Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effectiveness of rTMS in Depressed VA Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01191333
Recruitment Status : Completed
First Posted : August 30, 2010
Results First Posted : February 7, 2018
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Device: rTMS
Device: Sham Device
Enrollment 164
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active rTMS Sham rTMS
Hide Arm/Group Description

Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.

rTMS: Repetitive Transcranial Magnetic Stimulation

Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.

Sham Device: Placebo Device that simulates active rTMS treatment

Period Title: Overall Study
Started 81 83
Completed 60 65
Not Completed 21 18
Arm/Group Title Active rTMS Sham rTMS Total
Hide Arm/Group Description

Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.

rTMS: Repetitive Transcranial Magnetic Stimulation

Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.

Sham Device: Placebo Device that simulates active rTMS treatment

Total of all reporting groups
Overall Number of Baseline Participants 81 83 164
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 81 participants 83 participants 164 participants
55.6  (12.2) 54.8  (12.6) 55.2  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 83 participants 164 participants
Female
14
  17.3%
18
  21.7%
32
  19.5%
Male
67
  82.7%
65
  78.3%
132
  80.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 83 participants 164 participants
American Indian or Alaska Native
2
   2.5%
0
   0.0%
2
   1.2%
Asian
1
   1.2%
3
   3.6%
4
   2.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
12
  14.8%
14
  16.9%
26
  15.9%
White
63
  77.8%
63
  75.9%
126
  76.8%
More than one race
3
   3.7%
2
   2.4%
5
   3.0%
Unknown or Not Reported
0
   0.0%
1
   1.2%
1
   0.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 81 participants 83 participants 164 participants
81
 100.0%
83
 100.0%
164
 100.0%
Beck Scale for Suicide Ideation (BSI)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 77 participants 82 participants 159 participants
3.7  (6.0) 5.6  (6.7) 4.7  (6.5)
[1]
Measure Description: This self-report measure consists of 21 items with overall score range from 0 - 38, with the last two items not counted in scoring. A high score represents a worse outcome.
[2]
Measure Analysis Population Description: Missing values
Beck Depression Inventory (BDI)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 78 participants 77 participants 155 participants
22.6  (10.3) 26.5  (10.0) 24.5  (10.3)
[1]
Measure Description: This measure is a 21-item self-report test presented in a multiple choice format which measures presence and extent of depression with overall score range from 0 - 63. A higher score represents a worse outcome.
[2]
Measure Analysis Population Description: Missing values
VR-36 Mental Component Summary (MCS)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 81 participants 82 participants 163 participants
27.2  (11.6) 25.1  (10.0) 26.2  (10.8)
[1]
Measure Description: Standardized scoring ranging from 0-100. A higher score represents a better outcome
[2]
Measure Analysis Population Description: Missing value
VR-36 Physical Component Summary (PCS)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 81 participants 82 participants 163 participants
42.4  (11.5) 40.2  (10.0) 41.3  (10.8)
[1]
Measure Description: Standardized scoring ranging from 0-100. A higher score represents a better outcome
[2]
Measure Analysis Population Description: Missing value
Montgomery Asberg Depression Rating Scale (MADRS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 81 participants 83 participants 164 participants
24.7  (7.6) 26.2  (6.9) 25.5  (7.3)
[1]
Measure Description: As another measure of depression, the Montgomery-Asberg Depression Rating Scale (MADRS) has been used with increasing frequency in recent years to measure outcome in antidepressant efficacy trials. It offers an alternative view of depressive illness, and may be sensitive to depressive symptoms that are not easily captured in the context of the HRSD, such as hypersomnia, increased appetite, and concentration/indecision. The MADRS is a 10-item clinician rating of depressive symptoms. Each item is scored on a 7-point scale (0 to 6) (range 0–60).
1.Primary Outcome
Title The Proportion of Participants Achieving Remission From Depression as Assessed by Hamilton Rating Scale for Depression
Hide Description The primary outcome is a proportion of participants achieving remission from depression based on the HRSD24 less than or equal to 10 at the end of the acute treatment phase. 24 item Instrument with overall score range from 0 - 76. High values represent a worse outcome.
Time Frame End of acute treatment 4-6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Active rTMS Sham rTMS
Hide Arm/Group Description:

Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.

rTMS: Repetitive Transcranial Magnetic Stimulation

Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.

