Duloxetine for Chronic Depression: a Double-blind Study
Study Details
Study Description
Brief Summary
The investigators are studying a new antidepressant medicine, duloxetine, for the treatment of people with chronic depression. Duloxetine (trade name Cymbalta) was recently approved by the FDA for the treatment of major depression. The investigators are testing whether this medicine is also effective for adults with chronic depression (dysthymic disorder or dysthymia).
Chronic depression, lasting two or more years, often causes significant suffering and impairment. The investigators study involves a 6 to 10 week double-blind Initial Phase during which half of the participants will take the new medication and half will take a placebo (an inactive look-alike pill). After the Initial Phase, a 12-week Continuation Phase will begin, during which all subjects can be treated with an FDA-approved antidepressant medication.
Eligible subjects may also receive MRI scans, to help the investigators understand how antidepressants work in treating depression.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Detailed Description
This is a 22-week study of the tolerability, dosing, and efficacy of duloxetine in chronically depressed outpatients. Participants can have Dysthymic Disorder (Dysthymia), or Depression, Not Otherwise Specified (Depression NOS).
The first 10 weeks (Acute Phase) are double blind, placebo-controlled, and the second 12 weeks (Continuation Phase) is open-label and all subjects will receive active medication.
Tests of cytokine functioning will be performed and analyzed for treatment and placebo effects.
In addition, a subset of patients will be enrolled into an Magnetic Resonance Imaging (MRI) sub-study, in which a variety of brain imaging techniques (including anatomical MRI, functional MRI (fMRI), MR Spectroscopy, and Diffusion Tensor Imaging) will be performed at baseline and week 10. Duloxetine responders will have a third MRI performed at week 22.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: duloxetine (cymbalta) Duloxetine medication: a medication currently marketed in the USA that is reported to have pharmacological effects including reuptake blockage for serotonin and norepinephrine |
Drug: Duloxetine (Cymbalta)
duloxetine medication up to dose of 120 mg/day
Other Names:
|
Placebo Comparator: Placebo treatment placebo treatment: treatment with placebo capsules that match active medication capsules |
Drug: Duloxetine (Cymbalta)
duloxetine medication up to dose of 120 mg/day
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Hamilton Depression Rating Scale (HDRS) - 24 Total Score [Week 10]
HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression
- Hamilton Depression Rating Scale (HDRS) - 24 Total Score [Baseline]
HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression
Secondary Outcome Measures
- Cornell Dysthymia Rating Scale (CDRS) [Week 10]
CDRS is a 20-item clinician-rated inventory for chronic depressive symptoms. Each item was characterized by an explanatory or illustrative description and rated from 0 (symptom absent) to 4 (severe symptoms). Scores from 0 to 82 with higher score indicating worse depression
- Global Assessment of Functioning Scale (GAF) [Week 10]
A commonly used rating scale for global social function. Range from 0 to 100; higher score=better functioning. 91 - 100 No symptoms. 81 - 90 Absent or minimal symptoms 71 - 80 no more than slight impairment in social, occupational, or school functioning (e.g., temporarily falling behind in schoolwork). 61 - 70 Some mild symptoms 51 - 60 Moderate symptoms 41 - 50 Serious symptoms 31 - 40 Some impairment in reality testing or communication 21 - 30 Behavior is considerably influenced by delusions or hallucinations or serious impairment, in communication or judgment 11 - 20 Some danger of hurting self or others 1 - 10 Persistent danger of severely hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. 0 Inadequate information
- Beck Depression Inventory (BDI) [Week 10]
Beck Depression Inventory (BDI)is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:[7] 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. Higher total scores indicate more severe depressive symptoms.
- Clinical Global Impressions Improvement(CGI-I) [10 weeks]
The Clinical Global Impression - Improvement(CGI-I) is a 7-point scale that rate patient's total improvement whether or not comparing to his/her condition at baseline. 0 = Not assessed = Very much improved = Much improved = Minimally improved = No change = Minimally worse = Much worse = Very much worse Higher score=greatest worsening
- Cornell Dysthymia Rating Scale (CDRS) [Baseline]
CDRS is a 20-item clinician-rated inventory for chronic depressive symptoms. Each item was characterized by an explanatory or illustrative description and rated from 0 (symptom absent) to 4 (severe symptoms). Scores from 0 to 82 with higher score indicating worse depression
- Beck Depression Inventory (BDI) [Baseline]
Beck Depression Inventory (BDI)is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:[7] 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. Higher total scores indicate more severe depressive symptoms.
