Trial Outcomes & Findings for SSRI Effects on Depression and Immunity in HIV/AIDS (NCT NCT02620150)
NCT ID: NCT02620150
Last Updated: 2024-05-07
Results Overview
The outcome was determined by biological assays. Natural killer cells (NK cells) are white blood cells, a type of lymphocytes, that destroy infected and cancer cells through antigen independent recognition. Higher numbers indicate higher levels of cytotoxicity, that is, stronger cellular response. In the present summaries, we calculated the within-participant median value of the outcome over their available data at weeks 2, 4 and 10, and obtained overall and within-group summaries for these within-participant distributions.
COMPLETED
PHASE4
108 participants
Post randomization to 10 weeks
2024-05-07
Participant Flow
Participant milestones
| Measure |
Experimental
CCBT plus Escitalopram, oral, for 10 weeks, once daily, starting at 10mg/day. Tapered up or down, based on tolerability and clinical response, to 20mg/day max.
Escitalopram: 10 week trial
|
Placebo
CCBT plus Placebo, oral, for 10 weeks, once daily, starting at 10mg/day. Tapered up or down, based on tolerability and clinical response, to 20mg/day max.
Placebo: 10 week trial
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
53
|
|
Overall Study
COMPLETED
|
48
|
50
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SSRI Effects on Depression and Immunity in HIV/AIDS
Baseline characteristics by cohort
| Measure |
Experimental
n=55 Participants
CCBT plus Escitalopram, oral, for 10 weeks, once daily, starting at 10mg/day. Tapered up or down, based on tolerability and clinical response, to 20mg/day max.
Escitalopram: 10 week trial
|
Placebo
n=53 Participants
CCBT plus Placebo, oral, for 10 weeks, once daily, starting at 10mg/day. Tapered up or down, based on tolerability and clinical response, to 20mg/day max.
Placebo: 10 week trial
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.95 years
STANDARD_DEVIATION 11.99 • n=5 Participants
|
49.87 years
STANDARD_DEVIATION 10.97 • n=7 Participants
|
49.91 years
STANDARD_DEVIATION 11.45 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
34 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Transgender Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
49 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Overall Score on the Hamilton Depression Rating Scale
|
19.13 units on a scale
STANDARD_DEVIATION 4.90 • n=5 Participants
|
19.21 units on a scale
STANDARD_DEVIATION 5.07 • n=7 Participants
|
19.17 units on a scale
STANDARD_DEVIATION 4.96 • n=5 Participants
|
PRIMARY outcome
Timeframe: Post randomization to 10 weeksPopulation: 96 participants who provided responses at any of weeks 2, 4, and 10
The outcome was determined by biological assays. Natural killer cells (NK cells) are white blood cells, a type of lymphocytes, that destroy infected and cancer cells through antigen independent recognition. Higher numbers indicate higher levels of cytotoxicity, that is, stronger cellular response. In the present summaries, we calculated the within-participant median value of the outcome over their available data at weeks 2, 4 and 10, and obtained overall and within-group summaries for these within-participant distributions.
Outcome measures
| Measure |
Experimental
n=46 Participants
CCBT plus Escitalopram, oral, for 10 weeks, once daily, starting at 10mg/day. Tapered up or down, based on tolerability and clinical response, to 20mg/day max.
Escitalopram: 10 week trial
|
Placebo
n=50 Participants
CCBT plus Placebo, oral, for 10 weeks, once daily, starting at 10mg/day. Tapered up or down, based on tolerability and clinical response, to 20mg/day max.