Sham Device: Placebo Device that simulates active rTMS treatment

Overall Number of Participants Analyzed 81 83
Measure Type: Count of Participants
Unit of Measure: Participants
33
  40.7%
31
  37.3%
2.Secondary Outcome
Title Mean Suicidal Ideation Score as Assessed by Beck Scale for Suicide Ideation (BSS)
Hide Description To help clinicians screen psychiatric patients for suicidal ideation, the Beck Scale for Suicide Ideation was developed, and is herein referred to as the BSS. This self-report measure consists of 21 items with overall score range from 0 - 38, with the last two items not counted in scoring. A high score represents a worse outcome.
Time Frame End of acute treatment 4-6 weeks, then end of F/U 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT minus participants with missing values
Arm/Group Title Active rTMS Sham rTMS
Hide Arm/Group Description:

Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.

rTMS: Repetitive Transcranial Magnetic Stimulation

Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.

Sham Device: Placebo Device that simulates active rTMS treatment

Overall Number of Participants Analyzed 67 72
Mean (Standard Deviation)
Unit of Measure: units on a scale
End of Acute Treatment 2.0  (4.6) 2.7  (4.9)
End of F/U 1.5  (4.2) 2.5  (4.9)
3.Secondary Outcome
Title Mean Depression Score as Assessed by Beck Depression Inventory (BDI)
Hide Description This measure is a 21-item self-report test presented in a multiple choice format which measures presence and extent of depression with overall score range from 0 - 63. A higher score represents a worse outcome. Each of the 21 items addresses a specific symptom or attitude that pertains to depressed patients, and which are consistent with descriptions of the depression within the peer-reviewed literature. While generally deemed less reliable than scales score by a trained rater (for example, the HRSD), the Beck scale is easy to administer, and provides convenient means by which patients can effectively communicate their own perception of their mood state.
Time Frame Baseline - end of acute treatment 4-6 weeks, then end of F/U 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT minus participants with missing values
Arm/Group Title Active rTMS Sham rTMS
Hide Arm/Group Description:

Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.

rTMS: Repetitive Transcranial Magnetic Stimulation

Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.

Sham Device: Placebo Device that simulates active rTMS treatment

Overall Number of Participants Analyzed 66 72
Mean (Standard Deviation)
Unit of Measure: units on a scale
End of Acute Treatment 14.2  (10.9) 13.0  (9.5)
End of F/U 9.0  (8.3) 12.8  (10.8)
4.Secondary Outcome
Title Mean Mental Component Score as Assessed by VR-36 Mental Component Summary (MCS)
Hide Description The VR-36 is a self-administered survey that measures eight dimensions of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these eight health domains, and two summary measures of physical and mental health: the Physical Component Summary (PCS) and Mental Component Summary (MCS). MCS is analyzed in this section. Standardized scoring ranging from 0-100. A higher score represents a better outcome.
Time Frame End of acute treatment 4-6 weeks, then end of F/U 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT minus participants with missing values
Arm/Group Title Active rTMS Sham rTMS
Hide Arm/Group Description:

Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.

rTMS: Repetitive Transcranial Magnetic Stimulation

Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.

Sham Device: Placebo Device that simulates active rTMS treatment

Overall Number of Participants Analyzed 68 73
Mean (Standard Deviation)
Unit of Measure: units on a scale
End of Acute Treatment 35.1  (14.3) 36.0  (14.7)
End of F/U 34.5  (12.8) 34.8  (13.4)
5.Secondary Outcome
Title Mean Physical Component Score as Assessed by VR-36 Physical Component Summary (PCS)
Hide Description The VR-36 is a self-administered survey that measures eight dimensions of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these eight health domains, and two summary measures of physical and mental health: the Physical Component Summary (PCS) and Mental Component Summary (MCS). PCS is analyzed in this section. Standardized scoring ranging from 0-100. A higher score represents a better outcome.
Time Frame End of acute treatment 4-6 weeks, then end of F/U 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT minus participants with missing values
Arm/Group Title Active rTMS Sham rTMS
Hide Arm/Group Description:

Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.

rTMS: Repetitive Transcranial Magnetic Stimulation

Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.

