.015%) at the Screening Visit.
Description

Note - subjects must be told to avoid consumption of alcoholic beverages for at least 8 hours prior to their Screening Visit. A positive urine test may not be repeated.

Data type

boolean

Alias
UMLS CUI [1]
C0202274
UMLS CUI [2]
C0038586
Subject has any of the laboratory results shown on page 28 of the Protocol (testing may be repeated once to see if the value returns to within the range specified) or subject has any abnormal laboratory finding that is thought to be clinically significant (regardless of the degree out of normal range)
Description

Note: Subjects maintained on thyroid medication must be euthyroid for a period of at least 3 months prior to the Screening Visit

Data type

boolean

Alias
UMLS CUI [1]
C0438215
Subject has ECG or clinical evidence of atrial or ventricular hypertrophy; intraventricular conduction defects (excluding incomplete right bundle branch block in the absence of clinical evidence of heart disease); myocardial strain, ischaemia or infarct; atrial arrythmia (must be in normal sinus rhythm); second- or third-degree AV block; congestive heart failure; cor pulmonale; any cardiac condition that the investigator feels may predispose the subject to ischaemia or arrythmia.
Description

heart diseases

Data type

boolean

Alias
UMLS CUI [1]
C0018799
Subject has systolic blood pressure >=150 mmHg or diastolic blood pressure >=95 mmHg at the Screening Visit.
Description

systolic blood pressure | diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
Female subject who is pregnant, lactating or who is planning to become pregnant during the course of the study.
Description

pregnancy | lactation | pregnancy, planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
Subject is currently participating in another clinical study in which the subject is or will be exposed to an investigational or non-investigational drug or device, or has done so within the preceding month for studies unrelated to the current illness, or 6 months for studies related to the current illness.
Description

Clinical trial participation

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Subject, in the opinion of the investigator, is likely to be non-compliant with the study visit schedule or with the study procedures (e.g. illiteracy, planned vacations, planned hospitalisations during the course of the study, poor medicine compliance, etc.)
Description

Compliance behaviour

Data type

boolean

Alias
UMLS CUI [1]
C1321605
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Similar models