Placebo: 10 week trial
|
|---|---|---|
|
Natural Killer Cell Activity, Measured in Lytic Units [Bryant J, Day R, Whiteside TL, and Herbeman RB: Calculation of Lytic Units for the Expression of Cell-mediated Cytotoxicity. J Immunol Methods 1992;146:91-103.]
|
224.06 Lytic Units
Interval 155.81 to 358.33
|
252.02 Lytic Units
Interval 150.16 to 360.28
|
PRIMARY outcome
Timeframe: Post randomization to 10 weeksPopulation: 96 participants who provided responses at any of weeks 2, 4, and 10
The outcome was determined by biological assays, which determined the number of NK cells, and the number of these cells that produced IFN-g, and combined these to calculate the outcome. Higher numbers are associated with stronger cellular response. In the present summaries, we calculated the within-participant median value of the outcome over their available data at weeks 2, 4 and 10, and obtained overall and within-group summaries for these within-participant distributions.
Outcome measures
| Measure |
Experimental
n=46 Participants
CCBT plus Escitalopram, oral, for 10 weeks, once daily, starting at 10mg/day. Tapered up or down, based on tolerability and clinical response, to 20mg/day max.
Escitalopram: 10 week trial
|
Placebo
n=50 Participants
CCBT plus Placebo, oral, for 10 weeks, once daily, starting at 10mg/day. Tapered up or down, based on tolerability and clinical response, to 20mg/day max.
Placebo: 10 week trial
|
|---|---|---|
|
Percent of Natural Killer (NK) Cells Producing Intracellular Interferon Gamma (IFN-g)
|
8.25 Percentage of NK cells producing IFN-g
Interval 3.5 to 16.0
|
5.40 Percentage of NK cells producing IFN-g
Interval 3.0 to 11.2
|
PRIMARY outcome
Timeframe: Post randomization to 10 weeksPopulation: 96 participants who provided responses at any of weeks 2, 4, and 10
The outcome was determined by biological assays, which determined the concentration of IL-6, expressed as pg/ml. Higher concentrations indicate greater inflammation. In the present summaries, we calculated the within-participant median value of the outcome over their available data at weeks 2, 4 and 10, and obtained overall and within-group summaries for these within-participant distributions.
Outcome measures
| Measure |
Experimental
n=46 Participants
CCBT plus Escitalopram, oral, for 10 weeks, once daily, starting at 10mg/day. Tapered up or down, based on tolerability and clinical response, to 20mg/day max.
Escitalopram: 10 week trial
|
Placebo
n=50 Participants
CCBT plus Placebo, oral, for 10 weeks, once daily, starting at 10mg/day. Tapered up or down, based on tolerability and clinical response, to 20mg/day max.
Placebo: 10 week trial
|
|---|---|---|
|
Units of Concentration of Plasma Interleukin 6 (IL-6), Expressed as Picograms Per Milliliter
|
2.52 Concentration of IL-6 (pcg/mL)
Interval 1.57 to 3.71
|
3.17 Concentration of IL-6 (pcg/mL)
Interval 2.21 to 4.64
|
PRIMARY outcome
Timeframe: Post randomization to 10 weeksPopulation: 96 participants who provided responses at any of weeks 2, 4, and 10
The outcome was determined by biological assays, which determined the concentration of CRP, expressed as mg/l. Higher concentrations indicate greater inflammation. In the present summaries, we calculated the within-participant median value of the outcome over their available data at weeks 2, 4 and 10, and obtained overall and within-group summaries for these within-participant distributions.
Outcome measures
| Measure |
Experimental
n=46 Participants
CCBT plus Escitalopram, oral, for 10 weeks, once daily, starting at 10mg/day. Tapered up or down, based on tolerability and clinical response, to 20mg/day max.
Escitalopram: 10 week trial
|
Placebo
n=50 Participants
CCBT plus Placebo, oral, for 10 weeks, once daily, starting at 10mg/day. Tapered up or down, based on tolerability and clinical response, to 20mg/day max.
