Trial Outcomes & Findings for Duloxetine for Chronic Depression: a Double-blind Study (NCT NCT00360724)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

65 participants

Primary outcome timeframe

Week 10

Results posted on

2017-08-21

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Duloxetine (Cymbalta) Duloxetine medication, ranging from 30 to 120 mg/day	Placebo Treatment placebo treatment, treatment with matching capsules of placebo
Overall Study STARTED	33	32
Overall Study COMPLETED	29	28
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Duloxetine for Chronic Depression: a Double-blind Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Duloxetine (Cymbalta) n=33 Participants Duloxetine medication, ranging from 30 to 120 mg/day	Placebo Treatment n=32 Participants placebo treatment: treatment with placebo capsules that match active medication capsules	Total n=65 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants	32 Participants n=7 Participants	64 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	41 years STANDARD_DEVIATION 11.7 • n=5 Participants	42.1 years STANDARD_DEVIATION 11.4 • n=7 Participants	41.6 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	10 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	22 Participants n=7 Participants	37 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants	32 participants n=7 Participants	65 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 10

Population: 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.

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

Outcome measures

Outcome measures
Measure	Duloxetine (Cymbalta) n=29 Participants Duloxetine medication, ranging from 30 to 120 mg/day	Placebo Treatment n=28 Participants placebo treatment, with capsules matching the duloxetine medication
Hamilton Depression Rating Scale (HDRS) - 24 Total Score	5 Scores on a scale Standard Deviation 3.6	10 Scores on a scale Standard Deviation 5.5

PRIMARY outcome

Timeframe: Baseline

Population: 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.

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

Outcome measures

Outcome measures
Measure	Duloxetine (Cymbalta) n=29 Participants Duloxetine medication, ranging from 30 to 120 mg/day	Placebo Treatment n=28 Participants placebo treatment, with capsules matching the duloxetine medication
Hamilton Depression Rating Scale (HDRS) - 24 Total Score	14.1 Scores on a scale Standard Deviation 3.8	14.9 Scores on a scale Standard Deviation 3.5

SECONDARY outcome

Timeframe: Week 10

Population: subjects for whom data post baseline were available

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

Outcome measures

Outcome measures
Measure	Duloxetine (Cymbalta) n=29 Participants Duloxetine medication, ranging from 30 to 120 mg/day	Placebo Treatment n=28 Participants placebo treatment, with capsules matching the duloxetine medication
Cornell Dysthymia Rating Scale (CDRS)	19.1 scores on a scale Standard Deviation 9.5	28.5 scores on a scale Standard Deviation 14.6

SECONDARY outcome

Timeframe: Week 10

Population: subjects for whom post-baseline data were available

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

Outcome measures

Outcome measures
Measure	Duloxetine (Cymbalta) n=29 Participants Duloxetine medication, ranging from 30 to 120 mg/day	Placebo Treatment n=28 Participants placebo treatment, with capsules matching the duloxetine medication
Global Assessment of Functioning Scale (GAF)	69.9 points on rating scale Standard Deviation 20.9	65.7 points on rating scale Standard Deviation 14

SECONDARY outcome

Timeframe: Week 10

Population: subjects fro whom post-baseline data was available

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.

Outcome measures

Outcome measures
Measure	Duloxetine (Cymbalta) n=29 Participants Duloxetine medication, ranging from 30 to 120 mg/day	Placebo Treatment n=28 Participants placebo treatment, with capsules matching the duloxetine medication
Beck Depression Inventory (BDI)	8.5 Scores on a scale Standard Deviation 7	10.1 Scores on a scale Standard Deviation 6.2

SECONDARY outcome

Timeframe: 10 weeks

Population: subjects for whom post-baseline data was available

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 1. = Very much improved 2. = Much improved 3. = Minimally improved 4. = No change 5. = Minimally worse 6. = Much worse 7. = Very much worse Higher score=greatest worsening

Outcome measures

Outcome measures
Measure	Duloxetine (Cymbalta) n=29 Participants Duloxetine medication, ranging from 30 to 120 mg/day	Placebo Treatment n=28 Participants placebo treatment, with capsules matching the duloxetine medication
Clinical Global Impressions Improvement(CGI-I)	2.4 Scores on a scale Standard Deviation .8	3 Scores on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: Baseline

Population: subjects for whom data post baseline were available

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

Outcome measures

Outcome measures
Measure	Duloxetine (Cymbalta) n=29 Participants Duloxetine medication, ranging from 30 to 120 mg/day	Placebo Treatment n=28 Participants placebo treatment, with capsules matching the duloxetine medication
Cornell Dysthymia Rating Scale (CDRS)	36.9 Scores on a scale Standard Deviation 8.0	37.4 Scores on a scale Standard Deviation 8.0

SECONDARY outcome

Timeframe: Baseline

Population: subjects for whom post-baseline data was available

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.

Outcome measures

Outcome measures
Measure	Duloxetine (Cymbalta) n=29 Participants Duloxetine medication, ranging from 30 to 120 mg/day	Placebo Treatment n=28 Participants placebo treatment, with capsules matching the duloxetine medication
Beck Depression Inventory (BDI)	12.7 Scores on a scale Standard Deviation 5.8	15.5 Scores on a scale Standard Deviation 5.5

SECONDARY outcome

Timeframe: Baseline

Population: subjects for whom post-baseline data were available

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

Outcome measures

Outcome measures
Measure	Duloxetine (Cymbalta) n=29 Participants Duloxetine medication, ranging from 30 to 120 mg/day	Placebo Treatment n=28 Participants placebo treatment, with capsules matching the duloxetine medication
Global Assessment of Functioning Scale (GAF)	62.6 points on rating scale Standard Deviation 5.8	58.3 points on rating scale Standard Deviation 7.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

To use resting-state fMRI to study the effects of antidepressant therapy on default mode network (DMN) connectivity density.

