Trial Outcomes & Findings for Electroacupuncture for Major Depression (NCT NCT00071110)
NCT ID: NCT00071110
Last Updated: 2010-01-11
Results Overview
Number of participants whose Hamilton Depression Rating Scale score decreased at least 50% and had a final score less than 10. Minimum score = 0 (best). Maximum score = 52 (worst). The 17 item scale assesses depression symptoms, including Depressed Mood, Feelings of Guilt, Suicidal Ideation, Insomnia, Anxiety, Weight Change, and Insight.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
Change from Baseline to Post-Intervention Endpoint
Results posted on
2010-01-11
Participant Flow
57 Participants were recruited from March 2004 - May 2007 at the UPMC Shadyside Center for Complementary Medicine.
Twenty-nine subjects were randomized to Sham and 28 to Electroacupuncture.
Participant milestones
| Measure |
Electroacupuncture (EA)
Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
|
Sham Acupuncture (SA)
Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
29
|
|
Overall Study
COMPLETED
|
28
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
| Measure |
Electroacupuncture (EA)
Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
|
Sham Acupuncture (SA)
Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
4
|
Baseline Characteristics
Electroacupuncture for Major Depression
Baseline characteristics by cohort
| Measure |
Electroacupuncture (EA)
n=28 Participants
Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
|
Sham Acupuncture (SA)
n=29 Participants
Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0.0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
53.0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4.0 Participants
n=5 Participants
|
|
Age Continuous
|
46.04 years
STANDARD_DEVIATION 11.32 • n=5 Participants
|
48.86 years
STANDARD_DEVIATION 13.12 • n=7 Participants
|
47.47 years
STANDARD_DEVIATION 12.35 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39.0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18.0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
29 participants
n=7 Participants
|
57.0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to Post-Intervention EndpointPopulation: ITT, excluding the first four sham acupuncture subjects, whom the primary acupuncturist erred in treating. Although he correctly used the sham electricity procedure, for these subjects he placed needles in the verum electroacupuncture points of GV-20 and Yin tang.
Number of participants whose Hamilton Depression Rating Scale score decreased at least 50% and had a final score less than 10. Minimum score = 0 (best). Maximum score = 52 (worst). The 17 item scale assesses depression symptoms, including Depressed Mood, Feelings of Guilt, Suicidal Ideation, Insomnia, Anxiety, Weight Change, and Insight.
Outcome measures
| Measure |
Electroacupuncture (EA)
n=28 Participants
Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
|
Sham Acupuncture (SA)
n=25 Participants
Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
|
|---|---|---|
|
Antidepressant Response, Defined as a Hamilton Depression Rating Scale Score Relative Decrease of 50 % or More and a Final Score < 10
|
11 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Mean Change from Baseline to Post-Intervention EndpointPopulation: ITT, excluding the first four sham acupuncture subjects, whom the primary acupuncturist erred in treating. Although he correctly used the sham electricity procedure, for these subjects he placed needles in the verum electroacupuncture points of GV-20 and Yin tang.
Mean change in scores on the Medical Outcomes Survey-Version 1 (MOS-36) PHYSICAL Component Score (MOSPCS) from baseline to post-intervention across treatment group. Minimum Score = 0 (worse); Maximum Score = 100 (better), Normed to be at 50 on a control population. Positive Mean Change scores indicate improvement (an increase in scale score/better).
Outcome measures
| Measure |
Electroacupuncture (EA)
n=28 Participants
Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
|
Sham Acupuncture (SA)
n=25 Participants
Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
|
|---|---|---|
|
Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Physical Component Score (MOSPCS)
|
0.54 Units on a scale
Standard Deviation 6.92
|
-1.65 Units on a scale
Standard Deviation 7.98
|
SECONDARY outcome
Timeframe: Mean Change from Baseline to Post-Intervention EndpointPopulation: ITT, excluding the first four sham acupuncture subjects, whom the primary acupuncturist erred in treating. Although he correctly used the sham electricity procedure, for these subjects he placed needles in the verum electroacupuncture points of GV-20 and Yin tang.
Mean change in scores on the Medical Outcomes Survey-Version 1 (MOS-36) Mental Component Score (MOSMCS) from baseline to post-intervention across treatment group. Minimum Score = 0 (worse); Maximum Score = 100 (better) , Normed to be at 50 on a control population. Positive Mean Change scores indicate improvement (an increase in scale score).
Outcome measures
| Measure |
Electroacupuncture (EA)
n=28 Participants
Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
|
Sham Acupuncture (SA)
n=25 Participants
Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
|
|---|---|---|
|
Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Mental Component Score (MOSMCS)
|
6.23 Units on a scale
Standard Deviation 13.62
|
14.12 Units on a scale
Standard Deviation 17.54
|
SECONDARY outcome
Timeframe: Mean Change from Baseline to Post-Intervention EndpointPopulation: ITT, excluding the first four sham acupuncture subjects, whom the primary acupuncturist erred in treating. Although he correctly used the sham electricity procedure, for these subjects he placed needles in the verum electroacupuncture points of GV-20 and Yin tang.