- Global Assessment of Functioning Scale (GAF) [Baseline]
A commonly used rating scale for global social function. Range from 0 to 100; higher score=better functioning. 91 - 100 No symptoms. 81 - 90 Absent or minimal symptoms 71 - 80 no more than slight impairment in social, occupational, or school functioning (e.g., temporarily falling behind in schoolwork). 61 - 70 Some mild symptoms 51 - 60 Moderate symptoms 41 - 50 Serious symptoms 31 - 40 Some impairment in reality testing or communication 21 - 30 Behavior is considerably influenced by delusions or hallucinations or serious impairment, in communication or judgment 11 - 20 Some danger of hurting self or others 1 - 10 Persistent danger of severely hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. 0 Inadequate information
Other Outcome Measures
- Resting-state Functional Connectivity Magnetic Resonance Imaging(fMRI) [Baseline]
To use resting-state fMRI to study the effects of antidepressant therapy on default mode network (DMN) connectivity density.
- Resting-state Functional Connectivity Magnetic Resonance Imaging(fMRI) [Follow up]
To use resting-state fMRI to study the effects of antidepressant therapy on default mode network (DMN) connectivity density.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
age 20 to 75 years (ages 20 to 60 for MRI sub-study)
-
diagnosis of dysthymic disorder (chronic depression) or depression NOS
-
minimum of 2 years duration of current episode of depression
Exclusion Criteria:
-
current major depression
-
diagnoses including delirium, dementia, bipolar disorder, schizophrenia
-
substance abuse or dependence in the past 6 months
-
pregnant or nursing women
-
serious risk of suicide
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | New York State Psychiatric Institute | New York | New York | United States | 10032 |
Sponsors and Collaborators
- New York State Psychiatric Institute
- Eli Lilly and Company
Investigators
- Principal Investigator: David J. Hellerstein, MD, New York State Psychiatric Institute
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- # 4967/6363R
Study Results
Participant Flow
Recruitment Details | Subjects were recruited by advertisements, website postings, and from the hospital's telephone referral service. Conducted between August 2006 and December 2011. Potential participants provided informed consent for study participation. A physical examination was performed and blood and urine samples were collected, including urine toxicology. |
---|---|
Pre-assignment Detail | For patients on current ineffective psychotropic medication, washout was required, with >=7 days medication-free (>=28 days for fluoxetine). Concurrent sleep medication (zolpidem) was allowed for a maximum of 5 days during the study. |
Arm/Group Title | Duloxetine (Cymbalta) | Placebo Treatment |
---|---|---|
Arm/Group Description | Duloxetine medication, ranging from 30 to 120 mg/day | placebo treatment, treatment with matching capsules of placebo |
Period Title: Overall Study | ||
STARTED | 33 | 32 |
COMPLETED | 29 | 28 |
NOT COMPLETED | 4 | 4 |
Baseline Characteristics
Arm/Group Title | Duloxetine (Cymbalta) | Placebo Treatment | Total |
---|---|---|---|
Arm/Group Description | Duloxetine medication, ranging from 30 to 120 mg/day | placebo treatment: treatment with placebo capsules that match active medication capsules | Total of all reporting groups |
Overall Participants | 33 | 32 | 65 |
Age (Count of Participants) | |||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
32
97%
|
32
100%
|
64
98.5%
|
>=65 years |
1
3%
|
0
0%
|
1
1.5%
|
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
41
(11.7)
|
42.1
(11.4)
|
41.6
(11.2)
|
Sex: Female, Male (Count of Participants) | |||
Female |
18
54.5%
|
10
31.3%
|
28
43.1%
|
Male |
15
45.5%
|
22
68.8%
|
37
56.9%
|
Region of Enrollment (participants) [Number] | |||
United States |
33
100%
|
32
100%
|
65
100%
|
Outcome Measures
Title | Hamilton Depression Rating Scale (HDRS) - 24 Total Score |
---|---|
Description | HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression |
Time Frame | Week 10 |
Outcome Measure Data
Analysis Population Description |
---|
Patients for whom post-baseline data was available and scored 2 or less on the suicide item either at baseline or during the course of treatment. |
Arm/Group Title | Duloxetine (Cymbalta) | Placebo Treatment |
---|---|---|
Arm/Group Description | Duloxetine medication, ranging from 30 to 120 mg/day | placebo treatment, with capsules matching the duloxetine medication |