Sham Device: Placebo Device that simulates active rTMS treatment

Overall Number of Participants Analyzed 68 73
Mean (Standard Deviation)
Unit of Measure: units on a scale
End of Acute Treatment 41.9  (10.9) 41.2  (11.9)
End of F/U 42.8  (10.8) 40.1  (12.3)
6.Secondary Outcome
Title Mean Depression Score as Assessed by the Montgomery Asberg Depression Rating Scale (MADRS)
Hide Description As another measure of depression, the Montgomery-Asberg Depression Rating Scale (MADRS) has been used with increasing frequency in recent years to measure outcome in antidepressant efficacy trials. It offers an alternative view of depressive illness, and may be sensitive to depressive symptoms that are not easily captured in the context of the HRSD, such as hypersomnia, increased appetite, and concentration/indecision. The MADRS is a 10-item clinician rating of depressive symptoms. Each item is scored on a 7-point scale (0 to 6) (range 0–60). A high score represents a worse outcome.
Time Frame End of acute treatment 4-6 weeks, then end of F/U 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT minus participants with missing values
Arm/Group Title Active rTMS Sham rTMS
Hide Arm/Group Description:

Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.

rTMS: Repetitive Transcranial Magnetic Stimulation

Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.

Sham Device: Placebo Device that simulates active rTMS treatment

Overall Number of Participants Analyzed 70 74
Mean (Standard Deviation)
Unit of Measure: units on a scale
End of Acute Treatment 14.3  (11.1) 13.1  (10.5)
End of F/U 13.7  (10.2) 15.0  (9.7)
Time Frame From informed consent until termination. 7-8 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active rTMS Sham rTMS
Hide Arm/Group Description

Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.

rTMS: Repetitive Transcranial Magnetic Stimulation

Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.