Mean change in scores on the Medical Outcomes Survey-Version 1 (MOS-36) Bodily Pain Index (MOSBPI) from baseline to post-intervention across treatment group. Minimum Score = 0 (more); Maximum Score = 100 (less). Positive Mean Change scores indicate improvement (an increase in scale score/less pain).
Outcome measures
| Measure |
Electroacupuncture (EA)
n=28 Participants
Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
|
Sham Acupuncture (SA)
n=25 Participants
Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
|
|---|---|---|
|
Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Bodily Pain Index (MOSBPI)
|
-1.04 Units on a scale
Standard Deviation 18.27
|
6.81 Units on a scale
Standard Deviation 19.70
|
Adverse Events
Electroacupuncture (EA)
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Sham Acupuncture (SA)
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Electroacupuncture (EA)
n=28 participants at risk
Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
|
Sham Acupuncture (SA)
n=29 participants at risk
Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
|
|---|---|---|
|
Psychiatric disorders
CONCENTRATION DIFFICULTIES
|
0.00%
0/28 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
10.3%
3/29 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
|
Psychiatric disorders
ASTHENIA / LASSITUDE / INCREASED FATIGUABILITY
|
3.6%
1/28 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
6.9%
2/29 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
|
Psychiatric disorders
SLEEPINESS / SEDATION
|
3.6%
1/28 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
3.4%
1/29 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
|
Psychiatric disorders
FAILING MEMORY
|
3.6%
1/28 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
3.4%
1/29 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
|
Psychiatric disorders
TENSION / INNER UNREST
|
3.6%
1/28 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
10.3%
3/29 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
|
Psychiatric disorders
INCREASED DURATION OF SLEEP:
|
10.7%
3/28 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
13.8%
4/29 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
|
Psychiatric disorders
REDUCED DURATION OF SLEEP:
|
25.0%
7/28 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
24.1%
7/29 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
|
Psychiatric disorders
INCREASED DREAM ACTIVITY
|
32.1%
9/28 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
41.4%
12/29 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
|
Psychiatric disorders
EMOTIONAL INDIFFERENCE
|
7.1%
2/28 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
6.9%
2/29 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
|
Nervous system disorders
TREMOR
|
0.00%
0/28 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
3.4%
1/29 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
|
Nervous system disorders
PARATHESIAS
|
0.00%
0/28 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
3.4%
1/29 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
|
Nervous system disorders
HEADACHE
|
28.6%
8/28 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
13.8%
4/29 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
|
Nervous system disorders
ACCOMMODATION DISTURBANCES
|
0.00%
0/28 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
3.4%
1/29 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
|
Gastrointestinal disorders
NAUSEA / VOMITING
|
25.0%
7/28 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
10.3%
3/29 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
|
Gastrointestinal disorders
DIARRHEA
|
3.6%
1/28 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
3.4%
1/29 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/28 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
10.3%
3/29 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
|
Renal and urinary disorders
MICTURITION DISTURBANCES
|
0.00%
0/28 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
3.4%
1/29 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
|
Nervous system disorders
ORTHOSTATIC DIZZINESS
|
10.7%
3/28 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
10.3%
3/29 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
|
Cardiac disorders
PALPITATIONS / TACHYCARDIA
|
7.1%
2/28 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
3.4%
1/29 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
|
Skin and subcutaneous tissue disorders
INCREASED TENDENCY TO SWEATING
|
10.7%
3/28 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
3.4%
1/29 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
|
Skin and subcutaneous tissue disorders
RASH
|
3.6%
1/28 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
6.9%
2/29 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
3.6%
1/28 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
3.4%
1/29 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
|
Skin and subcutaneous tissue disorders
PHOTOSENSITIVITY
|
7.1%
2/28 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
6.9%
2/29 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
|
Metabolism and nutrition disorders
WEIGHT LOSS
|
0.00%
0/28 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
6.9%
2/29 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
|
Reproductive system and breast disorders
MENORRHAGIA
|
0.00%
0/28 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
3.4%
1/29 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
|
Reproductive system and breast disorders
DIMINISHED SEXUAL DESIRE
|
10.7%
3/28 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
17.2%
5/29 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
|
Reproductive system and breast disorders
ERECTILE DYSFUNCTION
|
0.00%
0/28 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
3.4%
1/29 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
|
Reproductive system and breast disorders
EJACULATORY DYSFUNCTION
|
0.00%
0/28 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
3.4%
1/29 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
|
Reproductive system and breast disorders
ORGASMIC DYSFUNCTION
|
25.0%
7/28 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
13.8%
4/29 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
|
Reproductive system and breast disorders
DRY VAGINA
|
3.6%
1/28 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
0.00%
0/29 • Weekly assessments from Baseline to Post-Intervention endpoint
SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place