Visit 1 (Screening): Eligibility Criteria

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Screening Visit Inclusion Criteria
C1512693 (UMLS CUI-1)
Informed constent
Item
Subject must have the ability to comprehend the key components of the consent form and must provide their written informed consent to participate in the study prior to any study-specific assessments or procedures.
boolean
C0021430 (UMLS CUI [1])
outpatient | age
Item
Subject must be an outpatient (male or female) and must be aged between 18 and 64 years (inclusive).
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Major Depressive Disorder: single episode/recurrent
Item
Subject has a diagnosis of Major Depressive Disorder, single episode or recurrent, DSM-IV (296.2/296.3) diagnosed with comprehensive psychiatric evaluation as assessed* by a physician with adequate training in psychiatry (e.g. Board Certification in US; Certificate of Completion of Specialist Training in EU).
boolean
C0024517 (UMLS CUI [1])
C1269683 (UMLS CUI [2,1])
C0443287 (UMLS CUI [2,2])
DSM IV criteria for current major depressive episode
Item
In the Investigator's opinion, the subject must have met DSM-IV criteria for their current major depressive episode for at least 8 weeks
boolean
C0220952 (UMLS CUI [1])
IVRS HAM-D 17
Item
Subject must have an IVRS HAM-D 17 total score of >=18 at the Screening Visit, as assessed via an Interactive Voice Response (IVR) rating system
boolean
C3639712 (UMLS CUI [1])
CGI Severity of Illness
Item
Subject must have a CGI Severity of Illness score of >=4 at the Screening Visit.
boolean
C3639887 (UMLS CUI [1])
no risk of pregnancy
Item
Subject is male or female subject is of: A. non child-bearing potential (i.e. physiologically incapable of becoming pregnant) including any female who is pre-menarchal, post-menopausal or surgically sterile (via hysterectomy, ovariectomy or bilateral ligation); or, B. child-bearing potential, has a negative serum pregnancy test at the Screening Visit and agrees to one of the following: - complete abstinence from intercourse from the Screening Visit throughout the treatment phase of the study, and for a period of at least 7 days after completion of the study or early withdrawal from the study, or, - has a male sexual partner who is surgically sterilized, or, - use of implants of levonorgesterel, or, - use of injectable progesterone, or, - use of oral contraceptive (combined or progesterone only), or, - use of double-barrier contraception, specifically, a spermicide plus a mechanical barrier (e.g. male condom, female diaphragm), or, - use of any intrauterine device (IUD) with published data showing that the highest expected failure rate is less than 1% per year, or, - use of any other method of contraception with data documented in the product labelling as approved by regulatory agencies, or in the absence of approved labelling, in peer reviewed studies, showing that the highest expected failure rate for that method is less than 1% per year.
boolean
C3839721 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
Item Group
Screening Visit Exclusion Criteria
C0680251 (UMLS CUI-1)
Differential diagnosis higher propability
Item
Subjects whose symptoms of the presenting illness are better accounted for by another diagnosis.
boolean
C0011906 (UMLS CUI [1,1])
C0033204 (UMLS CUI [1,2])
Medical history of manic disorders
Item
Subject with a history of manic episodes.
boolean
C0262926 (UMLS CUI [1,1])
C0024713 (UMLS CUI [1,2])
Schizophrenia or other psychotic disorder
Item
Subject with a past or current DSM-IV diagnosis of Schizophrenia or any other psychotic disorder(s).
boolean
C0036341 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
DSM-IV | non-responsiveness to pharmacotherapy | non-compliance
Item
Subject with a current DSM-IV Axis II diagnosis that would suggest non-responsiveness to pharmacotherapy or non-compliance with the protocol (e.g. antisocial or borderline personality disorders).
boolean
C0220952 (UMLS CUI [1])
C0013216 (UMLS CUI [2,1])
C3845159 (UMLS CUI [2,2])
C0457432 (UMLS CUI [3])
anorexia nervosa | bulimia
Item
Subject has a diagnosis of anorexia nervosa or bulimia within the last 12 months.
boolean
C0003125 (UMLS CUI [1])
C2267227 (UMLS CUI [2])
Reason for depressive symptoms due to physiological effects of a general medical condition
Item
Subjects whose depressive symptoms are due to the direct physiological effects of a general medical condition (e.g. hypothyroidism, Parkinson's disease, chronic pain).
boolean
C0086132 (UMLS CUI [1,1])
C2359476 (UMLS CUI [1,2])
homicidal risk, suicidal risk, suicide attempt
Item
Subject who, in the investigator's judgement, poses a homicidal or serious suicidal risk, has made a suicide attempt within 6 months prior to the Screening Visit or who has ever been homicidal.
boolean
C0035647 (UMLS CUI [1,1])
C0745031 (UMLS CUI [1,2])
C0563664 (UMLS CUI [2])
C0277662 (UMLS CUI [3])
C0038663 (UMLS CUI [4])
seizure disorder | brain injury | undergoing abrupt discontinuation of alcohol or sedatives
Item
Subjects with current or past history of seizure disorder or brain injury (traumatic or disease-related); or any condition which, in the opinion of the investigator, predisposes to seizure; those treated with other medications or treatment regimes that lower seizure threshold; those undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines or benzodiazepine-like agents). Note: single childhood febrile seizure is not exclusionary.
boolean
C0014544 (UMLS CUI [1])
C0270611 (UMLS CUI [2])
C0236663 (UMLS CUI [3])
