Trial Outcomes & Findings for Lexapro and Pramipexole and to Treat Major Depression (NCT NCT00086307)
NCT ID: NCT00086307
Last Updated: 2013-01-28
Results Overview
The Montgomery Asberg Depression Rating Scale (MADRS) is a 10 item scale for assessing the severity of depression. Items are rated on a scale of 0 to 6, so the maximum score is 60 and the minimum is 0, where 60 is the most severe depression. Scores of 18 or greater are generally considered to indicate a moderate level of depression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
Weekly
Results posted on
2013-01-28
Participant Flow
Participant milestones
| Measure |
Pramipexole
Patients receive pramipexole and placebo.
|
Escitalopram
Patients receive escitalopram and placebo.
|
Escitalopram and Pramipexole
Patients receive escitalopram and pramipexole.
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
13
|
|
Overall Study
COMPLETED
|
11
|
12
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
8
|
Reasons for withdrawal
| Measure |
Pramipexole
Patients receive pramipexole and placebo.
|
Escitalopram
Patients receive escitalopram and placebo.
|
Escitalopram and Pramipexole
Patients receive escitalopram and pramipexole.
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
2
|
|
Overall Study
Shortness of breath and muscle spasms
|
1
|
0
|
0
|
|
Overall Study
Nausea and headaches
|
0
|
0
|
1
|
|
Overall Study
Constipation and sleepiness
|
0
|
0
|
1
|
|
Overall Study
Suicidal ideation
|
0
|
0
|
1
|
|
Overall Study
Fatigue and difficulty falling asleep
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
Baseline Characteristics
Lexapro and Pramipexole and to Treat Major Depression
Baseline characteristics by cohort
| Measure |
Pramipexole
n=13 Participants
Patients receive pramipexole and placebo.
|
Escitalopram
n=13 Participants
Patients receive escitalopram and placebo.
|
Escitalopram and Pramipexole
n=13 Participants
Patients receive escitalopram and pramipexole.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age Continuous
|
44.8 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
45.6 years
STANDARD_DEVIATION 13.6 • n=7 Participants
|
45.3 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
45.3 years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
13 participants
n=5 Participants
|
39 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: WeeklyPopulation: All patients with at least one post-baseline measurement were included in the analysis.
The Montgomery Asberg Depression Rating Scale (MADRS) is a 10 item scale for assessing the severity of depression. Items are rated on a scale of 0 to 6, so the maximum score is 60 and the minimum is 0, where 60 is the most severe depression. Scores of 18 or greater are generally considered to indicate a moderate level of depression.
Outcome measures
| Measure |
Pramipexole
n=13 Participants
Patients receive pramipexole and placebo.
|
Escitalopram
n=13 Participants
Patients receive escitalopram and placebo.
|
Escitalopram and Pramipexole
n=13 Participants
Patients receive escitalopram and pramipexole.
|
|---|---|---|---|
|
Montgomery Asberg Depression Rating Scale (MADRS)
|
22.629 Score on a scale
Standard Error 1.508
|
26.102 Score on a scale
Standard Error 1.507
|
29.455 Score on a scale
Standard Error 1.732
|
Adverse Events
Pramipexole
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Escitalopram
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Escitalopram and Pramipexole
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pramipexole
n=13 participants at risk
Patients receive pramipexole and placebo.
|
Escitalopram
n=13 participants at risk
Patients receive escitalopram and placebo.
|
Escitalopram and Pramipexole
n=13 participants at risk
Patients receive escitalopram and pramipexole.
