Medication Treatment for Depression in Nursing Home Residents

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT00076622
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 94
• Location: 1
• Duration (Months): 68
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

This study will examine therapeutic and adverse effects of continuing versus discontinuing antidepressant medication in nursing home residents who have had no more than a single episode of depression and who no longer have depressive symptoms.

Condition or Disease	Intervention/Treatment	Phase
Depression	Drug: Antidepressant medication; Drug: No antidepressant medication

Detailed Description

There are approximately 1.6 million nursing home residents in the United States. More than one third of these residents are taking antidepressant medications (ADs). Although ADs are effective, evidence suggests that they can lead to significant adverse events, including an increased risk of falls and bone fractures. Many depressed nursing home residents suffer from an initial episode of late-life depression and do not meet guideline-based recommendations for maintenance treatment. This study will examine the benefits and risks of long-term AD treatment in depressed nursing home residents whose single episode of depression has been in continuous remission for at least six months.

Participants will be randomly assigned to either continue or discontinue AD treatment. Participants will be monitored over a period of one year for recurrence of depression and related symptoms, as well as for the occurrence of falls, fractures, and other adverse events. Medical chart review, self-reported mood symptoms, and depression scales will be used to assess participants.

Study Design

• Study Type: Observational
• Actual Enrollment: 94 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Drug Treatment of Depression in the Nursing Home Aged
• Study Start Date: Nov 1, 2003
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Randomized to drug continuation Participants assigned to continue current antidepressant medication	Drug: Antidepressant medication; Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.
Randomized to drug discontinuation Participants assigned to discontinue current antidepressant medication (no antidepressant medication)	Drug: No antidepressant medication; Participants assigned to discontinue current medication (no antidepressant medication) will be monitored over a period of one year for recurrence of depression and related symptoms.
Participant preference to continue drug Chose to continue antidepressant medication	Drug: Antidepressant medication; Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.
Participant preference to discontinue drug Chose to discontinue antidepressant medication (no antidepressant medication)	Drug: No antidepressant medication; Participants assigned to discontinue current medication (no antidepressant medication) will be monitored over a period of one year for recurrence of depression and related symptoms.

Outcome Measures

Primary Outcome Measures

1. Geriatric Depression Scale (GDS) Score [Measured at Month 12]

   The GDS scale measures presence and severity of depressive symptoms in older adults. Scores range from zero (no depression symptoms) to thirty (severe depression symptoms).

2. Number of Falls Experienced by Participants Over Twelve Months of Surveillance [Measured from Baseline through Month Twelve]

Secondary Outcome Measures

1. Cognitive Function (MMSE) [Measured at Month 12]

   The Mini Mental State Examination (MMSE) measures cognitive function in multiple domains, including memory, orientation, language, and executive function. Scores range from zero (severe cognitive impairment) to thirty (intact cognitive function).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Current use of antidepressant medication

• Have been in remission from first episode of depression for 6 months or longer

• Currently residing in a long term care or assisted living facility

Exclusion Criteria:

• Bedridden

• Severe cognitive impairment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Joel E. Streim, MD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT00076622
• Other Study ID Numbers: R37MH051247; R37MH051247; DSIR AT-GP
• First Posted: Jan 29, 2004
• Last Update Posted: Jan 31, 2018
• Last Verified: Jan 1, 2018

• Keywords provided by University of Pennsylvania: Antidepressant drugs; Nursing Homes
• Additional relevant MeSH terms: Depression; Depressive Disorder; Antidepressive Agents