Measure Participants | 29 | 28 |
Mean (Standard Deviation) [Scores on a scale] |
5
(3.6)
|
10
(5.5)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Duloxetine (Cymbalta), Placebo Treatment |
---|---|---|
Comments | Repeated measures ANOVA was used to compare measures between baseline and week 10. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | .003 |
Comments | ||
Method | Repeated Measures ANOVA | |
Comments | df 1,55 | |
Method of Estimation | Estimation Parameter | F statistics |
Estimated Value | 9.43 | |
Confidence Interval |
() % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | time X Drug group, f=9.43,df 1,55, p=.003 |
Title | Hamilton Depression Rating Scale (HDRS) - 24 Total Score |
---|---|
Description | HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression |
Time Frame | Baseline |
Outcome Measure Data
Analysis Population Description |
---|
Patients for whom post-baseline data was available and scored 2 or less on the suicide item either at baseline or during the course of treatment. |
Arm/Group Title | Duloxetine (Cymbalta) | Placebo Treatment |
---|---|---|
Arm/Group Description | Duloxetine medication, ranging from 30 to 120 mg/day | placebo treatment, with capsules matching the duloxetine medication |
Measure Participants | 29 | 28 |
Mean (Standard Deviation) [Scores on a scale] |
14.1
(3.8)
|
14.9
(3.5)
|
Title | Cornell Dysthymia Rating Scale (CDRS) |
---|---|
Description | CDRS is a 20-item clinician-rated inventory for chronic depressive symptoms. Each item was characterized by an explanatory or illustrative description and rated from 0 (symptom absent) to 4 (severe symptoms). Scores from 0 to 82 with higher score indicating worse depression |
Time Frame | Week 10 |
Outcome Measure Data
Analysis Population Description |
---|
subjects for whom data post baseline were available |
Arm/Group Title | Duloxetine (Cymbalta) | Placebo Treatment |
---|---|---|
Arm/Group Description | Duloxetine medication, ranging from 30 to 120 mg/day | placebo treatment: treatment with placebo capsules that match active medication capsules |
Measure Participants | 29 | 28 |
Mean (Standard Deviation) [scores on a scale] |
19.1
(9.5)
|
28.5
(14.6)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Duloxetine (Cymbalta), Placebo Treatment |
---|---|---|
Comments | Repeated measures ANOVA was used to compare measures between baseline and week 10. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.05 |
Comments | ||
Method | Repeated Measures ANOVA | |
Comments | d.f. 1,55 | |
Method of Estimation | Estimation Parameter | F statistics |
Estimated Value | 8.72 | |
Confidence Interval |
() % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Time x Treatment: F=8.72, d.f=1,55, p=0.05 |
Title | Global Assessment of Functioning Scale (GAF) |
---|---|
Description | A commonly used rating scale for global social function. Range from 0 to 100; higher score=better functioning. 91 - 100 No symptoms. 81 - 90 Absent or minimal symptoms 71 - 80 no more than slight impairment in social, occupational, or school functioning (e.g., temporarily falling behind in schoolwork). 61 - 70 Some mild symptoms 51 - 60 Moderate symptoms 41 - 50 Serious symptoms 31 - 40 Some impairment in reality testing or communication 21 - 30 Behavior is considerably influenced by delusions or hallucinations or serious impairment, in communication or judgment 11 - 20 Some danger of hurting self or others 1 - 10 Persistent danger of severely hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. 0 Inadequate information |
Time Frame | Week 10 |
Outcome Measure Data
Analysis Population Description |
---|
subjects for whom post-baseline data were available |
Arm/Group Title | Duloxetine (Cymbalta) | Placebo Treatment |
---|---|---|
Arm/Group Description | Duloxetine medication, ranging from 30 to 120 mg/day | placebo treatment: treatment with placebo capsules that match active medication capsules |
Measure Participants | 29 | 28 |
Mean (Standard Deviation) [points on rating scale] |
69.9
(20.9)
|
65.7
(14)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Duloxetine (Cymbalta), Placebo Treatment |
---|---|---|
Comments | Repeated measures ANOVA was used to compare measures between baseline and week 10. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.025 |
Comments | ||
Method | Repeated measures ANOVA | |
Comments | d.f. 1,55 | |
Method of Estimation | Estimation Parameter | F statistics |
Estimated Value | 5.33 | |
Confidence Interval |
() % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Beck Depression Inventory (BDI) |