Sham Device: Placebo Device that simulates active rTMS treatment

All-Cause Mortality
Active rTMS Sham rTMS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/81 (0.00%)      0/83 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Active rTMS Sham rTMS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/81 (27.16%)      18/83 (21.69%)    
Cardiac disorders     
Arrhythmia  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Coronary artery disease  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Ear and labyrinth disorders     
Hypoacusis  1  2/81 (2.47%)  2 2/83 (2.41%)  2
Gastrointestinal disorders     
Pancreatitis  1  1/81 (1.23%)  2 0/83 (0.00%)  0
General disorders     
Chest discomfort  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Chest pain  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Drug withdrawal syndrome  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Hernia  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Hepatobiliary disorders     
Gallbladder disorder  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Immune system disorders     
Allergy to arthropod sting  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Infections and infestations     
Gastroenteritis viral  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Orchitis  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Staphylococcal infection  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Viral infection  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Injury, poisoning and procedural complications     
Alcohol poisoning  1  2/81 (2.47%)  2 0/83 (0.00%)  0
Accidental overdose  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Fall  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Road traffic accident  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Investigations     
Acoustic stimulation tests abnormal  1  4/81 (4.94%)  4 5/83 (6.02%)  5
Metabolism and nutrition disorders     
Hyperglycaemia  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Clear cell renal cell carcinoma  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Nervous system disorders     
Transient ischaemic attack  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Psychiatric disorders     
Suicidal ideation  1  4/81 (4.94%)  4 4/83 (4.82%)  4
Depression  1  1/81 (1.23%)  1 2/83 (2.41%)  2
Suicide attempt  1  1/81 (1.23%)  1 1/83 (1.20%)  1
Anxiety  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Depressed mood  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Depression suicidal  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Mania  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Obsessive-compulsive disorder  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Persistent depressive disorder  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Post-traumatic stress disorder  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Respiratory, thoracic and mediastinal disorders     
Pleuritic pain  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Pulmonary embolism  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Vascular disorders     
Hypotension  1  1/81 (1.23%)  1 0/83 (0.00%)  0
1
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active rTMS Sham rTMS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   71/81 (87.65%)      69/83 (83.13%)    
Blood and lymphatic system disorders     
Lymphadenopathy  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Cardiac disorders     
Arrhythmia  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Congenital, familial and genetic disorders     
Arnold-Chiari malformation  1  1/81 (1.23%)  3 0/83 (0.00%)  0
Ear and labyrinth disorders     
Hypoacusis  1  1/81 (1.23%)  1 4/83 (4.82%)  4
Tinnitus  1  1/81 (1.23%)  1 2/83 (2.41%)  3
Ear pain  1  1/81 (1.23%)  1 2/83 (2.41%)  2
Vertigo  1  1/81 (1.23%)  1 2/83 (2.41%)  2
Deafness neurosensory  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Endocrine disorders     
Thyroid mass  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Eye disorders     
Vision blurred  1  3/81 (3.70%)  3 0/83 (0.00%)  0
Blindness  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Conjunctivitis allergic  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Diabetic retinopathy  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Episcleritis  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Glaucoma  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Photophobia  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Photopsia  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Visual impairment  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Gastrointestinal disorders     
Toothache  1  3/81 (3.70%)  3 2/83 (2.41%)  2
Abdominal discomfort  1  1/81 (1.23%)  1 3/83 (3.61%)  3
Diarrhoea  1  1/81 (1.23%)  1 2/83 (2.41%)  2
Gastrooesophageal reflux disease  1  1/81 (1.23%)  1 2/83 (2.41%)  2
Abdominal pain  1  0/81 (0.00%)  0 2/83 (2.41%)  2
Constipation  1  2/81 (2.47%)  2 0/83 (0.00%)  0
Dental caries  1  0/81 (0.00%)  0 2/83 (2.41%)  2
Dyspepsia  1  0/81 (0.00%)  0 2/83 (2.41%)  2
Nausea  1  1/81 (1.23%)  1 1/83 (1.20%)  1
Vomiting  1  0/81 (0.00%)  0 2/83 (2.41%)  2
Abdominal distension  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Abdominal hernia  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Anal fistula  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Aphthous ulcer  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Diverticulum intestinal  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Flatulence  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Gastrointestinal disorder  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Gastrointestinal pain  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Inguinal hernia  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Oesophageal achalasia  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Retching  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Umbilical hernia  1  0/81 (0.00%)  0 1/83 (1.20%)  1
General disorders     
Pain  1  3/81 (3.70%)  3 4/83 (4.82%)  4
Adverse drug reaction  1  2/81 (2.47%)  2 2/83 (2.41%)  2
