Trial Outcomes & Findings for Placebo Effects in the Treatment of Depression: Cognitive and Neural Mechanisms (NCT NCT01919216)
NCT ID: NCT01919216
Last Updated: 2020-03-09
Results Overview
The patient is rated by a clinician among 24 dimensions with a score on a 3 or 5 point scale. A score of 0-9 is considered to be normal. Score between 10-18 is considered as mild depression, Scores between 19-26 indicate moderate, scores between 27-34 indicate severe, and score between 35-75 indicate very severe depression.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
65 participants
Primary outcome timeframe
8 weeks
Results posted on
2020-03-09
Participant Flow
This study was conducted in the Adult and Late Life Depression Research Clinic at the New York State Psychiatric Institute (NYSPI) and approved by the NYSPI Institutional Review Board. Recruitment period started January 2010 and ended in June 2016.
11 enrolled participants were lost to follow up prior to randomization.
Participant milestones
| Measure |
Open Track
Open treatment with 20mg of citalopram, increased to 40mg if depression has not remitted at week 4.
Citalopram
|
Placebo Track - Citalopram
Blinded treatment with either citalopram 20mg, increased to citalopram 40mg at week 4 if depression has not remitted.
Citalopram
|
Placebo Track - Placebo
Blinded treatment with either placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
21
|
5
|
|
Overall Study
COMPLETED
|
26
|
20
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Placebo Effects in the Treatment of Depression: Cognitive and Neural Mechanisms
Baseline characteristics by cohort
| Measure |
Open Track
n=26 Participants
Open treatment with 20mg of citalopram, increased to 40mg if depression has not remitted at week 4.
Citalopram
|
Placebo Track - Citalopram
n=20 Participants
Blinded treatment with citalopram 20mg , increased to citalopram 40mg at week 4 if depression has not remitted.
Citalopram
|
Placebo Track - Placebo
n=4 Participants
Blinded treatment with placebo
|
Total
n=50 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
|
26 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
50 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
|
41.4 years
STANDARD_DEVIATION 12 • n=5 Participants
|
43.8 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
34.3 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
41.79 years
STANDARD_DEVIATION 11.36 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
28 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
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Hamilton Rating Scale for Depression
|
25.7 units on a scale
STANDARD_DEVIATION 5.5 • n=5 Participants
|
25.7 units on a scale
STANDARD_DEVIATION 4.1 • n=7 Participants
|
23.8 units on a scale
STANDARD_DEVIATION 2.8 • n=5 Participants
|
25.55 units on a scale
STANDARD_DEVIATION 4.8 • n=4 Participants
|
|
Hamilton Anxiety Rating Scale (HAM-A)
|
13.2 units on a scale
STANDARD_DEVIATION 4.9 • n=5 Participants
|
15.1 units on a scale
STANDARD_DEVIATION 4.8 • n=7 Participants
|
16.7 units on a scale
STANDARD_DEVIATION 9.2 • n=5 Participants
|
14.24 units on a scale
STANDARD_DEVIATION 5.34 • n=4 Participants
|
|
CGI Severity
|
4.4 units on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
4.3 units on a scale
STANDARD_DEVIATION 0.5 • n=7 Participants
|
4.3 units on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
4.35 units on a scale
STANDARD_DEVIATION 0.56 • n=4 Participants
|
|
Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR) 16 Item Scale
|
19.7 units on a scale
STANDARD_DEVIATION 5.2 • n=5 Participants
|
19.8 units on a scale
STANDARD_DEVIATION 7.2 • n=7 Participants
|
17.8 units on a scale
STANDARD_DEVIATION 7.5 • n=5 Participants
|
19.59 units on a scale
STANDARD_DEVIATION 6.27 • n=4 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: 54 subjects participated in the study, of whom 4 (2 in open track, 1 in placebo track - citalopram, 1 in placebo track - placebo) were lost to follow-up prior to taking the study medication and were excluded from the analyses.
The patient is rated by a clinician among 24 dimensions with a score on a 3 or 5 point scale. A score of 0-9 is considered to be normal. Score between 10-18 is considered as mild depression, Scores between 19-26 indicate moderate, scores between 27-34 indicate severe, and score between 35-75 indicate very severe depression.
Outcome measures
| Measure |
Open Track
n=26 Participants
Open treatment with 20mg of citalopram, increased to 40mg if depression has not remitted at week 4.
Citalopram
|
Placebo Track - Citalopram
n=20 Participants
Blinded treatment with either citalopram 20mg, increased to citalopram 40mg or placebo at week 4 if depression has not remitted.
Citalopram
|
Placebo Track - Placebo
n=4 Participants
Blinded treatment with placebo
|
|---|---|---|---|
|
Hamilton Rating Scale for Depression
|
10.79 units on a scale
Standard Deviation 8.96
|
15.30 units on a scale
Standard Deviation 9.2
|
12.75 units on a scale
Standard Deviation 5.188
|
Adverse Events
Open Track
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Track - Citalopram
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Track - Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place