---|---|
Description | Beck Depression Inventory (BDI)is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:[7] 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. Higher total scores indicate more severe depressive symptoms. |
Time Frame | Week 10 |
Outcome Measure Data
Analysis Population Description |
---|
subjects fro whom post-baseline data was available |
Arm/Group Title | Duloxetine (Cymbalta) | Placebo Treatment |
---|---|---|
Arm/Group Description | Duloxetine medication, ranging from 30 to 120 mg/day | placebo treatment: treatment with placebo capsules that match active medication capsules |
Measure Participants | 29 | 28 |
Mean (Standard Deviation) [Scores on a scale] |
8.5
(7)
|
10.1
(6.2)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Duloxetine (Cymbalta), Placebo Treatment |
---|---|---|
Comments | Repeated measures ANOVA was used to compare measures between baseline and week 10. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.6 |
Comments | ||
Method | Repeated measures ANOVA | |
Comments | d.f.=1,55 | |
Method of Estimation | Estimation Parameter | F statistics |
Estimated Value | 0.26 | |
Confidence Interval |
() % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Clinical Global Impressions Improvement(CGI-I) |
---|---|
Description | The Clinical Global Impression - Improvement(CGI-I) is a 7-point scale that rate patient's total improvement whether or not comparing to his/her condition at baseline. 0 = Not assessed = Very much improved = Much improved = Minimally improved = No change = Minimally worse = Much worse = Very much worse Higher score=greatest worsening |
Time Frame | 10 weeks |
Outcome Measure Data
Analysis Population Description |
---|
subjects for whom post-baseline data was available |
Arm/Group Title | Duloxetine (Cymbalta) | Placebo Treatment |
---|---|---|
Arm/Group Description | Duloxetine medication, ranging from 30 to 120 mg/day | placebo treatment: treatment with placebo capsules that match active medication capsules |
Measure Participants | 29 | 28 |
Mean (Standard Deviation) [Scores on a scale] |
2.4
(.8)
|
3
(1.1)
|
Title | Cornell Dysthymia Rating Scale (CDRS) |
---|---|
Description | CDRS is a 20-item clinician-rated inventory for chronic depressive symptoms. Each item was characterized by an explanatory or illustrative description and rated from 0 (symptom absent) to 4 (severe symptoms). Scores from 0 to 82 with higher score indicating worse depression |
Time Frame | Baseline |
Outcome Measure Data
Analysis Population Description |
---|
subjects for whom data post baseline were available |
Arm/Group Title | Duloxetine (Cymbalta) | Placebo Treatment |
---|---|---|
Arm/Group Description | Duloxetine medication, ranging from 30 to 120 mg/day | placebo treatment: treatment with placebo capsules that match active medication capsules |
Measure Participants | 29 | 28 |
Mean (Standard Deviation) [Scores on a scale] |
36.9
(8.0)
|
37.4
(8.0)
|
Title | Beck Depression Inventory (BDI) |
---|---|
Description | Beck Depression Inventory (BDI)is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:[7] 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. Higher total scores indicate more severe depressive symptoms. |
Time Frame | Baseline |
Outcome Measure Data
Analysis Population Description |
---|
subjects for whom post-baseline data was available |
Arm/Group Title | Duloxetine (Cymbalta) | Placebo Treatment |
---|---|---|
Arm/Group Description | Duloxetine medication, ranging from 30 to 120 mg/day | placebo treatment: treatment with placebo capsules that match active medication capsules |
Measure Participants | 29 | 28 |
Mean (Standard Deviation) [Scores on a scale] |
12.7
(5.8)
|
15.5
(5.5)
|
Title | Global Assessment of Functioning Scale (GAF) |
---|---|
Description | A commonly used rating scale for global social function. Range from 0 to 100; higher score=better functioning. 91 - 100 No symptoms. 81 - 90 Absent or minimal symptoms 71 - 80 no more than slight impairment in social, occupational, or school functioning (e.g., temporarily falling behind in schoolwork). 61 - 70 Some mild symptoms 51 - 60 Moderate symptoms 41 - 50 Serious symptoms 31 - 40 Some impairment in reality testing or communication 21 - 30 Behavior is considerably influenced by delusions or hallucinations or serious impairment, in communication or judgment 11 - 20 Some danger of hurting self or others 1 - 10 Persistent danger of severely hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. 0 Inadequate information |