Chest pain  1  3/81 (3.70%)  3 1/83 (1.20%)  1
Fatigue  1  2/81 (2.47%)  2 1/83 (1.20%)  1
Influenza like illness  1  2/81 (2.47%)  2 0/83 (0.00%)  0
Pyrexia  1  1/81 (1.23%)  1 1/83 (1.20%)  1
Drug withdrawal syndrome  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Nodule  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Sensation of blood flow  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Sensation of foreign body  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Swelling  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Ulcer  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Hepatobiliary disorders     
Biliary dyskinesia  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Hepatocellular injury  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Immune system disorders     
Seasonal allergy  1  1/81 (1.23%)  1 2/83 (2.41%)  2
Hypersensitivity  1  1/81 (1.23%)  1 1/83 (1.20%)  1
Infections and infestations     
Nasopharyngitis  1  8/81 (9.88%)  8 8/83 (9.64%)  12
Upper respiratory tract infection  1  4/81 (4.94%)  4 4/83 (4.82%)  5
Gastroenteritis  1  4/81 (4.94%)  5 1/83 (1.20%)  1
Sinusitis  1  1/81 (1.23%)  2 3/83 (3.61%)  3
Influenza  1  1/81 (1.23%)  2 2/83 (2.41%)  2
Bronchitis  1  2/81 (2.47%)  2 1/83 (1.20%)  1
Carbuncle  1  0/81 (0.00%)  0 2/83 (2.41%)  3
Cellulitis  1  1/81 (1.23%)  1 2/83 (2.41%)  2
Tooth abscess  1  2/81 (2.47%)  2 1/83 (1.20%)  1
Urinary tract infection  1  0/81 (0.00%)  0 3/83 (3.61%)  3
Epididymitis  1  1/81 (1.23%)  2 0/83 (0.00%)  0
Pilonidal cyst  1  1/81 (1.23%)  1 1/83 (1.20%)  1
Bacterial infection  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Conjunctivitis  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Folliculitis  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Furuncle  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Hordeolum  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Infection  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Laryngitis  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Oral bacterial infection  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Oral herpes  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Pharyngitis streptococcal  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Pneumonia  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Respiratory tract infection  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Skin infection  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Tooth infection  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Vaginitis gardnerella  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Viral infection  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Viral upper respiratory tract infection  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Injury, poisoning and procedural complications     
Fall  1  3/81 (3.70%)  4 6/83 (7.23%)  6
Animal bite  1  0/81 (0.00%)  0 2/83 (2.41%)  3
Limb injury  1  1/81 (1.23%)  1 2/83 (2.41%)  2
Exposure to toxic agent  1  1/81 (1.23%)  2 0/83 (0.00%)  0
Ligament sprain  1  1/81 (1.23%)  1 1/83 (1.20%)  1
Road traffic accident  1  1/81 (1.23%)  1 1/83 (1.20%)  1
Animal scratch  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Arthropod bite  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Arthropod sting  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Contusion  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Ear canal abrasion  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Fibula fracture  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Foot fracture  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Incorrect dosage administered  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Laceration  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Muscle strain  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Penis injury  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Post-traumatic neck syndrome  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Stoma obstruction  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Tooth injury  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Upper limb fracture  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Wound  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Investigations     
Acoustic stimulation tests abnormal  1  16/81 (19.75%)  18 16/83 (19.28%)  19
Colonoscopy  1  2/81 (2.47%)  2 0/83 (0.00%)  0
Alanine aminotransferase increased  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Blood thyroid stimulating hormone increased  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Ejection fraction decreased  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Hepatic enzyme increased  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Protein total decreased  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Metabolism and nutrition disorders     
Hypoglycaemia  1  1/81 (1.23%)  1 2/83 (2.41%)  2
Dehydration  1  0/81 (0.00%)  0 2/83 (2.41%)  2
Gout  1  2/81 (2.47%)  2 0/83 (0.00%)  0
Diabetes mellitus inadequate control  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Musculoskeletal and connective tissue disorders     
Muscle spasms  1  2/81 (2.47%)  2 4/83 (4.82%)  5
Arthralgia  1  4/81 (4.94%)  4 2/83 (2.41%)  2
Back pain  1  2/81 (2.47%)  2 4/83 (4.82%)  4
Arthritis  1  2/81 (2.47%)  2 1/83 (1.20%)  1
Muscle twitching  1  1/81 (1.23%)  1 2/83 (2.41%)  2
Pain in extremity  1  0/81 (0.00%)  0 3/83 (3.61%)  3
Trigger finger  1  1/81 (1.23%)  1 2/83 (2.41%)  2
Exostosis  1  1/81 (1.23%)  1 1/83 (1.20%)  1
Flank pain  1  1/81 (1.23%)  1 1/83 (1.20%)  1
Musculoskeletal pain  1  2/81 (2.47%)  2 0/83 (0.00%)  0
Rotator cuff syndrome  1  2/81 (2.47%)  2 0/83 (0.00%)  0
