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Trial record 9 of 34397 for:    Placebo AND placebo effect

Placebo Effects in the Treatment of Depression: Cognitive and Neural Mechanisms

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ClinicalTrials.gov Identifier: NCT01919216
Recruitment Status : Completed
First Posted : August 8, 2013
Results First Posted : January 5, 2018
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Intervention Drug: Citalopram
Enrollment 65
Recruitment Details 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.
Pre-assignment Details 11 enrolled participants were lost to follow up prior to randomization.
Arm/Group Title Open Track Placebo Track - Citalopram Placebo Track - Placebo
Hide Arm/Group Description

Open treatment with 20mg of citalopram, increased to 40mg if depression has not remitted at week 4.

Citalopram

Blinded treatment with either citalopram 20mg, increased to citalopram 40mg at week 4 if depression has not remitted.

Citalopram

Blinded treatment with either placebo
Period Title: Overall Study
Started 28 21 5
Completed 26 20 4
Not Completed 2 1 1
Arm/Group Title Open Track Placebo Track - Citalopram Placebo Track - Placebo Total
Hide Arm/Group Description

Open treatment with 20mg of citalopram, increased to 40mg if depression has not remitted at week 4.

Citalopram

Blinded treatment with citalopram 20mg , increased to citalopram 40mg at week 4 if depression has not remitted.

Citalopram

Blinded treatment with placebo Total of all reporting groups
Overall Number of Baseline Participants 26 20 4 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 20 participants 4 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
26
 100.0%
20
 100.0%
4
 100.0%
50
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 20 participants 4 participants 50 participants
41.4  (12) 43.8  (10.7) 34.3  (10.2) 41.79  (11.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 20 participants 4 participants 50 participants
Female
17
  65.4%
10
  50.0%
3
  75.0%
30
  60.0%
Male
9
  34.6%
10
  50.0%
1
  25.0%
20
  40.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 20 participants 4 participants 50 participants
Hispanic or Latino
5
  19.2%
2
  10.0%
1
  25.0%
8
  16.0%
Not Hispanic or Latino
21
  80.8%
18
  90.0%
3
  75.0%
42
  84.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 20 participants 4 participants 50 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
  11.5%
0
   0.0%
0
   0.0%
3
   6.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
  26.9%
6
  30.0%
1
  25.0%
14
  28.0%
White
12
  46.2%
13
  65.0%
3
  75.0%
28
  56.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
  15.4%
1
   5.0%
0
   0.0%
5
  10.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 26 participants 20 participants 4 participants 50 participants
26
 100.0%
20
 100.0%
4
 100.0%
50
 100.0%
Hamilton Rating Scale for Depression   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 26 participants 20 participants 4 participants 50 participants
25.7  (5.5) 25.7  (4.1) 23.8  (2.8) 25.55  (4.8)
[1]
Measure Description: 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.
Hamilton Anxiety Rating Scale (HAM-A)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 26 participants 20 participants 4 participants 50 participants
13.2  (4.9) 15.1  (4.8) 16.7  (9.2) 14.24  (5.34)
[1]
Measure Description: HAM-A consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe). The summation of each of the 14 individually rated items will yield a comprehensive score in the range of 0 to 56. It has been predetermined that the results of the evaluation can be interpreted as follows. A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity. Lastly, a score of 25 to 30 indicates a moderate to severe anxiety severity.
CGI Severity   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 26 participants 20 participants 4 participants 50 participants
4.4  (0.6) 4.3  (0.5) 4.3  (0.6) 4.35  (0.56)
[1]
Measure Description: Clinical Global Impression – Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment: 0 normal, not at all ill to 7 Among the most extremely ill patients
Quick Inventory of Depressive Symptoms—Self Report (QIDS-SR) 16 Item Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 26 participants 20 participants 4 participants 50 participants
19.7  (5.2) 19.8  (7.2) 17.8  (7.5) 19.59  (6.27)
[1]
Measure Description:

The16 item Quick Inventory of Depressive Symptomatology (QIDS) contains 16 questions score from 0 to 3 each.

Qids score 1-5, not depressed; 6-10, Mild depression; 11-15, Moderate depression; 16-20, Severe depression; 21-27, very severe depression

1.Primary Outcome
Title Hamilton Rating Scale for Depression
Hide Description 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.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Open Track Placebo Track - Citalopram Placebo Track - Placebo
Hide Arm/Group Description:

Open treatment with 20mg of citalopram, increased to 40mg if depression has not remitted at week 4.

Citalopram

Blinded treatment with either citalopram 20mg, increased to citalopram 40mg or placebo at week 4 if depression has not remitted.

Citalopram

Blinded treatment with placebo
Overall Number of Participants Analyzed 26 20 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
10.79  (8.96) 15.30  (9.2) 12.75  (5.188)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open Track Placebo Track - Citalopram Placebo Track - Placebo
Hide Arm/Group Description

Open treatment with 20mg of citalopram, increased to 40mg if depression has not remitted at week 4.

Citalopram

Blinded treatment with citalopram 20mg, increased to citalopram 40mg or placebo at week 4 if depression has not remitted.

Citalopram

Blinded treatment with placebo
All-Cause Mortality
Open Track Placebo Track - Citalopram Placebo Track - Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/20 (0.00%)   0/4 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Open Track Placebo Track - Citalopram Placebo Track - Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/20 (0.00%)   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Open Track Placebo Track - Citalopram Placebo Track - Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/20 (0.00%)   0/4 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bret Rutherford
Organization: New York State Psychiatric Institute
Phone: 6467748660
EMail: brr8@cumc.columbia.edu
Layout table for additonal information
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01919216     History of Changes
Other Study ID Numbers: 6038/6996R
K23MH085236 ( U.S. NIH Grant/Contract )
First Submitted: August 5, 2013
First Posted: August 8, 2013
Results First Submitted: July 24, 2017
Results First Posted: January 5, 2018
Last Update Posted: February 26, 2019