Trial Outcomes & Findings for Pipamperone/Citalopram (PNB01) Versus Citalopram (CIT) and Versus Pipamperone (PIP) in Major Depressive Disorder (MDD) (NCT NCT01312922)
NCT ID: NCT01312922
Last Updated: 2022-04-07
Results Overview
Early and Sustained Response (ESR) is defined as a MADRS total score reduction from Baseline of 50% or more and a MADRS total score ≤16 at Week 2, Week 3, Week 4, and Week 6.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
555 participants
Primary outcome timeframe
From (end of) Week 2 visit to (end of) Week 6 visit
Results posted on
2022-04-07
Participant Flow
This was a centrally randomized (stratified), double-blind, multicenter study in up to 40 sites in the U.S. and Canada.
A total of 555 eligible patients were planned and randomized in the study
Participant milestones
| Measure |
PNB01
oral, once daily administration
PNB01 fixed dose combination of pipamperone and citalopram: oral once daily administration
|
Citalopram
oral, once daily administration
Citalopram: oral once daily administration
|
Pipamperone
oral, once daily administration
Pipamperone: oral once daily administration
|
|---|---|---|---|
|
Overall Study
STARTED
|
185
|
185
|
185
|
|
Overall Study
COMPLETED
|
117
|
131
|
135
|
|
Overall Study
NOT COMPLETED
|
68
|
54
|
50
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pipamperone/Citalopram (PNB01) Versus Citalopram (CIT) and Versus Pipamperone (PIP) in Major Depressive Disorder (MDD)
Baseline characteristics by cohort
| Measure |
PNB01
n=185 Participants
oral, once daily administration
PNB01 fixed dose combination of pipamperone and citalopram: oral once daily administration
|
Citalopram
n=185 Participants
oral, once daily administration
Citalopram: oral once daily administration
|
Pipamperone
n=185 Participants
oral, once daily administration
Pipamperone: oral once daily administration
|
Total
n=555 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18 - 60 years
|
184 Participants
n=5 Participants
|
182 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
545 Participants
n=4 Participants
|
|
Age, Customized
> 60 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
329 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
226 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
53 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
161 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
116 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
355 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From (end of) Week 2 visit to (end of) Week 6 visitPopulation: Full Analysis Set (FAS): The FAS consists of all patients who are randomized and were administered at least one dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group to which they were randomized (intention-to-treat principle), irrespective of the study treatment received.
Early and Sustained Response (ESR) is defined as a MADRS total score reduction from Baseline of 50% or more and a MADRS total score ≤16 at Week 2, Week 3, Week 4, and Week 6.
Outcome measures
| Measure |
PNB01
n=176 Participants
oral, once daily administration
PNB01 fixed dose combination of pipamperone and citalopram: oral once daily administration
|
Citalopram
n=174 Participants
oral, once daily administration
Citalopram: oral once daily administration
|
Pipamperone
n=181 Participants
oral, once daily administration
Pipamperone: oral once daily administration
|
|---|---|---|---|
|
Early and Sustained (Antidepressant) Response (ESR) Rate
|
17 Participants
|
17 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to (end of) Week 6Population: Secondary Outcome Measures were pre-specified to be completed based on significance of the Primary Outcome Measure. Secondary Outcome Measures were therefore not completed.
Change from baseline in total score on the Montgomery-Asberg Depression Rating Scale (MADRS) after 6 weeks of study treatment as assessed by the patient using an Interactive Voice Response System (IVRS) via telephone The MADRS scale is a widely used and well-validated 10-item diagnostic questionnaire designed to measure the severity of depressive episodes in patients with mood disorders. The 10 items are all rated on a scale from 0 to 6 (resulting in a maximum total score of 60 points) and include 'apparent sadness', 'reported sadness', 'inner tension', 'reduced sleep', 'reduced appetite', 'concentration difficulties', 'lassitude', 'inability to feel', 'pessimistic thoughts' and 'suicidal thoughts'. Higher scores indicative of greater depressive symptomology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Baseline (Day 1) to (end of) Week 6 visitPopulation: Secondary Outcome Measures were pre-specified to be completed based on significance of the Primary Outcome Measure. Secondary Outcome Measures were therefore not completed.
Change from baseline in total score on the Sheehan Disability Scale (SDS) after 6 weeks of study treatment as assessed by the patient using an Interactive Voice Response System (IVRS) via telephone The SDS is a generic brief self-report tool that was developed to assess functional impairment in three inter-related domains; 1) work or school, 2) social life and 3) family life. The patient rates the extent to which work/school, social life and home life or family responsibilities are impaired by his or her symptoms on a 10-point visual analog scale. Total scores range from a minimum of 0 to a maximum of 30 (0 unimpaired, 30 highly impaired).
