Trial Outcomes & Findings for The ISLAND Study: InSuLa Assessed Needs for Depression (NCT NCT02137369)
NCT ID: NCT02137369
Last Updated: 2020-11-05
Results Overview
Remission from major depressive episode as assessed by 17-item Hamilton Depression Rating Scale.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
77 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-11-05
Participant Flow
77 were consented, 60 started treatments
Participant milestones
| Measure |
SSRI
Escitalopram, pill form, 20mg-40mg, daily, for 12 weeks OR Sertraline, pill form, 50-150 mg, daily for 12 weeks.
|
Cognitive Behavioral Therapy
Cognitive Behavioral Therapy (CBT)
Cognitive Behavioral Therapy: Cognitive Behavioral Therapy, standardized, 16 1-hour sessions over 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
11
|
|
Overall Study
COMPLETED
|
41
|
9
|
|
Overall Study
NOT COMPLETED
|
8
|
2
|
Reasons for withdrawal
| Measure |
SSRI
Escitalopram, pill form, 20mg-40mg, daily, for 12 weeks OR Sertraline, pill form, 50-150 mg, daily for 12 weeks.
|
Cognitive Behavioral Therapy
Cognitive Behavioral Therapy (CBT)
Cognitive Behavioral Therapy: Cognitive Behavioral Therapy, standardized, 16 1-hour sessions over 12 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Moved away
|
2
|
0
|
Baseline Characteristics
The ISLAND Study: InSuLa Assessed Needs for Depression
Baseline characteristics by cohort
| Measure |
SSRI
n=49 Participants
Escitalopram, pill form, 20mg-40mg, daily, for 12 weeks OR Sertraline, pill form, 50-150 mg, daily, for 12 weeks
|
Cognitive Behavioral Therapy
n=11 Participants
Cognitive Behavioral Therapy (CBT) CBT will include 16 1-hour standardized sessions provided over 12 weeks.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
11 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
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
|
49 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksRemission from major depressive episode as assessed by 17-item Hamilton Depression Rating Scale.
Outcome measures
| Measure |
SSRI
n=49 Participants
Escitalopram, pill form, 20mg-40mg, daily, for 12 weeks, OR
Sertraline, \[pill form, 50-150 mg, daily for 12 weeks
|
Cognitive Behavioral Therapy
n=11 Participants
Cognitive Behavioral Therapy (CBT) CBT will include 16 1-hour sessions provided over 12 weeks.
Cognitive Behavioral Therapy: Cognitive Behavioral Therapy, standardized, 16 sessions over 12 weeks.
|
|---|---|---|
|
Number of Remission From Major Depressive Episode Events
|
15 number of events
|
4 number of events
|
SECONDARY outcome
Timeframe: 12 weeksResponse Defined as 50% Change in Hamilton Depression Rating Scale-17 Score at 12 Weeks
Outcome measures
| Measure |
SSRI
n=49 Participants
Escitalopram, pill form, 20mg-40mg, daily, for 12 weeks, OR
Sertraline, \[pill form, 50-150 mg, daily for 12 weeks
|
Cognitive Behavioral Therapy
n=11 Participants
Cognitive Behavioral Therapy (CBT) CBT will include 16 1-hour sessions provided over 12 weeks.
Cognitive Behavioral Therapy: Cognitive Behavioral Therapy, standardized, 16 sessions over 12 weeks.
|
|---|---|---|
|
Number of Response to Treatment Events
|
21 number of events
|
5 number of events
|
Adverse Events
SSRI
Serious events: 1 serious events
Other events: 44 other events
Deaths: 0 deaths
Cognitive Behavioral Therapy
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SSRI
n=49 participants at risk
Escitalopram, pill form, 20mg-40mg, daily, for 12 weeks OR Sertraline, pill form, 50-150 mg, daily, for 12 weeks
|
Cognitive Behavioral Therapy
n=11 participants at risk
Cognitive Behavioral Therapy (CBT)
Cognitive Behavioral Therapy: Cognitive Behavioral Therapy, standardized, 16 1-hour sessions over 12 weeks.