Outcome measures

Outcome measures
Measure	Duloxetine (Cymbalta) n=15 Participants Duloxetine medication, ranging from 30 to 120 mg/day	Placebo Treatment n=17 Participants placebo treatment, with capsules matching the duloxetine medication
Resting-state Functional Connectivity Magnetic Resonance Imaging(fMRI)	0.21 percentage of connecting nods Standard Deviation 0.08	0.24 percentage of connecting nods Standard Deviation 0.06

OTHER_PRE_SPECIFIED outcome

Timeframe: Follow up

To use resting-state fMRI to study the effects of antidepressant therapy on default mode network (DMN) connectivity density.

Outcome measures

Outcome measures
Measure	Duloxetine (Cymbalta) n=15 Participants Duloxetine medication, ranging from 30 to 120 mg/day	Placebo Treatment n=17 Participants placebo treatment, with capsules matching the duloxetine medication
Resting-state Functional Connectivity Magnetic Resonance Imaging(fMRI)	0.16 percentage of connecting nods Standard Deviation 0.06	0.19 percentage of connecting nods Standard Deviation 0.08

Adverse Events

Duloxetine (Cymbalta)

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Placebo Treatment

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Duloxetine (Cymbalta) n=29 participants at risk；n=33 participants at risk Duloxetine medication, ranging from 30 to 120 mg/day	Placebo Treatment n=28 participants at risk；n=32 participants at risk placebo treatment: treatment with placebo capsules that match active medication capsules
Gastrointestinal disorders GI upset	24.1% 7/29 • Number of events 7 • patients were treated in study for 22 weeks, including 10 weeks double blind medication vs placebo and 12 weeks open label treatment. All started participants were assessed for Serious Adverse Events, while only completed participants were assessed for Other Adverse Events.	32.1% 9/28 • Number of events 9 • patients were treated in study for 22 weeks, including 10 weeks double blind medication vs placebo and 12 weeks open label treatment. All started participants were assessed for Serious Adverse Events, while only completed participants were assessed for Other Adverse Events.
General disorders Fatigue	31.0% 9/29 • Number of events 9 • patients were treated in study for 22 weeks, including 10 weeks double blind medication vs placebo and 12 weeks open label treatment. All started participants were assessed for Serious Adverse Events, while only completed participants were assessed for Other Adverse Events.	28.6% 8/28 • Number of events 8 • patients were treated in study for 22 weeks, including 10 weeks double blind medication vs placebo and 12 weeks open label treatment. All started participants were assessed for Serious Adverse Events, while only completed participants were assessed for Other Adverse Events.
General disorders Nausea	20.7% 6/29 • Number of events 6 • patients were treated in study for 22 weeks, including 10 weeks double blind medication vs placebo and 12 weeks open label treatment. All started participants were assessed for Serious Adverse Events, while only completed participants were assessed for Other Adverse Events.	17.9% 5/28 • Number of events 5 • patients were treated in study for 22 weeks, including 10 weeks double blind medication vs placebo and 12 weeks open label treatment. All started participants were assessed for Serious Adverse Events, while only completed participants were assessed for Other Adverse Events.
General disorders Dizziness	6.9% 2/29 • Number of events 2 • patients were treated in study for 22 weeks, including 10 weeks double blind medication vs placebo and 12 weeks open label treatment. All started participants were assessed for Serious Adverse Events, while only completed participants were assessed for Other Adverse Events.	14.3% 4/28 • Number of events 4 • patients were treated in study for 22 weeks, including 10 weeks double blind medication vs placebo and 12 weeks open label treatment. All started participants were assessed for Serious Adverse Events, while only completed participants were assessed for Other Adverse Events.
General disorders Decreased Sleep	20.7% 6/29 • Number of events 6 • patients were treated in study for 22 weeks, including 10 weeks double blind medication vs placebo and 12 weeks open label treatment. All started participants were assessed for Serious Adverse Events, while only completed participants were assessed for Other Adverse Events.	14.3% 4/28 • Number of events 4 • patients were treated in study for 22 weeks, including 10 weeks double blind medication vs placebo and 12 weeks open label treatment. All started participants were assessed for Serious Adverse Events, while only completed participants were assessed for Other Adverse Events.
General disorders Decreased Appetite	27.6% 8/29 • Number of events 8 • patients were treated in study for 22 weeks, including 10 weeks double blind medication vs placebo and 12 weeks open label treatment. All started participants were assessed for Serious Adverse Events, while only completed participants were assessed for Other Adverse Events.	14.3% 4/28 • Number of events 4 • patients were treated in study for 22 weeks, including 10 weeks double blind medication vs placebo and 12 weeks open label treatment. All started participants were assessed for Serious Adverse Events, while only completed participants were assessed for Other Adverse Events.
General disorders Vivid Dream	24.1% 7/29 • Number of events 7 • patients were treated in study for 22 weeks, including 10 weeks double blind medication vs placebo and 12 weeks open label treatment. All started participants were assessed for Serious Adverse Events, while only completed participants were assessed for Other Adverse Events.	3.6% 1/28 • Number of events 1 • patients were treated in study for 22 weeks, including 10 weeks double blind medication vs placebo and 12 weeks open label treatment. All started participants were assessed for Serious Adverse Events, while only completed participants were assessed for Other Adverse Events.

Additional Information

David Hellerstein MD

NY State Psychiatric Institute

Phone: 6467748000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60