Study Results

Participant Flow

Arm/Group Title	Randomized to Drug Continuation	Randomized to Drug Discontinuation	Participant Preference to Continue Drug	Participant Preference to Discontinue Drug
Arm/Group Description	Participants assigned to continue current antidepressant medication Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.	Participants assigned to discontinue current antidepressant medication No antidepressant medication: Participants assigned to discontinue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.	Chose to continue antidepressant medication Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.	Chose to stop antidepressant medication No antidepressant medication: Participants assigned to discontinue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.
Period Title: Overall Study
STARTED	23	13	40	18
COMPLETED	23	13	40	18
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Randomized to Drug Continuation	Randomized to Drug Discontinuation	Participant Preference to Continue Drug	Participant Preference to Discontinue Drug	Total
Arm/Group Description	Participants assigned to continue current antidepressant medication Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.	Participants assigned to discontinue current antidepressant medication No antidepressant medication: Participants assigned to discontinue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.	Chose to continue antidepressant medication Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.	Chose to stop antidepressant medication No antidepressant medication: Participants assigned to discontinue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.	Total of all reporting groups
Overall Participants	23	13	40	18	94
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%	0 0%
>=65 years	23 100%	13 100%	40 100%	18 100%	94 100%
Sex: Female, Male (Count of Participants)
Female	18 78.3%	10 76.9%	30 75%	16 88.9%	74 78.7%
Male	5 21.7%	3 23.1%	10 25%	2 11.1%	20 21.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	1 2.5%	0 0%	1 1.1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	6 26.1%	0 0%	5 12.5%	2 11.1%	13 13.8%
White	17 73.9%	13 100%	34 85%	16 88.9%	80 85.1%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	23 100%	13 100%	40 100%	18 100%	94 100%
Geriatric Depression Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4.3 (3.1)	4.6 (2.9)	4.5 (2.4)	2.6 (1.5)	4.3 (2.7)
Cognitive function (MMSE) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	23.1 (4.4)	24.9 (4.0)	24.4 (3.7)	24.3 (4.5)	24.1 (4.1)

Outcome Measures

1. Primary Outcome

Title	Geriatric Depression Scale (GDS) Score
Description	The GDS scale measures presence and severity of depressive symptoms in older adults. Scores range from zero (no depression symptoms) to thirty (severe depression symptoms).
Time Frame	Measured at Month 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Randomized Arm-continue	Randomized Arm-discontinue	Non Randomized/Preference Arm-continue	Non-Randomized Preference-discontinue
Arm/Group Description	Participants who agreed to be randomized were assigned to the continuation antidepressant	Those who were randomized to discontinue anti depressants	Those individuals who refused randomization were offered participation based on their preference (or a proxy/family member's preference, or their doctor's preference) to continue and were assigned to those groups based on their non-random choice.	Those individuals who refused randomization were offered participation based on their preference (or a proxy/family member's preference, or their doctor's preference) to discontinue, and were assigned to those groups based on their non-random choice.
Measure Participants	23	13	40	18
Mean (Standard Deviation) [units on a scale]	5.11 (0.86)	5.03 (1.15)	4.59 (0.49)	4.64 (0.75)

2. Primary Outcome

Title	Number of Falls Experienced by Participants Over Twelve Months of Surveillance
Time Frame	Measured from Baseline through Month Twelve

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Randomized Arm-continue	Randomized Arm-discontinue	Non Randomized/Preference Arm-continue	Non-Randomized Preference-discontinue
Arm/Group Description	Participants who agreed to be randomized were assigned to the continuation antidepressant	Those who were randomized to discontinue anti depressants	Those individuals who refused randomization were offered participation based on their preference (or a proxy/family member's preference, or their doctor's preference) to continue and were assigned to those groups based on their non-random choice.	Those individuals who refused randomization were offered participation based on their preference (or a proxy/family member's preference, or their doctor's preference) to discontinue, and were assigned to those groups based on their non-random choice.
Measure Participants	23	13	40	18
Number [number of falls]	12	9	26	10

3. Secondary Outcome

Title	Cognitive Function (MMSE)
Description	The Mini Mental State Examination (MMSE) measures cognitive function in multiple domains, including memory, orientation, language, and executive function. Scores range from zero (severe cognitive impairment) to thirty (intact cognitive function).
Time Frame	Measured at Month 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Randomized to Drug Continuation	Randomized to Drug Discontinuation	Participant Preference to Continue Drug	Participant Preference to Discontinue Drug
Arm/Group Description	Participants assigned to continue current antidepressant medication Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.	Participants assigned to discontinue current antidepressant medication (no antidepressant medication) No antidepressant medication: Participants assigned to discontinue current medication (no antidepressant medication) will be monitored over a period of one year for recurrence of depression and related symptoms.	Chose to continue antidepressant medication Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.	Chose to discontinue antidepressant medication (no antidepressant medication) No antidepressant medication: Participants assigned to discontinue current medication (no antidepressant medication) will be monitored over a period of one year for recurrence of depression and related symptoms.
Measure Participants	23	13	40	18
Mean (Standard Deviation) [units on a scale]	23.1 (4.4)	24.9 (4.0)	24.4 (3.7)	24.3 (4.5)

