Trial Outcomes & Findings for Melatonin Agonist Effects of Tasimelteon Versus Placebo in Patients With Major Depressive Disorder (NCT NCT01428661)
NCT ID: NCT01428661
Last Updated: 2015-06-19
Results Overview
Hamilton Rating Scale for Depression (HAM-D) assesses the range of symptoms that are most frequently observed in subjects with major depressive disorder (MDD) on a scale from 0 to 52. Higher HAM-D scores indicate more severe levels of depressive symptoms, thus, a negative change from baseline indicates a reduction (or improvement) in depressive symptoms.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
507 participants
Primary outcome timeframe
8 weeks
Results posted on
2015-06-19
Participant Flow
\*Tasi: subject left country (1); Placebo: sponsor request (1), subject moved (1), IMP schedule (1), subject incarcerated (1), withdrawn after receipt of medical records (1), visit schedule (1) \*\*Tasi: surgery (1), visit schedule (3), +UDS (2), IMP schdule (2), prohibited meds (1), withdrew consent (1), sponsor terminated trial (175)
Participant milestones
| Measure |
Tasimelteon
20 mg tasimelteon capsules, PO daily for 8 weeks
|
Placebo
Placebo capsules, PO daily for 8 weeks
|
Open Label Tasimelteon
20 mg capsules, PO daily for 52 weeks
|
|---|---|---|---|
|
Double-Masked Phase
STARTED
|
254
|
253
|
0
|
|
Double-Masked Phase
COMPLETED
|
197
|
204
|
0
|
|
Double-Masked Phase
NOT COMPLETED
|
57
|
49
|
0
|
|
Open Label Extension
STARTED
|
0
|
0
|
339
|
|
Open Label Extension
COMPLETED
|
0
|
0
|
19
|
|
Open Label Extension
NOT COMPLETED
|
0
|
0
|
320
|
Reasons for withdrawal
| Measure |
Tasimelteon
20 mg tasimelteon capsules, PO daily for 8 weeks
|
Placebo
Placebo capsules, PO daily for 8 weeks
|
Open Label Tasimelteon
20 mg capsules, PO daily for 52 weeks
|
|---|---|---|---|
|
Double-Masked Phase
Protocol Violation
|
9
|
4
|
0
|
|
Double-Masked Phase
Adverse Event
|
13
|
4
|
0
|
|
Double-Masked Phase
Lost to Follow-up
|
14
|
14
|
0
|
|
Double-Masked Phase
Withdrawal by Subject
|
18
|
20
|
0
|
|
Double-Masked Phase
Lack of Efficacy
|
2
|
1
|
0
|
|
Double-Masked Phase
*Various
|
1
|
6
|
0
|
|
Open Label Extension
Protocol Violation
|
0
|
0
|
9
|
|
Open Label Extension
Adverse Event
|
0
|
0
|
15
|
|
Open Label Extension
Lost to Follow-up
|
0
|
0
|
38
|
|
Open Label Extension
Withdrawal by Subject
|
0
|
0
|
49
|
|
Open Label Extension
Lack of Efficacy
|
0
|
0
|
24
|
|
Open Label Extension
**Various
|
0
|
0
|
185
|
Baseline Characteristics
Melatonin Agonist Effects of Tasimelteon Versus Placebo in Patients With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Tasimelteon
n=254 Participants
20 mg tasimelteon capsules, PO daily for 8 weeks
|
Placebo
n=253 Participants
Placebo capsules, PO daily for 8 weeks
|
Open Label Tasimelteon
n=339 Participants
20 mg capsules, PO daily for 52 weeks
|
Total
n=846 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
NA years
STANDARD_DEVIATION NA • n=93 Participants
|
NA years
STANDARD_DEVIATION NA • n=4 Participants
|
44.1 years
STANDARD_DEVIATION 12.19 • n=27 Participants
|
44.1 years
STANDARD_DEVIATION 12.19 • n=483 Participants
|
|
Gender
Female
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
222 participants
n=27 Participants
|
222 participants
n=483 Participants
|
|
Gender
Male
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
117 participants
n=27 Participants
|
117 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: The Intent-to-Treat (ITT) Population included any subject randomized into the study that receives a dose of study medication and that has completed at least one post-baseline efficacy measurement while on study medication.
Hamilton Rating Scale for Depression (HAM-D) assesses the range of symptoms that are most frequently observed in subjects with major depressive disorder (MDD) on a scale from 0 to 52. Higher HAM-D scores indicate more severe levels of depressive symptoms, thus, a negative change from baseline indicates a reduction (or improvement) in depressive symptoms.
Outcome measures
| Measure |
Tasimelteon
n=249 Participants
20 mg tasimelteon capsules, PO daily for 8 weeks
|
Placebo
n=243 Participants
Placebo capsules, PO daily for 8 weeks
|
Open Label Tasimelteon
n=339 Participants
20 mg capsules, PO daily for 52 weeks
|
|---|---|---|---|
|
Change From Baseline to Endpoint at Week 8 Using the Total Score of the Hamilton Depression Rating Scale (HAM-D)
|
-8.19 units on a scale
Standard Error 0.45
|
-7.83 units on a scale
Standard Error 0.45
|
-13.6 units on a scale
Standard Error 0.34
|
Adverse Events
Tasimelteon
Serious events: 2 serious events
Other events: 38 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 53 other events
Deaths: 0 deaths
Open Label Tasimelteon
Serious events: 6 serious events
Other events: 74 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tasimelteon
n=254 participants at risk
20 mg tasimelteon capsules, PO daily for 8 weeks
|
Placebo
n=252 participants at risk
Placebo capsules, PO daily for 8 weeks
|
Open Label Tasimelteon
n=339 participants at risk
20 mg capsules, PO daily for 52 weeks
|
|---|---|---|---|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/254
One subject randomized to placebo did not take any study drug.
|
0.40%
1/252 • Number of events 1
One subject randomized to placebo did not take any study drug.
|
0.00%
0/339
One subject randomized to placebo did not take any study drug.
