Trial Outcomes & Findings for N-Acetyl Cysteine and Aspirin as an Adjunctive Treatment for Bipolar Disorder (NCT NCT01797575)
NCT ID: NCT01797575
Last Updated: 2018-04-30
Results Overview
The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms: 1. Apparent sadness; 2. Reported sadness; 3. Inner tension; 4. Reduced sleep; 5. Reduced appetite; 6. Concentration difficulties; 7. Lassitude; 8. Inability to feel; 9. Pessimistic thoughts; and 10. Suicidal thoughts.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
Received drug for 8 weeks during week 0 to week 8 of the study
Results posted on
2018-04-30
Participant Flow
Patients were randomly assigned to one of the four arms during weeks 0-8. For patients who did not respond to treatment in period one, they were re-randomized to one of the other three arms and received a drug they had not yet received during period one. 8 were re-randomized to a different arm during period two.
Participant milestones
| Measure |
Aspirin
research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations
Aspirin: aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine
|
N-acetyl-cysteine
research subject will be taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations
N-acetyl-cysteine (NAC): taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine
|
Aspirin and NAC
research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations.
Aspirin and NAC: aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine
|
Sugar Pill
research subject will be taking 4 capsules of matching sugar pill( placebo) in the morning and 2 capsules of matching placebo in the evenings in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations
Sugar Pill: research subject will be taking placebo in addition to his/her antidepressant and/or mood stabilizer medicine
|
|---|---|---|---|---|
|
Baseline Allocation
STARTED
|
5
|
9
|
9
|
15
|
|
Baseline Allocation
COMPLETED
|
4
|
8
|
4
|
8
|
|
Baseline Allocation
NOT COMPLETED
|
1
|
1
|
5
|
7
|
|
Week 8 Re-Randomization
STARTED
|
4
|
5
|
5
|
10
|
|
Week 8 Re-Randomization
COMPLETED
|
4
|
5
|
4
|
7
|
|
Week 8 Re-Randomization
NOT COMPLETED
|
0
|
0
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
N-Acetyl Cysteine and Aspirin as an Adjunctive Treatment for Bipolar Disorder
Baseline characteristics by cohort
| Measure |
Aspirin
n=4 Participants
research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations
Aspirin: aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine
|
N-acetyl-cysteine
n=8 Participants
research subject will be taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations
N-acetyl-cysteine (NAC): taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine
|
Aspirin and NAC
n=4 Participants
research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations.
Aspirin and NAC: aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine
|
Sugar Pill
n=8 Participants
research subject will be taking 4 capsules of matching sugar pill( placebo) in the morning and 2 capsules of matching placebo in the evenings in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations
Sugar Pill: research subject will be taking placebo in addition to his/her antidepressant and/or mood stabilizer medicine
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
24 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 15.21 • n=93 Participants
|
36.38 years
STANDARD_DEVIATION 7.05 • n=4 Participants
|
40 years
STANDARD_DEVIATION 17.64 • n=27 Participants
|
39.13 years
STANDARD_DEVIATION 9.99 • n=483 Participants
|
40.56 years
STANDARD_DEVIATION 11.72 • n=36 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
15 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
19 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
17 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=93 Participants
|
8 participants
n=4 Participants
|
4 participants
n=27 Participants
|
8 participants
n=483 Participants
|
24 participants
n=36 Participants
|
|
MADRS Total Score
|
22.5 units on a scale
STANDARD_DEVIATION 10.47 • n=93 Participants
|
19.38 units on a scale
STANDARD_DEVIATION 4.87 • n=4 Participants
|
19.5 units on a scale
STANDARD_DEVIATION 1 • n=27 Participants
|
22.88 units on a scale
STANDARD_DEVIATION 4.09 • n=483 Participants
|
21.08 units on a scale
STANDARD_DEVIATION 5.45 • n=36 Participants
|
|
YMRS Total Score
|
4 units on a scale
STANDARD_DEVIATION 5.42 • n=93 Participants
|
5.5 units on a scale
STANDARD_DEVIATION 3.46 • n=4 Participants
|
5.75 units on a scale
STANDARD_DEVIATION 4.27 • n=27 Participants
|
4.38 units on a scale
STANDARD_DEVIATION 4.63 • n=483 Participants
|
4.92 units on a scale
STANDARD_DEVIATION 4.11 • n=36 Participants
|
PRIMARY outcome
Timeframe: Received drug for 8 weeks during week 0 to week 8 of the studyThe MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms: 1. Apparent sadness; 2. Reported sadness; 3. Inner tension; 4. Reduced sleep; 5. Reduced appetite; 6. Concentration difficulties; 7. Lassitude; 8. Inability to feel; 9. Pessimistic thoughts; and 10. Suicidal thoughts.
Outcome measures
| Measure |
Aspirin and NAC
n=4 Participants
research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations.