|
|---|---|---|
|
Psychiatric disorders
Hospitalization for suicidal ideation
|
2.0%
1/49 • Number of events 1 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
Other adverse events
| Measure |
SSRI
n=49 participants at risk
Escitalopram, pill form, 20mg-40mg, daily, for 12 weeks OR Sertraline, pill form, 50-150 mg, daily, for 12 weeks
|
Cognitive Behavioral Therapy
n=11 participants at risk
Cognitive Behavioral Therapy (CBT)
Cognitive Behavioral Therapy: Cognitive Behavioral Therapy, standardized, 16 1-hour sessions over 12 weeks.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.3%
8/49 • Number of events 9 • 12 weeks
|
9.1%
1/11 • Number of events 1 • 12 weeks
|
|
Surgical and medical procedures
Sedation
|
16.3%
8/49 • Number of events 8 • 12 weeks
|
9.1%
1/11 • Number of events 1 • 12 weeks
|
|
General disorders
Reduced Concentration
|
14.3%
7/49 • Number of events 7 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
General disorders
Fatigue
|
14.3%
7/49 • Number of events 7 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Nervous system disorders
Dizziness
|
12.2%
6/49 • Number of events 6 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Reproductive system and breast disorders
Libido reduced
|
10.2%
5/49 • Number of events 5 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Nervous system disorders
Restlessness
|
8.2%
4/49 • Number of events 4 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Nervous system disorders
Paresthesia
|
8.2%
4/49 • Number of events 4 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
General disorders
Sweating
|
8.2%
4/49 • Number of events 4 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
General disorders
Yawning
|
8.2%
4/49 • Number of events 4 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
3/49 • Number of events 3 • 12 weeks
|
9.1%
1/11 • Number of events 1 • 12 weeks
|
|
Nervous system disorders
Abnormal Dreams
|
6.1%
3/49 • Number of events 3 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
General disorders
Reduced Appetite
|
6.1%
3/49 • Number of events 3 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
6.1%
3/49 • Number of events 3 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Eye disorders
Blurred vision
|
6.1%
3/49 • Number of events 3 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Gastrointestinal disorders
Constipation
|
4.1%
2/49 • Number of events 2 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Cardiac disorders
Palpitations
|
4.1%
2/49 • Number of events 2 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
General disorders
Feeling hot
|
4.1%
2/49 • Number of events 2 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
General disorders
Abdominal pain
|
4.1%
2/49 • Number of events 2 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.1%
2/49 • Number of events 2 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Gastrointestinal disorders
Gastroenteritis
|
4.1%
2/49 • Number of events 2 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Gastrointestinal disorders
Vomiting
|
4.1%
2/49 • Number of events 2 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
General disorders
Dry mouth
|
4.1%
2/49 • Number of events 2 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
2.0%
1/49 • Number of events 1 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Psychiatric disorders
Cognitive slowing
|
2.0%
1/49 • Number of events 1 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
General disorders
Increased Appetite
|
2.0%
1/49 • Number of events 1 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
General disorders
Chest pain
|
2.0%
1/49 • Number of events 1 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
2.0%
1/49 • Number of events 1 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Psychiatric disorders
Myoclonic jerks
|
2.0%
1/49 • Number of events 1 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Psychiatric disorders
Emotional blunting
|
2.0%
1/49 • Number of events 1 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Plantar fascitis
|
2.0%
1/49 • Number of events 1 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Infections and infestations
Fungal infection
|
2.0%
1/49 • Number of events 1 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Reproductive system and breast disorders
Orgasm abnormal
|
2.0%
1/49 • Number of events 1 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Injury, poisoning and procedural complications
Laceration
|
2.0%
1/49 • Number of events 1 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
General disorders
Epistaxis
|
2.0%
1/49 • Number of events 1 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
General disorders
Weight gain
|
2.0%
1/49 • Number of events 1 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
2.0%
1/49 • Number of events 1 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
2.0%
1/49 • Number of events 1 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Psychiatric disorders
Panic Attack
|
2.0%
1/49 • Number of events 1 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Eye disorders
Iritis
|
2.0%
1/49 • Number of events 1 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Infections and infestations
Mouth Sores
|
2.0%
1/49 • Number of events 1 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Reproductive system and breast disorders
Bacterial vaginosis
|
2.0%
1/49 • Number of events 1 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
General disorders
Difficulty swallowing
|
2.0%
1/49 • Number of events 1 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
2.0%
1/49 • Number of events 1 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Psychiatric disorders
Worsening depression
|
2.0%
1/49 • Number of events 1 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Renal and urinary disorders
Renal calculus
|
2.0%
1/49 • Number of events 1 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Jaw tightness
|
2.0%
1/49 • Number of events 1 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Renal and urinary disorders
Increased Urination
|
2.0%
1/49 • Number of events 1 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
General disorders
Headache
|
38.8%
19/49 • Number of events 21 • 12 weeks
|
9.1%
1/11 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
24.5%
12/49 • Number of events 13 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Nervous system disorders
Insomnia
|
18.4%
9/49 • Number of events 10 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Gastrointestinal disorders
Diarea
|
16.3%
8/49 • Number of events 9 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Psychiatric disorders
Anxiety
|
18.4%
9/49 • Number of events 9 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
16.3%
8/49 • Number of events 8 • 12 weeks
|
18.2%
2/11 • Number of events 2 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place