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/254
One subject randomized to placebo did not take any study drug.
|
0.40%
1/252 • Number of events 1
One subject randomized to placebo did not take any study drug.
|
0.00%
0/339
One subject randomized to placebo did not take any study drug.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.39%
1/254 • Number of events 1
One subject randomized to placebo did not take any study drug.
|
0.00%
0/252
One subject randomized to placebo did not take any study drug.
|
0.00%
0/339
One subject randomized to placebo did not take any study drug.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/254
One subject randomized to placebo did not take any study drug.
|
0.40%
1/252 • Number of events 1
One subject randomized to placebo did not take any study drug.
|
0.00%
0/339
One subject randomized to placebo did not take any study drug.
|
|
Psychiatric disorders
Suicide Attempt
|
0.39%
1/254 • Number of events 1
One subject randomized to placebo did not take any study drug.
|
0.00%
0/252
One subject randomized to placebo did not take any study drug.
|
0.00%
0/339
One subject randomized to placebo did not take any study drug.
|
|
General disorders
Chest Pain
|
0.00%
0/254
One subject randomized to placebo did not take any study drug.
|
0.00%
0/252
One subject randomized to placebo did not take any study drug.
|
0.59%
2/339 • Number of events 2
One subject randomized to placebo did not take any study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/254
One subject randomized to placebo did not take any study drug.
|
0.00%
0/252
One subject randomized to placebo did not take any study drug.
|
0.29%
1/339 • Number of events 1
One subject randomized to placebo did not take any study drug.
|
|
Infections and infestations
Staphylococcal Infection
|
0.00%
0/254
One subject randomized to placebo did not take any study drug.
|
0.00%
0/252
One subject randomized to placebo did not take any study drug.
|
0.29%
1/339 • Number of events 1
One subject randomized to placebo did not take any study drug.
|
|
Infections and infestations
Hepatitis A
|
0.00%
0/254
One subject randomized to placebo did not take any study drug.
|
0.00%
0/252
One subject randomized to placebo did not take any study drug.
|
0.29%
1/339 • Number of events 1
One subject randomized to placebo did not take any study drug.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/254
One subject randomized to placebo did not take any study drug.
|
0.00%
0/252
One subject randomized to placebo did not take any study drug.
|
0.29%
1/339 • Number of events 1
One subject randomized to placebo did not take any study drug.
|
|
Injury, poisoning and procedural complications
Cervical Vertebral Fracture
|
0.00%
0/254
One subject randomized to placebo did not take any study drug.
|
0.00%
0/252
One subject randomized to placebo did not take any study drug.
|
0.29%
1/339 • Number of events 1
One subject randomized to placebo did not take any study drug.
|
Other adverse events
| Measure |
Tasimelteon
n=254 participants at risk
20 mg tasimelteon capsules, PO daily for 8 weeks
|
Placebo
n=252 participants at risk
Placebo capsules, PO daily for 8 weeks
|
Open Label Tasimelteon
n=339 participants at risk
20 mg capsules, PO daily for 52 weeks
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
15/254 • Number of events 17
One subject randomized to placebo did not take any study drug.
|
5.2%
13/252 • Number of events 15
One subject randomized to placebo did not take any study drug.
|
2.4%
8/339 • Number of events 12
One subject randomized to placebo did not take any study drug.
|
|
Gastrointestinal disorders
Dry Mouth
|
5.5%
14/254 • Number of events 15
One subject randomized to placebo did not take any study drug.
|
4.0%
10/252 • Number of events 10
One subject randomized to placebo did not take any study drug.
|
2.1%
7/339 • Number of events 8
One subject randomized to placebo did not take any study drug.
|
|
Infections and infestations
Upper Respitory Tract Infection
|
3.5%
9/254 • Number of events 9
One subject randomized to placebo did not take any study drug.
|
6.0%
15/252 • Number of events 17
One subject randomized to placebo did not take any study drug.
|
6.5%
22/339 • Number of events 29
One subject randomized to placebo did not take any study drug.
|
|
Nervous system disorders
Headache
|
11.4%
29/254 • Number of events 37
One subject randomized to placebo did not take any study drug.
|
9.5%
24/252 • Number of events 31
One subject randomized to placebo did not take any study drug.
|
10.0%
34/339 • Number of events 47
One subject randomized to placebo did not take any study drug.
|
|
Nervous system disorders
Somnolence
|
6.7%
17/254 • Number of events 19
One subject randomized to placebo did not take any study drug.
|
6.3%
16/252 • Number of events 19
One subject randomized to placebo did not take any study drug.
|
2.9%
10/339 • Number of events 12
One subject randomized to placebo did not take any study drug.
|
|
Infections and infestations
Nasopharyngitis
|
3.5%
9/254 • Number of events 9
One subject randomized to placebo did not take any study drug.
|
4.8%
12/252 • Number of events 12
One subject randomized to placebo did not take any study drug.
|
8.0%
27/339 • Number of events 37
One subject randomized to placebo did not take any study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place