Placebo: 10 week trial
|
|---|---|---|
|
Units of Concentration of Plasma C-Reactive Protein (CRP), Expressed as Milligrams Per Liter
|
3.75 Concentration of CRP (mg / l)
Interval 1.52 to 5.97
|
3.17 Concentration of CRP (mg / l)
Interval 2.21 to 4.64
|
SECONDARY outcome
Timeframe: 10 weeksPopulation: Participants who provided week 10 Hamilton Depression Rating Scale and Natural Killer cell activity data
The outcome was determined by calculating the Spearman correlation between decrease in overall score on the Hamilton Depression Rating Scale and decrease on Natural killer cell activity.
Outcome measures
| Measure |
Experimental
n=43 Participants
CCBT plus Escitalopram, oral, for 10 weeks, once daily, starting at 10mg/day. Tapered up or down, based on tolerability and clinical response, to 20mg/day max.
Escitalopram: 10 week trial
|
Placebo
n=47 Participants
CCBT plus Placebo, oral, for 10 weeks, once daily, starting at 10mg/day. Tapered up or down, based on tolerability and clinical response, to 20mg/day max.
Placebo: 10 week trial
|
|---|---|---|
|
Correlation Between Change in Overall Score on the Hamilton Depression Rating Scale, and Change in Natural Killer Cell Activity
|
0.24 Correlation coefficient
|
-0.28 Correlation coefficient
|
SECONDARY outcome
Timeframe: 10 weeksPopulation: Participants who provided week 10 Hamilton Depression Rating Scale and Intracellular Interferon Gamma (IFN-g) data
The outcome was determined by calculating the Spearman correlation between decrease in overall score on the Hamilton Depression Rating Scale and decrease on the Percent of Natural Killer (NK) Cells Producing Intracellular Interferon Gamma (IFN-g)
Outcome measures
| Measure |
Experimental
n=43 Participants
CCBT plus Escitalopram, oral, for 10 weeks, once daily, starting at 10mg/day. Tapered up or down, based on tolerability and clinical response, to 20mg/day max.
Escitalopram: 10 week trial
|
Placebo
n=45 Participants
CCBT plus Placebo, oral, for 10 weeks, once daily, starting at 10mg/day. Tapered up or down, based on tolerability and clinical response, to 20mg/day max.
Placebo: 10 week trial
|
|---|---|---|
|
Correlation Between Change in Overall Score on the Hamilton Depression Rating Scale, and Change in Percent of Natural Killer (NK) Cells Producing Intracellular Interferon Gamma (IFN-g)
|
-0.01 Correlation coefficient
|
0.12 Correlation coefficient
|
SECONDARY outcome
Timeframe: 10 weeksPopulation: Participants who provided week 10 Hamilton Depression Rating Scale and Plasma Interleukin 6 (IL-6) data
The outcome was determined by calculating the Spearman correlation between decrease in overall score on the Hamilton Depression Rating Scale and decrease on Units of Concentration of Plasma Interleukin 6 (IL-6)
Outcome measures
| Measure |
Experimental
n=43 Participants
CCBT plus Escitalopram, oral, for 10 weeks, once daily, starting at 10mg/day. Tapered up or down, based on tolerability and clinical response, to 20mg/day max.
Escitalopram: 10 week trial
|
Placebo
n=45 Participants
CCBT plus Placebo, oral, for 10 weeks, once daily, starting at 10mg/day. Tapered up or down, based on tolerability and clinical response, to 20mg/day max.
Placebo: 10 week trial
|
|---|---|---|
|
Correlation Between Change in Overall Score on the Hamilton Depression Rating Scale, and Change in Units of Concentration of Plasma Interleukin 6 (IL-6), Expressed as Picograms Per Milliliter
|
-0.16 Correlation coefficient
|
0.16 Correlation coefficient
|
SECONDARY outcome
Timeframe: 10 weeksPopulation: Participants who provided week 10 Hamilton Depression Rating Scale and Plasma C-Reactive Protein (CRP) data
The outcome was determined by calculating the Spearman correlation between decrease in overall score on the Hamilton Depression Rating Scale and decrease on Units of Concentration of Plasma C-Reactive Protein (CRP)
Outcome measures
| Measure |
Experimental
n=43 Participants
CCBT plus Escitalopram, oral, for 10 weeks, once daily, starting at 10mg/day. Tapered up or down, based on tolerability and clinical response, to 20mg/day max.