Outcome measures
Outcome data not reported
Adverse Events
PNB01
Serious events: 3 serious events
Other events: 127 other events
Deaths: 0 deaths
Citalopram
Serious events: 4 serious events
Other events: 131 other events
Deaths: 0 deaths
Pipamperone
Serious events: 1 serious events
Other events: 118 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PNB01
n=185 participants at risk
oral, once daily administration
PNB01 fixed dose combination of pipamperone and citalopram: oral once daily administration
|
Citalopram
n=185 participants at risk
oral, once daily administration
Citalopram: oral once daily administration
|
Pipamperone
n=185 participants at risk
oral, once daily administration
Pipamperone: oral once daily administration
|
|---|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.54%
1/185 • Number of events 1 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
0.00%
0/185 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
0.00%
0/185 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
|
Metabolism and nutrition disorders
dehydratation
|
0.54%
1/185 • Number of events 1 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
0.00%
0/185 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
0.00%
0/185 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.54%
1/185 • Number of events 1 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
0.00%
0/185 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
0.00%
0/185 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.54%
1/185 • Number of events 1 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
0.00%
0/185 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
0.00%
0/185 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
|
Gastrointestinal disorders
gastric ulcer
|
0.00%
0/185 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
0.54%
1/185 • Number of events 1 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
0.00%
0/185 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/185 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
0.54%
1/185 • Number of events 1 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
0.00%
0/185 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/185 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
0.54%
1/185 • Number of events 1 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
0.00%
0/185 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
|
Injury, poisoning and procedural complications
Ulna Fracture
|
0.00%
0/185 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
0.54%
1/185 • Number of events 1 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
0.00%
0/185 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
|
Nervous system disorders
Syncope
|
0.00%
0/185 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
0.54%
1/185 • Number of events 1 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
0.00%
0/185 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
|
Psychiatric disorders
Depression
|
0.00%
0/185 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
0.54%
1/185 • Number of events 1 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
0.00%
0/185 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
|
Psychiatric disorders
suicidal ideation
|
0.00%
0/185 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
0.54%
1/185 • Number of events 1 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
0.00%
0/185 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/185 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
0.00%
0/185 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
0.54%
1/185 • Number of events 1 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
Other adverse events
| Measure |
PNB01
n=185 participants at risk
oral, once daily administration
PNB01 fixed dose combination of pipamperone and citalopram: oral once daily administration
|
Citalopram
n=185 participants at risk
oral, once daily administration
Citalopram: oral once daily administration
|
Pipamperone
n=185 participants at risk
oral, once daily administration
Pipamperone: oral once daily administration
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.9%
9/185 • Number of events 11 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
9.2%
17/185 • Number of events 19 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
0.54%
1/185 • Number of events 1 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
|
Gastrointestinal disorders
Dry Mouth
|
9.7%
18/185 • Number of events 18 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
5.4%
10/185 • Number of events 11 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
8.6%
16/185 • Number of events 17 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
|
Gastrointestinal disorders
Nausea
|
8.6%
16/185 • Number of events 17 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
15.1%
28/185 • Number of events 30 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
7.6%
14/185 • Number of events 16 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
|
Nervous system disorders
Dizziness
|
5.4%
10/185 • Number of events 13 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
6.5%
12/185 • Number of events 14 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
5.4%
10/185 • Number of events 11 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
|
Nervous system disorders
Headache
|
10.8%
20/185 • Number of events 20 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
10.8%
20/185 • Number of events 25 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
10.3%
19/185 • Number of events 21 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
|
Nervous system disorders
Sedation
|
2.2%
4/185 • Number of events 5 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
3.8%
7/185 • Number of events 7 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
4.3%
8/185 • Number of events 8 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
|
Nervous system disorders
Somnolence
|
15.7%
29/185 • Number of events 29 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
10.8%
20/185 • Number of events 23 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
6.5%
12/185 • Number of events 13 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
|
Psychiatric disorders
Insomnia
|
5.9%
11/185 • Number of events 12 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
10.8%
20/185 • Number of events 20 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
4.9%
9/185 • Number of events 10 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
|
General disorders
Fatigue
|
3.2%
6/185 • Number of events 7 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
4.9%
9/185 • Number of events 10 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
2.7%
5/185 • Number of events 6 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
8/185 • Number of events 8 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
5.4%
10/185 • Number of events 10 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
3.2%
6/185 • Number of events 6 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
|
Investigations
Weight Increase
|
4.9%
9/185 • Number of events 10 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
1.1%
2/185 • Number of events 2 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
8.1%
15/185 • Number of events 15 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
|
Metabolism and nutrition disorders
Decreased Appetitie
|
2.2%
4/185 • Number of events 5 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
5.4%
10/185 • Number of events 11 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
1.6%
3/185 • Number of events 3 • 10 weeks + follow-up 1 week
Safety Set (SS): The SS consists of all patients who are randomized and were administered at least 1 dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group of the study treatment that was actually received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place