Trial Outcomes & Findings for Quetiapine XR Versus Sertraline in Acute Bipolar Depression as add-on Therapy (NCT NCT00857584)
NCT ID: NCT00857584
Last Updated: 2012-04-18
Results Overview
MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)
COMPLETED
PHASE3
27 participants
baseline, week 2
2012-04-18
Participant Flow
Participant milestones
| Measure |
Quetiapine Extended Release
Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
|
Setraline
Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
|
Overall Study
Week 1
|
14
|
13
|
|
Overall Study
Week 2
|
14
|
11
|
|
Overall Study
Week 4
|
11
|
9
|
|
Overall Study
Week 8
|
10
|
8
|
|
Overall Study
COMPLETED
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Quetiapine Extended Release
Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
|
Setraline
Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Physician Decision
|
1
|
1
|
Baseline Characteristics
Quetiapine XR Versus Sertraline in Acute Bipolar Depression as add-on Therapy
Baseline characteristics by cohort
| Measure |
Quetiapine Extended Release
n=14 Participants
Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
|
Setraline
n=13 Participants
Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
48.5 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
43.3 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
46.07 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Montgomery Asberg Depression Rating Scale (MADRS) total score, Continuous
|
29.5 score on a scale
STANDARD_DEVIATION 5.0 • n=5 Participants
|
28.2 score on a scale
STANDARD_DEVIATION 5.8 • n=7 Participants
|
28.9 score on a scale
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
Clinical Impression Global Scale - Bipolar total score (CGI-BP-M), Continuous
|
5.1 score on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
5.3 score on a scale
STANDARD_DEVIATION 0.8 • n=7 Participants
|
5.2 score on a scale
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Hamilton Anxiety Rating Scale (HARS) total score, Continuous
|
22.4 score on a scale
STANDARD_DEVIATION 4.03 • n=5 Participants
|
17.6 score on a scale
STANDARD_DEVIATION 4.46 • n=7 Participants
|
20.04 score on a scale
STANDARD_DEVIATION 7.38 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, week 2Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology. Safety data were analyzed for patients who received at least one dose of study medication.
MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)
Outcome measures
| Measure |
Quetiapine Extended Release
n=14 Participants
Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
|
Setraline
n=11 Participants
Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
|
|---|---|---|
|
The Mean Change From Baseline to Week 2 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
|
-13.1 score on a scale
Interval -18.6 to -7.6
|
-6.6 score on a scale
Interval -12.6 to -0.6
|
SECONDARY outcome
Timeframe: baseline, week 1Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.
MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)
Outcome measures
| Measure |
Quetiapine Extended Release
n=14 Participants
Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
|
Setraline
n=13 Participants
Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
|
|---|---|---|
|
The Mean Change From Baseline to Week 1 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
|
-9.5 score on a scale
Interval -13.8 to -5.1
|
-8.6 score on a scale
Interval -14.5 to -2.6
|
SECONDARY outcome
Timeframe: baseline, week 4Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.
MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)
Outcome measures
| Measure |
Quetiapine Extended Release
n=11 Participants
Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
|
Setraline
n=9 Participants
Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
|
|---|---|---|
|
The Mean Change From Baseline to Week 4 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
|
-16.1 score on a scale
Interval -21.4 to -10.9
|
-17.7 score on a scale
Interval -25.8 to -9.7
|
SECONDARY outcome
Timeframe: baseline. week 8Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.
MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)
Outcome measures
| Measure |
Quetiapine Extended Release
n=10 Participants
Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
|
Setraline
n=8 Participants
Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
|
|---|---|---|
|
The Mean Change From Baseline to Week 8 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
|
-19.4 score on a scale
Interval -24.2 to -14.5
|
-18.2 score on a scale
Interval -24.8 to -11.6
|
SECONDARY outcome
Timeframe: baseline, week 1Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology
CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity)
Outcome measures
| Measure |
Quetiapine Extended Release
n=14 Participants
Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
|
Setraline
n=13 Participants
Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
|
|---|---|---|
|
The Mean Change From Baseline to Week 1 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score
|
-0.79 score on a scale
Interval -1.47 to -0.1
|
-1.08 score on a scale
Interval -2.14 to -0.02
|
SECONDARY outcome
Timeframe: baseline, week 2Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.
CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity)
Outcome measures
| Measure |
Quetiapine Extended Release
n=14 Participants
Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
|
Setraline
n=11 Participants
Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
|
|---|---|---|
|
The Mean Change From Baseline to Week 2 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score
|
-1.36 score on a scale
Interval -2.19 to -0.52
|
-1.00 score on a scale
Interval -2.2 to -0.2
|
SECONDARY outcome
Timeframe: baseline, week 4Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.
CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity)
Outcome measures
| Measure |
Quetiapine Extended Release
n=11 Participants
Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
|
Setraline
n=9 Participants
Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
|
|---|---|---|
|
The Mean Change From Baseline to Week 4 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score
|
-2.09 score on a scale
Interval -3.19 to -0.99
|
-2.56 score on a scale
Interval -4.15 to -0.97
|
SECONDARY outcome
Timeframe: baseline, week 8Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.
CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 (higher scores indicating a greater clinical severity)
Outcome measures
| Measure |
Quetiapine Extended Release
n=10 Participants
Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
|
Setraline
n=8 Participants
Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
|
|---|---|---|
|
The Mean Change From Baseline to Week 8 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score
|
-2.9 score on a scale
Interval -4.14 to -1.66
|
-2.88 score on a scale
Interval -4.25 to -1.5
|
SECONDARY outcome
Timeframe: baseline, week 4Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.
HARS assesses severity of anxiety symptoms. It ranges from a minimum of 0 to a maximum of 56 (higher scores indicating a greater severity of anxiety symptoms)
Outcome measures
| Measure |
Quetiapine Extended Release
n=11 Participants
Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
|
Setraline
n=9 Participants
Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
|
|---|---|---|
|
The Mean Change From Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HARS) Total Score
|
-13.4 score on a scale
Interval -17.6 to -9.1
|
-8.9 score on a scale
Interval -14.3 to -3.4
|
SECONDARY outcome
Timeframe: baseline, week 8Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.
HARS assesses severity of anxiety symptoms. It ranges from a minimum of 0 to a maximum of 56 (higher scores indicating a greater severity of anxiety symptoms)
Outcome measures
| Measure |
Quetiapine Extended Release
n=10 Participants
Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
|
Setraline
n=8 Participants
Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
|
|---|---|---|
|
The Mean Change From Baseline to Week 8 in the Hamilton Anxiety Rating Scale (HARS) Total Score
|
-13.1 score on a scale
Interval -18.01 to -8.2
|
-10.6 score on a scale
Interval -15.5 to -5.7
|
SECONDARY outcome
Timeframe: week 1Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.
Number of patients responded to the treatment at week 1, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 1. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms.
Outcome measures
| Measure |
Quetiapine Extended Release
n=14 Participants
Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
|
Setraline
n=13 Participants
Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
|
|---|---|---|
|
Number of Patients Response at Week 1
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: week 2Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.
Number of patients responded to the treatment at week 2, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 2. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms.
Outcome measures
| Measure |
Quetiapine Extended Release
n=14 Participants
Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
|
Setraline
n=11 Participants
Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
|
|---|---|---|
|
Number of Patients With Response at Week 2
|
8 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: week 4Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.
Number of patients responded to the treatment at week 4, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 4. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms.
Outcome measures
| Measure |
Quetiapine Extended Release
n=11 Participants
Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
|
Setraline
n=9 Participants
Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
|
|---|---|---|
|
Number of Patients With Response at Week 4.
|
8 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: week 8Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.
Number of patients responded to the treatment at week 8, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 8. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms.
Outcome measures
| Measure |
Quetiapine Extended Release
n=10 Participants
Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
|
Setraline
n=8 Participants
Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
|
|---|---|---|
|
Number of Patients With Response at Week 8.
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: week 1Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.
Number of patients who achieved remission at week 1, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms.
Outcome measures
| Measure |
Quetiapine Extended Release
n=14 Participants
Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
|
Setraline
n=13 Participants
Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
|
|---|---|---|
|
Number of Patients With Remission at Week 1.
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: week 2Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.
Number of patients who achieved remission at week 2, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms.
Outcome measures
| Measure |
Quetiapine Extended Release
n=14 Participants
Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
|
Setraline
n=11 Participants
Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
|
|---|---|---|
|
Number of Patients With Remission at Week 2.
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: week 4Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.
Number of patients who achieved remission at week 4, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms.
Outcome measures
| Measure |
Quetiapine Extended Release
n=11 Participants
Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
|
Setraline
n=9 Participants
Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
|
|---|---|---|
|
Number of Patients With Remission at Week 4.
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: week 8Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology
Number of patients who achieved remission at week 8, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms.
Outcome measures
| Measure |
Quetiapine Extended Release
n=10 Participants
Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
|
Setraline
n=8 Participants
Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
|
|---|---|---|
|
Number of Patients With Remission at Week 8.
|
3 Participants
|
4 Participants
|
Adverse Events
Quetiapine Extended Release
Setraline
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Quetiapine Extended Release
n=14 participants at risk
Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
|
Setraline
n=13 participants at risk
Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
|
|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
21.4%
3/14
|
0.00%
0/13
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14
|
15.4%
2/13
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/14
|
15.4%
2/13
|
|
Metabolism and nutrition disorders
Hyperphagia
|
7.1%
1/14
|
0.00%
0/13
|
|
Nervous system disorders
Somnolence
|
35.7%
5/14
|
7.7%
1/13
|
|
Nervous system disorders
Tremor
|
14.3%
2/14
|
7.7%
1/13
|
|
Nervous system disorders
Dysarthria
|
7.1%
1/14
|
0.00%
0/13
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/14
|
15.4%
2/13
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/14
|
7.7%
1/13
|
|
Psychiatric disorders
Disorientation
|
7.1%
1/14
|
0.00%
0/13
|
|
Psychiatric disorders
Decreased libido
|
0.00%
0/14
|
7.7%
1/13
|
|
General disorders
Chest discomfort
|
7.1%
1/14
|
0.00%
0/13
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place