|
|---|---|---|---|
|
General disorders
Headache
|
23.1%
3/13 • Number of events 3
|
23.1%
3/13 • Number of events 3
|
30.8%
4/13 • Number of events 4
|
|
General disorders
Dizziness
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
|
Eye disorders
Eye Irritation
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
0.00%
0/13
|
|
Ear and labyrinth disorders
Earache
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
0.00%
0/13
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
|
General disorders
Dry Mouth
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Nasal Congestion
|
0.00%
0/13
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Sore Throat
|
0.00%
0/13
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Ailment
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
0.00%
0/13
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/13
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
Cardiac disorders
Hypertension
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
7.7%
1/13 • Number of events 1
|
23.1%
3/13 • Number of events 3
|
15.4%
2/13 • Number of events 2
|
|
General disorders
Nausea
|
23.1%
3/13 • Number of events 3
|
7.7%
1/13 • Number of events 1
|
38.5%
5/13 • Number of events 5
|
|
General disorders
Vomiting
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
Renal and urinary disorders
Constipation
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
|
General disorders
Flatulence
|
15.4%
2/13 • Number of events 2
|
7.7%
1/13 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Stool Discoloration
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
0.00%
0/13
|
|
General disorders
Appetite Increase
|
0.00%
0/13
|
23.1%
3/13 • Number of events 3
|
15.4%
2/13 • Number of events 2
|
|
General disorders
Appetite Decrease
|
7.7%
1/13 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
30.8%
4/13 • Number of events 4
|
|
General disorders
Increased Thirst
|
7.7%
1/13 • Number of events 1
|
15.4%
2/13 • Number of events 2
|
7.7%
1/13 • Number of events 1
|
|
Renal and urinary disorders
Painful Urination
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
0.00%
0/13
|
|
Renal and urinary disorders
Increased Frequency of Urination
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
|
Reproductive system and breast disorders
Menstrual Irregularity
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
9.1%
1/11 • Number of events 1
|
|
Reproductive system and breast disorders
Premenstrual Tension
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
0.00%
0/11
|
|
General disorders
Increased Libido
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
0.00%
0/13
|
|
General disorders
Decreased Libido
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
0.00%
0/13
|
|
General disorders
Sexual Dysfunction
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle/Bone/Joint Pain
|
0.00%
0/13
|
23.1%
3/13 • Number of events 3
|
23.1%
3/13 • Number of events 3
|
|
General disorders
Tic Movements
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
|
Skin and subcutaneous tissue disorders
Dermatological Irritation
|
23.1%
3/13 • Number of events 3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
|
General disorders
Hair Problems
|
0.00%
0/13
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/13
|
23.1%
3/13 • Number of events 3
|
0.00%
0/13
|
|
General disorders
Increased Motor Activity
|
0.00%
0/13
|
0.00%
0/13
|
15.4%
2/13 • Number of events 2
|
|
General disorders
Decreased Motor Activity
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
0.00%
0/13
|
|
General disorders
Difficulty Falling Asleep
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
38.5%
5/13 • Number of events 5
|
|
General disorders
Early Morning Awakening
|
0.00%
0/13
|
15.4%
2/13 • Number of events 2
|
30.8%
4/13 • Number of events 4
|
|
General disorders
Interrupted Sleep
|
7.7%
1/13 • Number of events 1
|
15.4%
2/13 • Number of events 2
|
23.1%
3/13 • Number of events 3
|
|
General disorders
Drowsiness
|
0.00%
0/13
|
30.8%
4/13 • Number of events 4
|
0.00%
0/13
|
|
General disorders
Slurred Speech
|
0.00%
0/13
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Concentration Difficulty
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
15.4%
2/13 • Number of events 2
|
|
General disorders
Memory Problems
|
7.7%
1/13 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Psychiatric disorders
Depression
|
7.7%
1/13 • Number of events 1
|
15.4%
2/13 • Number of events 2
|
15.4%
2/13 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
15.4%
2/13 • Number of events 2
|
23.1%
3/13 • Number of events 3
|
30.8%
4/13 • Number of events 4
|
|
Psychiatric disorders
Irritability
|
7.7%
1/13 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Psychiatric disorders
Suicidal Ideas
|
0.00%
0/13
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Breast pain or swelling
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
0.00%
0/11
|
|
Gastrointestinal disorders
Diarrhea
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
0.00%
0/13
|
|
General disorders
Accidental injury
|
0.00%
0/13
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place