Adverse Events

Time Frame	12 months
Arm/Group Title	Randomized to Drug Continuation		Randomized to Discontinuation		Participation Based Upon Preference (Continue)		Participation Based Upon Preference (Discontinue)
Arm/Group Description	Participants assigned to continue current antidepressant medication Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.		Participants assigned to discontinue current antidepressant medication No antidepressant medication: Participants assigned to discontinue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.		Chose to continue antidepressant medication Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.		Chose to stop antidepressant medication No antidepressant medication: Participants assigned to discontinue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.
All Cause Mortality
	Randomized to Drug Continuation		Randomized to Discontinuation		Participation Based Upon Preference (Continue)		Participation Based Upon Preference (Discontinue)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/23 (4.3%)		1/13 (7.7%)		1/40 (2.5%)		1/18 (5.6%)
Serious Adverse Events
	Randomized to Drug Continuation		Randomized to Discontinuation		Participation Based Upon Preference (Continue)		Participation Based Upon Preference (Discontinue)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/23 (34.8%)		4/13 (30.8%)		14/40 (35%)		5/18 (27.8%)
Cardiac disorders
bradycardia	1/23 (4.3%)	1	0/13 (0%)	0	0/40 (0%)	0	0/18 (0%)	0
myocardial infarction	1/23 (4.3%)	1	0/13 (0%)	0	0/40 (0%)	0	0/18 (0%)	0
congestive heart failure	0/23 (0%)	0	0/13 (0%)	0	0/40 (0%)	0	1/18 (5.6%)	1
Endocrine disorders
hypoglycemia	0/23 (0%)	0	0/13 (0%)	0	1/40 (2.5%)	1	0/18 (0%)	0
Gastrointestinal disorders
tarry stool	0/23 (0%)	0	0/13 (0%)	0	1/40 (2.5%)	1	0/18 (0%)	0
General disorders
hospitalization	1/23 (4.3%)	1	0/13 (0%)	0	0/40 (0%)	0	0/18 (0%)	0
unstable angina with aspiration pneumonia	1/23 (4.3%)	1	0/13 (0%)	0	3/40 (7.5%)	3	2/18 (11.1%)	2
syncope	0/23 (0%)	0	3/13 (23.1%)	3	1/40 (2.5%)	2	0/18 (0%)	0
Immune system disorders
allergic reaction	1/23 (4.3%)	1	0/13 (0%)	0	0/40 (0%)	0	0/18 (0%)	0
Infections and infestations
bronchitis	0/23 (0%)	0	1/13 (7.7%)	1	1/40 (2.5%)	1	0/18 (0%)	0
cellulitis	0/23 (0%)	0	0/13 (0%)	0	1/40 (2.5%)	1	0/18 (0%)	0
urinary tract infection	0/23 (0%)	0	0/13 (0%)	0	0/40 (0%)	0	1/18 (5.6%)	1
Injury, poisoning and procedural complications
polytrauma from motor vehicle accident	1/23 (4.3%)	1	0/13 (0%)	0	0/40 (0%)	0	0/18 (0%)	0
fall	0/23 (0%)	0	1/13 (7.7%)	1	1/40 (2.5%)	1	0/18 (0%)	0
humerus fracture	0/23 (0%)	0	0/13 (0%)	0	1/40 (2.5%)	1	0/18 (0%)	0
