Trial Outcomes & Findings for Org 24448 to Treat Major Depression (NCT NCT00113022)
NCT ID: NCT00113022
Last Updated: 2012-07-13
Results Overview
The MADRS is a measure of depression severity examined on a weekly basis. The minimum score on the 10 item scale is 0 indicating no depression. The maximum score is 60 indicating a very severe depression. Scores of 18 and above are generally considered to suggest significant levels of depression.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
8 weeks
Results posted on
2012-07-13
Participant Flow
Patient with major depression who do not have a serious, unstable medical illness and are 21 to 55 years of age may be eligible. Candidates are screened with a psychiatric and medical history, diagnostic interview, physical examination, electrocardiogram, blood tests and, for women, a pregnancy test.
Participants are tapered off anti-depression drugs (and any other medications not allowed) over a 3-week period and then begin a 2-week drug-free period. During these 2 weeks they have an electroencephalogram (EEG) with light stimulation, and those whose EEG indicates a seizure disorder are excluded from the study.
Participant milestones
| Measure |
Org 24448
Blinded, active experimental compound. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
|
Placebo
Blinded placebo. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Org 24448 to Treat Major Depression
Baseline characteristics by cohort
| Measure |
Org 24448
n=5 Participants
Blinded, active experimental compound. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
|
Placebo
n=4 Participants
Blinded placebo. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
|
Total
n=9 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
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
38.20 years
STANDARD_DEVIATION 7.89 • n=5 Participants
|
40.00 years
STANDARD_DEVIATION 13.69 • n=7 Participants
|
39.00 years
STANDARD_DEVIATION 10.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksThe MADRS is a measure of depression severity examined on a weekly basis. The minimum score on the 10 item scale is 0 indicating no depression. The maximum score is 60 indicating a very severe depression. Scores of 18 and above are generally considered to suggest significant levels of depression.
Outcome measures
| Measure |
Org 24448
n=5 Participants
Blinded, active experimental compound. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
|
Placebo
n=4 Participants
Blinded placebo. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
|
|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
|
26.425 Scores on a scale
Standard Error 10.628
|
24.205 Scores on a scale
Standard Error 12.905
|
Adverse Events
Org 24448
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Org 24448
n=5 participants at risk
Blinded, active experimental compound. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
|
Placebo
n=4 participants at risk
Blinded placebo. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
|
|---|---|---|
|
Blood and lymphatic system disorders
Decreased white blood cell and absolute neutrophils counts
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
Other adverse events
| Measure |
Org 24448
n=5 participants at risk
Blinded, active experimental compound. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
|
Placebo
n=4 participants at risk
Blinded placebo. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
|
|---|---|---|
|
Gastrointestinal disorders
Increased thirst
|
20.0%
1/5 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
|
Nervous system disorders
Memory problems
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
General disorders
Headache
|
20.0%
1/5 • Number of events 1
|
50.0%
2/4 • Number of events 2
|
|
General disorders
Pain
|
0.00%
0/5
|
75.0%
3/4 • Number of events 3
|
|
General disorders
Dental problems
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
Psychiatric disorders
Suicidal ideas
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Dizziness
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
General disorders
Dry mouth
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
Additional Information
Dr. Carlos Zarate
Experimental Therapeutics and Pathophysiology Branch, NIMH
Phone: 301-451-0861
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place