Escitalopram: 10 week trial
|
Placebo
n=43 Participants
CCBT plus Placebo, oral, for 10 weeks, once daily, starting at 10mg/day. Tapered up or down, based on tolerability and clinical response, to 20mg/day max.
Placebo: 10 week trial
|
|---|---|---|
|
Correlation Between Change in Overall Score on the Hamilton Depression Rating Scale, and Change in Units of Concentration of Plasma C-Reactive Protein (CRP), Expressed as Milligrams Per Liter
|
-0.33 Correlation coefficient
|
-0.04 Correlation coefficient
|
Adverse Events
Experimental
Placebo
Serious adverse events
| Measure |
Experimental
n=55 participants at risk
CCBT plus Escitalopram, oral, for 10 weeks, once daily, starting at 10mg/day. Tapered up or down, based on tolerability and clinical response, to 20mg/day max.
Escitalopram: 10 week trial
|
Placebo
n=53 participants at risk
CCBT plus Placebo, oral, for 10 weeks, once daily, starting at 10mg/day. Tapered up or down, based on tolerability and clinical response, to 20mg/day max.
Placebo: 10 week trial
|
|---|---|---|
|
Injury, poisoning and procedural complications
Death due to fentanyl/cocaine
|
1.8%
1/55 • Number of events 1 • 10 weeks
|
0.00%
0/53 • 10 weeks
|
|
Nervous system disorders
Stroke
|
1.8%
1/55 • Number of events 1 • 10 weeks
|
0.00%
0/53 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/55 • 10 weeks
|
1.9%
1/53 • Number of events 1 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/55 • 10 weeks
|
1.9%
1/53 • Number of events 1 • 10 weeks
|
Other adverse events
| Measure |
Experimental
n=55 participants at risk
CCBT plus Escitalopram, oral, for 10 weeks, once daily, starting at 10mg/day. Tapered up or down, based on tolerability and clinical response, to 20mg/day max.
Escitalopram: 10 week trial
|
Placebo
n=53 participants at risk
CCBT plus Placebo, oral, for 10 weeks, once daily, starting at 10mg/day. Tapered up or down, based on tolerability and clinical response, to 20mg/day max.
Placebo: 10 week trial
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
20.0%
11/55 • 10 weeks
|
13.2%
7/53 • 10 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
5/55 • 10 weeks
|
13.2%
7/53 • 10 weeks
|
|
General disorders
Pain
|
10.9%
6/55 • 10 weeks
|
11.3%
6/53 • 10 weeks
|
|
Psychiatric disorders
Insomnia
|
7.3%
4/55 • 10 weeks
|
9.4%
5/53 • 10 weeks
|
|
Psychiatric disorders
Somnolence
|
7.3%
4/55 • 10 weeks
|
7.5%
4/53 • 10 weeks
|
|
Psychiatric disorders
Worsening Psychiatric Symptoms
|
3.6%
2/55 • 10 weeks
|
11.3%
6/53 • 10 weeks
|
|
Nervous system disorders
Headache
|
5.5%
3/55 • 10 weeks
|
7.5%
4/53 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
1.8%
1/55 • 10 weeks
|
11.3%
6/53 • 10 weeks
|
|
General disorders
Sexual Dysfunction
|
7.3%
4/55 • 10 weeks
|
5.7%
3/53 • 10 weeks
|
|
Nervous system disorders
Dry mouth
|
5.5%
3/55 • 10 weeks
|
5.7%
3/53 • 10 weeks
|
|
General disorders
Influenza-like symptoms
|
1.8%
1/55 • 10 weeks
|
9.4%
5/53 • 10 weeks
|
|
General disorders
Rash
|
3.6%
2/55 • 10 weeks
|
5.7%
3/53 • 10 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place