hip fracture	0/23 (0%)	0	0/13 (0%)	0	2/40 (5%)	2	0/18 (0%)	0
Metabolism and nutrition disorders
dehydration	1/23 (4.3%)	1	0/13 (0%)	0	1/40 (2.5%)	1	0/18 (0%)	0
toxic metabolic encephalopathy	0/23 (0%)	0	0/13 (0%)	0	0/40 (0%)	0	1/18 (5.6%)	1
weight loss	0/23 (0%)	0	0/13 (0%)	0	0/40 (0%)	0	1/18 (5.6%)	1
Musculoskeletal and connective tissue disorders
hip dislocation	0/23 (0%)	0	0/13 (0%)	0	1/40 (2.5%)	1	0/18 (0%)	0
Nervous system disorders
transient ischemic attack	0/23 (0%)	0	0/13 (0%)	0	1/40 (2.5%)	1	0/18 (0%)	0
Renal and urinary disorders
small bowel obstruction	1/23 (4.3%)	1	0/13 (0%)	0	0/40 (0%)	0	0/18 (0%)	0
Reproductive system and breast disorders
breast cancer	0/23 (0%)	0	1/13 (7.7%)	1	0/40 (0%)	0	0/18 (0%)	0
Vascular disorders
deep vein thrombosis	0/23 (0%)	0	0/13 (0%)	0	1/40 (2.5%)	2	0/18 (0%)	0
Other (Not Including Serious) Adverse Events
	Randomized to Drug Continuation		Randomized to Discontinuation		Participation Based Upon Preference (Continue)		Participation Based Upon Preference (Discontinue)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/23 (91.3%)		12/13 (92.3%)		33/40 (82.5%)		17/18 (94.4%)
Cardiac disorders
congestive heart failure	0/23 (0%)	0	0/13 (0%)	0	2/40 (5%)	2	0/18 (0%)	0
Eye disorders
ophthalmic infection	0/23 (0%)	0	0/13 (0%)	0	0/40 (0%)	0	1/18 (5.6%)	1
Gastrointestinal disorders
diarrhea	4/23 (17.4%)	5	1/13 (7.7%)	1	0/40 (0%)	0	0/18 (0%)	0
vomiting /nausea	3/23 (13%)	3	2/13 (15.4%)	2	2/40 (5%)	2	3/18 (16.7%)	4
constipation	0/23 (0%)	0	0/13 (0%)	0	2/40 (5%)	2	0/18 (0%)	0
duodenal ulcer	0/23 (0%)	0	0/13 (0%)	0	0/40 (0%)	0	1/18 (5.6%)	1
dysphagia	0/23 (0%)	0	1/13 (7.7%)	1	0/40 (0%)	0	0/18 (0%)	0
gastrointestinal bleeding	0/23 (0%)	0	1/13 (7.7%)	1	0/40 (0%)	0	1/18 (5.6%)	1
hemorrhoids	0/23 (0%)	0	1/13 (7.7%)	1	0/40 (0%)	0	1/18 (5.6%)	1
General disorders
fall	11/23 (47.8%)	17	7/13 (53.8%)	20	22/40 (55%)	78	11/18 (61.1%)	19
anemia	0/23 (0%)	0	1/13 (7.7%)	1	1/40 (2.5%)	1	0/18 (0%)	0
dizziness	0/23 (0%)	0	0/13 (0%)	0	1/40 (2.5%)	1	3/18 (16.7%)	4
epistaxis	0/23 (0%)	0	0/13 (0%)	0	0/40 (0%)	0	1/18 (5.6%)	1
leg edema	2/23 (8.7%)	2	0/13 (0%)	0	0/40 (0%)	0	1/18 (5.6%)	1
Infections and infestations
upper respiratory infection	5/23 (21.7%)	6	7/13 (53.8%)	10	6/40 (15%)	8	5/18 (27.8%)	7
urinary tract infection	3/23 (13%)	4	5/13 (38.5%)	5	10/40 (25%)	18	2/18 (11.1%)	5
cellulitis	0/23 (0%)	0	0/13 (0%)	0	1/40 (2.5%)	1	1/18 (5.6%)	1
clostridium difficile infection	0/23 (0%)	0	0/13 (0%)	0	0/40 (0%)	0	1/18 (5.6%)	1
dental infection	0/23 (0%)	0	1/13 (7.7%)	1	1/40 (2.5%)	1	0/18 (0%)	0
herpes simplex	0/23 (0%)	0	1/13 (7.7%)	1	0/40 (0%)	0	0/18 (0%)	0