Bursitis  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Cervical spinal stenosis  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Chest wall mass  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Intervertebral disc degeneration  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Joint effusion  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Musculoskeletal chest pain  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Myalgia  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Neck pain  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Osteoarthritis  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Rhabdomyolysis  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Spinal osteoarthritis  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Synovial cyst  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Temporomandibular joint syndrome  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant melanoma in situ  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Pituitary tumour benign  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Skin cancer  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Nervous system disorders     
Headache  1  15/81 (18.52%)  25 16/83 (19.28%)  25
Dizziness  1  2/81 (2.47%)  2 3/83 (3.61%)  3
Balance disorder  1  0/81 (0.00%)  0 2/83 (2.41%)  2
Sinus headache  1  1/81 (1.23%)  1 1/83 (1.20%)  1
Ataxia  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Facial paralysis  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Hypoaesthesia  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Loss of consciousness  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Memory impairment  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Migraine  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Mononeuropathy  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Paraesthesia  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Phantom pain  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Radiculopathy  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Sensory disturbance  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Speech disorder  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Syncope  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Tension headache  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Tremor  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Visual field defect  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Psychiatric disorders     
Depression  1  6/81 (7.41%)  7 2/83 (2.41%)  2
Anxiety  1  4/81 (4.94%)  4 2/83 (2.41%)  2
Insomnia  1  3/81 (3.70%)  3 1/83 (1.20%)  1
Agitated depression  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Bipolar disorder  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Confusional state  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Derealisation  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Dissociation  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Flashback  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Mood altered  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Panic attack  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Parasomnia  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Post-traumatic stress disorder  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Suicidal ideation  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Renal and urinary disorders     
Incontinence  1  2/81 (2.47%)  3 0/83 (0.00%)  0
Dysuria  1  1/81 (1.23%)  1 1/83 (1.20%)  1
Urinary retention  1  1/81 (1.23%)  1 1/83 (1.20%)  1
Acute kidney injury  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Nephrolithiasis  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Urinary incontinence  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Urinary tract obstruction  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Reproductive system and breast disorders     
Erectile dysfunction  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/81 (1.23%)  1 1/83 (1.20%)  1
Epistaxis  1  1/81 (1.23%)  1 1/83 (1.20%)  1
Oropharyngeal pain  1  2/81 (2.47%)  2 0/83 (0.00%)  0
Sleep apnoea syndrome  1  2/81 (2.47%)  2 0/83 (0.00%)  0
Chronic obstructive pulmonary disease  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Cough  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Haemoptysis  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Hiccups  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Nasal congestion  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Respiratory tract congestion  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Rhinorrhoea  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Skin and subcutaneous tissue disorders     
Rash  1  1/81 (1.23%)  1 1/83 (1.20%)  1
Urticaria  1  1/81 (1.23%)  2 0/83 (0.00%)  0
Dermatitis contact  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Ecchymosis  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Eczema  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Ingrowing nail  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Pain of skin  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Rash pruritic  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Skin discolouration  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Skin discomfort  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Skin reaction  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Skin ulcer  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Surgical and medical procedures     
Tooth extraction  1  1/81 (1.23%)  1 1/83 (1.20%)  1
Dental care  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Elective procedure  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Papilloma excision  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Shoulder operation  1  1/81 (1.23%)  1 0/83 (0.00%)  0
Vascular disorders     
Deep vein thrombosis  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Hypertension  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Lymphoedema  1  0/81 (0.00%)  0 1/83 (1.20%)  1
Orthostatic hypotension  1  1/81 (1.23%)  1 0/83 (0.00%)  0
1
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Jerome Yesavage, MD
Organization: Director, VISN21 MIRECC, Department of Veterans Affairs
Phone: 650-852-3287
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01191333     History of Changes
Other Study ID Numbers: 556
First Submitted: August 26, 2010
First Posted: August 30, 2010
Results First Submitted: January 10, 2018
Results First Posted: February 7, 2018
Last Update Posted: March 9, 2018