Time Frame | Baseline |
Outcome Measure Data
Analysis Population Description |
---|
subjects for whom post-baseline data were available |
Arm/Group Title | Duloxetine (Cymbalta) | Placebo Treatment |
---|---|---|
Arm/Group Description | Duloxetine medication, ranging from 30 to 120 mg/day | placebo treatment: treatment with placebo capsules that match active medication capsules |
Measure Participants | 29 | 28 |
Mean (Standard Deviation) [points on rating scale] |
62.6
(5.8)
|
58.3
(7.0)
|
Title | Resting-state Functional Connectivity Magnetic Resonance Imaging(fMRI) |
---|---|
Description | To use resting-state fMRI to study the effects of antidepressant therapy on default mode network (DMN) connectivity density. |
Time Frame | Baseline |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Duloxetine (Cymbalta) | Placebo Treatment |
---|---|---|
Arm/Group Description | Duloxetine medication: a medication currently marketed in the USA that is reported to have pharmacological effects including reuptake blockage for serotonin and norepinephrine Duloxetine (Cymbalta): duloxetine medication up to dose of 120 mg/day | placebo treatment: treatment with placebo capsules that match active medication capsules Duloxetine (Cymbalta): duloxetine medication up to dose of 120 mg/day |
Measure Participants | 15 | 17 |
Mean (Standard Deviation) [percentage of connecting nods] |
0.21
(0.08)
|
0.24
(0.06)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Duloxetine (Cymbalta), Placebo Treatment |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.002 |
Comments | ||
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 4.0 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Resting-state Functional Connectivity Magnetic Resonance Imaging(fMRI) |
---|---|
Description | To use resting-state fMRI to study the effects of antidepressant therapy on default mode network (DMN) connectivity density. |
Time Frame | Follow up |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Duloxetine (Cymbalta) | Placebo Treatment |
---|---|---|
Arm/Group Description | Duloxetine medication: a medication currently marketed in the USA that is reported to have pharmacological effects including reuptake blockage for serotonin and norepinephrine Duloxetine (Cymbalta): duloxetine medication up to dose of 120 mg/day | placebo treatment: treatment with placebo capsules that match active medication capsules Duloxetine (Cymbalta): duloxetine medication up to dose of 120 mg/day |
Measure Participants | 15 | 17 |
Mean (Standard Deviation) [percentage of connecting nods] |
0.16
(0.06)
|
0.19
(0.08)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Duloxetine (Cymbalta), Placebo Treatment |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.9 |
Comments | ||
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 0.4 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Adverse Events
Time Frame | patients were treated in study for 22 weeks, including 10 weeks double blind medication vs placebo and 12 weeks open label treatment. | |||
---|---|---|---|---|
Adverse Event Reporting Description | All started participants were assessed for Serious Adverse Events, while only completed participants were assessed for Other Adverse Events. | |||
Arm/Group Title | Duloxetine (Cymbalta) | Placebo Treatment | ||
Arm/Group Description | Duloxetine medication, ranging from 30 to 120 mg/day | placebo treatment: treatment with placebo capsules that match active medication capsules | ||
All Cause Mortality |
||||
Duloxetine (Cymbalta) | Placebo Treatment | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Duloxetine (Cymbalta) | Placebo Treatment | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/33 (0%) | 0/32 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Duloxetine (Cymbalta) | Placebo Treatment | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 27/29 (93.1%) | 22/28 (78.6%) | ||
Gastrointestinal disorders | ||||
GI upset | 7/29 (24.1%) | 7 | 9/28 (32.1%) | 9 |
General disorders | ||||
Fatigue | 9/29 (31%) | 9 | 8/28 (28.6%) | 8 |
Nausea | 6/29 (20.7%) | 6 | 5/28 (17.9%) | 5 |
Dizziness | 2/29 (6.9%) | 2 | 4/28 (14.3%) | 4 |
Decreased Sleep | 6/29 (20.7%) | 6 | 4/28 (14.3%) | 4 |
Decreased Appetite | 8/29 (27.6%) | 8 | 4/28 (14.3%) | 4 |
Vivid Dream | 7/29 (24.1%) | 7 | 1/28 (3.6%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title | David Hellerstein MD |
---|---|
Organization | NY State Psychiatric Institute |
Phone | 6467748000 |
hellers@nyspi.columbia.edu |
- # 4967/6363R