herpes zoster	0/23 (0%)	0	0/13 (0%)	0	0/40 (0%)	0	1/18 (5.6%)	1
hepatitis C	0/23 (0%)	0	0/13 (0%)	0	0/40 (0%)	0	1/18 (5.6%)	1
pneumonia	0/23 (0%)	0	2/13 (15.4%)	2	3/40 (7.5%)	3	0/18 (0%)	0
Injury, poisoning and procedural complications
tooth fracture	0/23 (0%)	0	0/13 (0%)	0	0/40 (0%)	0	1/18 (5.6%)	1
Metabolism and nutrition disorders
gout	0/23 (0%)	0	1/13 (7.7%)	1	1/40 (2.5%)	1	0/18 (0%)	0
weight loss	2/23 (8.7%)	2	1/13 (7.7%)	1	2/40 (5%)	2	2/18 (11.1%)	2
Musculoskeletal and connective tissue disorders
osteoarthritis	0/23 (0%)	0	0/13 (0%)	0	0/40 (0%)	0	1/18 (5.6%)	1
rotator cuff syndrome	0/23 (0%)	0	0/13 (0%)	0	0/40 (0%)	0	1/18 (5.6%)	1
vertebral compression fracture	1/23 (4.3%)	1	1/13 (7.7%)	1	0/40 (0%)	0	0/18 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
colonic polyps	1/23 (4.3%)	1	0/13 (0%)	0	1/40 (2.5%)	1	1/18 (5.6%)	1
skin cancer	0/23 (0%)	0	0/13 (0%)	0	2/40 (5%)	2	0/18 (0%)	0
Nervous system disorders
headache	1/23 (4.3%)	1	0/13 (0%)	0	0/40 (0%)	0	2/18 (11.1%)	2
neuropathic pain	0/23 (0%)	0	0/13 (0%)	0	0/40 (0%)	0	1/18 (5.6%)	1
Psychiatric disorders
depression	0/23 (0%)	0	4/13 (30.8%)	5	2/40 (5%)	2	0/18 (0%)	0
mental status change	0/23 (0%)	0	0/13 (0%)	0	1/40 (2.5%)	1	1/18 (5.6%)	1
Renal and urinary disorders
flank pain	0/23 (0%)	0	0/13 (0%)	0	0/40 (0%)	0	1/18 (5.6%)	1
Respiratory, thoracic and mediastinal disorders
bronchitis	2/23 (8.7%)	2	1/13 (7.7%)	1	0/40 (0%)	0	1/18 (5.6%)	1
chronic obstructive pulmonary disease	0/23 (0%)	0	0/13 (0%)	0	2/40 (5%)	2	0/18 (0%)	0
cough	0/23 (0%)	0	0/13 (0%)	0	1/40 (2.5%)	1	1/18 (5.6%)	1
wheezing	0/23 (0%)	0	1/13 (7.7%)	1	0/40 (0%)	0	0/18 (0%)	0
Skin and subcutaneous tissue disorders
skin tear	2/23 (8.7%)	2	1/13 (7.7%)	1	2/40 (5%)	2	3/18 (16.7%)	4
abrasion	0/23 (0%)	0	0/13 (0%)	0	0/40 (0%)	0	1/18 (5.6%)	1
abscess	0/23 (0%)	0	0/13 (0%)	0	0/40 (0%)	0	1/18 (5.6%)	1
decubitus ulcer	1/23 (4.3%)	1	2/13 (15.4%)	2	1/40 (2.5%)	1	1/18 (5.6%)	1
dermatitis	0/23 (0%)	0	1/13 (7.7%)	1	0/40 (0%)	0	1/18 (5.6%)	1
skin rash	3/23 (13%)	3	0/13 (0%)	0	3/40 (7.5%)	3	2/18 (11.1%)	2
skin blister	0/23 (0%)	0	0/13 (0%)	0	1/40 (2.5%)	1	1/18 (5.6%)	1
Vascular disorders
orthostatic hypotension	2/23 (8.7%)	2	1/13 (7.7%)	1	0/40 (0%)	0	0/18 (0%)	0
transient ischemic attack	0/23 (0%)	0	1/13 (7.7%)	1	1/40 (2.5%)	1	0/18 (0%)	0

Limitations/Caveats

Based on an a priori sample size calculation of 160 subjects needed, it is likely that the final sample (N=94) was insufficient to detect a significant difference on the primary outcome measures in the intent-to-treat analyses.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.