Aspirin and NAC: aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine
|
Aspirin
n=4 Participants
research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations
Aspirin: aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine
|
N-Acetyl Cysteine (NAC)
n=8 Participants
Examine efficacy of NAC in treating depression in bipolar patients in a double-blind placebo-controlled add-on design. Proportion of patients demonstrating \> 50% decrease in depression scores on the MADRS, as a Function of Treatment (on NAC treatment only). (We completed follow-up analyses with a 30% MADRS improvement criterion due to our limited sample size compared to original goals, as we fell short on patient recruitment goals and ended up with a somewhat underpowered study.)
|
Placebo
n=8 Participants
research subject will be taking 4 capsules of matching sugar pill( placebo) in the morning and 2 capsules of matching placebo in the evenings in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations
|
|---|---|---|---|---|
|
Number of Patients Demonstrating a > 50% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS)
|
3 Participants
|
2 Participants
|
5 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Received drug for 8 weeks during week 9 to week 16 of the studyPopulation: Patients who responded to treatment during week 0-8 were maintained on current treatment. Patients who did no respond were re-randomized for week 9-16.
The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms: 1. Apparent sadness; 2. Reported sadness; 3. Inner tension; 4. Reduced sleep; 5. Reduced appetite; 6. Concentration difficulties; 7. Lassitude; 8. Inability to feel; 9. Pessimistic thoughts; and 10. Suicidal thoughts.
Outcome measures
| Measure |
Aspirin and NAC
n=4 Participants
research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations.
Aspirin and NAC: aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine
|
Aspirin
n=4 Participants
research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations
Aspirin: aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine
|
N-Acetyl Cysteine (NAC)
n=5 Participants
Examine efficacy of NAC in treating depression in bipolar patients in a double-blind placebo-controlled add-on design. Proportion of patients demonstrating \> 50% decrease in depression scores on the MADRS, as a Function of Treatment (on NAC treatment only). (We completed follow-up analyses with a 30% MADRS improvement criterion due to our limited sample size compared to original goals, as we fell short on patient recruitment goals and ended up with a somewhat underpowered study.)
|
Placebo
n=7 Participants
research subject will be taking 4 capsules of matching sugar pill( placebo) in the morning and 2 capsules of matching placebo in the evenings in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations
|
|---|---|---|---|---|
|
Number of Patients Demonstrating a > 50% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS)
|
3 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Received drug for 8 weeks during week 0 to week 8 of the studyThe MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms: 1. Apparent sadness; 2. Reported sadness; 3. Inner tension; 4. Reduced sleep; 5. Reduced appetite; 6. Concentration difficulties; 7. Lassitude; 8. Inability to feel; 9. Pessimistic thoughts; and 10. Suicidal thoughts. This 30% MADRS reduction was analyzed in addition to initial outcome measures of 50% MADRS reduction due to the smaller than expected study sample size.
Outcome measures
| Measure |
Aspirin and NAC
n=4 Participants
research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations.
Aspirin and NAC: aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine
|
Aspirin
n=4 Participants
research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations
Aspirin: aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine
|
N-Acetyl Cysteine (NAC)
n=8 Participants
Examine efficacy of NAC in treating depression in bipolar patients in a double-blind placebo-controlled add-on design. Proportion of patients demonstrating \> 50% decrease in depression scores on the MADRS, as a Function of Treatment (on NAC treatment only). (We completed follow-up analyses with a 30% MADRS improvement criterion due to our limited sample size compared to original goals, as we fell short on patient recruitment goals and ended up with a somewhat underpowered study.)
|
Placebo
n=8 Participants
research subject will be taking 4 capsules of matching sugar pill( placebo) in the morning and 2 capsules of matching placebo in the evenings in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations
|
|---|---|---|---|---|
|
Number of Patients Demonstrating a > 30% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS)
|
3 Participants
|
2 Participants
|
6 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Received drug for 8 weeks during week 9 to week 16 of the studyPopulation: Patients who responded to treatment during week 0-8 were maintained on current treatment. Patients who did no respond were re-randomized for week 9-16.
The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms: 1. Apparent sadness; 2. Reported sadness; 3. Inner tension; 4. Reduced sleep; 5. Reduced appetite; 6. Concentration difficulties; 7. Lassitude; 8. Inability to feel; 9. Pessimistic thoughts; and 10. Suicidal thoughts. This 30% MADRS reduction was analyzed in addition to initial outcome measures of 50% MADRS reduction due to the smaller than expected study sample size.
Outcome measures
| Measure |
Aspirin and NAC
n=4 Participants
research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations.