C0457454 (UMLS CUI [4,1])
C0036557 (UMLS CUI [4,2])
myocardial infarction | uncontrolled hypertension | unstable heart disease
Item
Subject has had a myocardial infarction within 1 year prior to the Screening Visit or has a history of uncontrolled hypertension or unstable heart disease within the 6 months prior to the Screening Visit.
boolean
C0027051 (UMLS CUI [1])
C1868885 (UMLS CUI [2])
C0018799 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
Unstable medical disorder | bupropion hydrochloride or venlafaxine hydrochloride interaction
Item
Subject has an unstable medical disorder; or a disorder that would interfere with the action, absorption, distribution, metabolism, or excretion of bupropion hydrochloride or venlafaxine hydrochloride; may pose a safety concern; or interfere with the accurate assessment of safety or efficacy. Subjects with co-morbidities e.g. diabetes, high blood pressure, hypothyroidism, chronic respiratory or other medical conditions are eligible if their condition has been stable for at least 3 months and they have been receiving standard therapy for the condition for at least 3 months
boolean
C0012634 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0700563 (UMLS CUI [2,1])
C0687133 (UMLS CUI [2,2])
C0078569 (UMLS CUI [3,1])
C0687133 (UMLS CUI [3,2])
medically significant adverse effects bupropion hydrochloride | medically significant adverse effects venlafaxine hydrochloride |
Item
Subject has a history of a medically significant adverse effect (including allergic reaction) from either bupropion hydrochloride, venlafaxine hydrochloride, their excipients or closely related compounds.
boolean
C0700563 (UMLS CUI [1,1])
C0879626 (UMLS CUI [1,2])
C0078569 (UMLS CUI [2,1])
C0879626 (UMLS CUI [2,2])
bupropion hydrochloride or venlafaxine hydrochloride interaction
Item
Subject has a history of a medically significant adverse effect (including allergic reaction) from either bupropion hydrochloride, venlafaxine hydrochloride, their excipients or closely related compounds.
boolean
C0700563 (UMLS CUI [1,1])
C0687133 (UMLS CUI [1,2])
C0078569 (UMLS CUI [2,1])
C0687133 (UMLS CUI [2,2])
bupropion hydrochloride | venlafaxine hydrochloride
Item
Subjects who have taken bupropion hydrochloride or venlafaxine hydrochloride in the last 6 months.
boolean
C0700563 (UMLS CUI [1])
C0078569 (UMLS CUI [2])
psychotherapy
Item
Subject has initiated psychotherapy within 3 months prior to the Screening Visit, or plans to initiate psychotherapy during the study
boolean
C0033968 (UMLS CUI [1])
electroconvulsive therapy | transcranial magnetic stimulation
Item
Subject has received electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the 6 months prior to the Screening Visit.
boolean
C0013806 (UMLS CUI [1])
C0436548 (UMLS CUI [2])
failed adequate courses of pharmacotherapy | antidepressants
Item
Subject has previously failed adequate courses (e.g. maximum labelled doses for >=4 weeks) of pharmacotherapy with two different classes of antidepressants.
boolean
C0013216 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0003289 (UMLS CUI [2,1])
C1705242 (UMLS CUI [2,2])
urine drug test | alcohol abuse | drug abuse
Item
Subject has a positive urine test at the Screening Visit for illicit drug use and/or a history of alcohol or substance abuse or dependence within the past 12 months or subject has a blood alcohol level of >=15 mg/dl (0.015%) at the Screening Visit.
boolean
C0202274 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
abnormal laboratory findings
Item
Subject has any of the laboratory results shown on page 28 of the Protocol (testing may be repeated once to see if the value returns to within the range specified) or subject has any abnormal laboratory finding that is thought to be clinically significant (regardless of the degree out of normal range)
boolean
C0438215 (UMLS CUI [1])
heart diseases
Item
Subject has ECG or clinical evidence of atrial or ventricular hypertrophy; intraventricular conduction defects (excluding incomplete right bundle branch block in the absence of clinical evidence of heart disease); myocardial strain, ischaemia or infarct; atrial arrythmia (must be in normal sinus rhythm); second- or third-degree AV block; congestive heart failure; cor pulmonale; any cardiac condition that the investigator feels may predispose the subject to ischaemia or arrythmia.
boolean
C0018799 (UMLS CUI [1])
systolic blood pressure | diastolic blood pressure
Item
Subject has systolic blood pressure >=150 mmHg or diastolic blood pressure >=95 mmHg at the Screening Visit.
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
pregnancy | lactation | pregnancy, planned
Item
Female subject who is pregnant, lactating or who is planning to become pregnant during the course of the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Clinical trial participation
Item
Subject is currently participating in another clinical study in which the subject is or will be exposed to an investigational or non-investigational drug or device, or has done so within the preceding month for studies unrelated to the current illness, or 6 months for studies related to the current illness.
boolean
C2348568 (UMLS CUI [1])
Compliance behaviour
Item
Subject, in the opinion of the investigator, is likely to be non-compliant with the study visit schedule or with the study procedures (e.g. illiteracy, planned vacations, planned hospitalisations during the course of the study, poor medicine compliance, etc.)
boolean
C1321605 (UMLS CUI [1])
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