Aspirin and NAC: aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine
|
Aspirin
n=4 Participants
research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations
Aspirin: aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine
|
N-Acetyl Cysteine (NAC)
n=5 Participants
Examine efficacy of NAC in treating depression in bipolar patients in a double-blind placebo-controlled add-on design. Proportion of patients demonstrating \> 50% decrease in depression scores on the MADRS, as a Function of Treatment (on NAC treatment only). (We completed follow-up analyses with a 30% MADRS improvement criterion due to our limited sample size compared to original goals, as we fell short on patient recruitment goals and ended up with a somewhat underpowered study.)
|
Placebo
n=7 Participants
research subject will be taking 4 capsules of matching sugar pill( placebo) in the morning and 2 capsules of matching placebo in the evenings in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations
|
|---|---|---|---|---|
|
Number of Patients Demonstrating a > 30% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS)
|
4 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: baseline, week 8, week 16Population: Row numbers differ from overall number analyzed either due to patient withdrawal from study prior to completion, or from failure to obtain a blood sample from patient during study. Overall number analyzed differs from overall number of baseline participants for the same reason.
C-reactive protein (CRP) levels are blood test markers of inflammation. Higher CRP corresponds with higher levels of inflammation. CRP is measured in milligrams per liter.
Outcome measures
| Measure |
Aspirin and NAC
n=3 Participants
research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations.
Aspirin and NAC: aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine
|
Aspirin
n=7 Participants
research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations
Aspirin: aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine
|
N-Acetyl Cysteine (NAC)
n=3 Participants
Examine efficacy of NAC in treating depression in bipolar patients in a double-blind placebo-controlled add-on design. Proportion of patients demonstrating \> 50% decrease in depression scores on the MADRS, as a Function of Treatment (on NAC treatment only). (We completed follow-up analyses with a 30% MADRS improvement criterion due to our limited sample size compared to original goals, as we fell short on patient recruitment goals and ended up with a somewhat underpowered study.)
|
Placebo
n=6 Participants
research subject will be taking 4 capsules of matching sugar pill( placebo) in the morning and 2 capsules of matching placebo in the evenings in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations
|
|---|---|---|---|---|
|
Inflammation as Indicated by C-reactive Protein (CRP) Levels
CRP at Week 8
|
6.82 milligrams per liter
Standard Deviation 8.4
|
41.09 milligrams per liter
Standard Deviation 0
|
17.02 milligrams per liter
Standard Deviation 9.21
|
7.4 milligrams per liter
Standard Deviation 6.1
|
|
Inflammation as Indicated by C-reactive Protein (CRP) Levels
CRP at Week 16
|
10.76 milligrams per liter
Standard Deviation 11.29
|
17.69 milligrams per liter
Standard Deviation 10.98
|
9.39 milligrams per liter
Standard Deviation 7.05
|
13.10 milligrams per liter
Standard Deviation 17.98
|
|
Inflammation as Indicated by C-reactive Protein (CRP) Levels
CRP at Baseline
|
6.85 milligrams per liter
Standard Deviation 4.72
|
17.65 milligrams per liter
Standard Deviation 13.51
|
5.1 milligrams per liter
Standard Deviation 2.86
|
17.30 milligrams per liter
Standard Deviation 20.74
|
SECONDARY outcome
Timeframe: baseline, week 8, week 16Population: Row numbers differ from overall number analyzed either due to patient withdrawal from study prior to completion, or from failure to obtain a blood sample from patient during study. Overall number analyzed differs from overall number of baseline participants for the same reason.
Interleukin 6 (IL-6) is an interleukin that acts as a pro-inflammatory cytokine and an anti-inflammatory myokine. IL-6 is measured in picograms (pg) per milliliter (mL). Elevated interleukin-6 indicates potential immune system dysregulation and increased inflammation.
Outcome measures
| Measure |
Aspirin and NAC
n=3 Participants
research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations.
Aspirin and NAC: aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine
|
Aspirin
n=7 Participants
research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations
Aspirin: aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine
|
N-Acetyl Cysteine (NAC)
n=3 Participants
Examine efficacy of NAC in treating depression in bipolar patients in a double-blind placebo-controlled add-on design. Proportion of patients demonstrating \> 50% decrease in depression scores on the MADRS, as a Function of Treatment (on NAC treatment only). (We completed follow-up analyses with a 30% MADRS improvement criterion due to our limited sample size compared to original goals, as we fell short on patient recruitment goals and ended up with a somewhat underpowered study.)
|
Placebo
n=6 Participants
research subject will be taking 4 capsules of matching sugar pill( placebo) in the morning and 2 capsules of matching placebo in the evenings in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations
|
|---|---|---|---|---|
|
Inflammation as Indicated by Interleukin 6 (IL-6) Levels
IL-6 at Baseline
|
1.27 picograms per milliliter
Standard Deviation .83
|
3.22 picograms per milliliter
Standard Deviation 2.02
|
.85 picograms per milliliter
Standard Deviation .79
|
2.3 picograms per milliliter
Standard Deviation 1.47
|
|
Inflammation as Indicated by Interleukin 6 (IL-6) Levels
IL-6 at Week 8
|
.78 picograms per milliliter
Standard Deviation .43
|
3.53 picograms per milliliter
Standard Deviation 0
|
1.76 picograms per milliliter
Standard Deviation .64
|
1.87 picograms per milliliter
Standard Deviation .55
|
|
Inflammation as Indicated by Interleukin 6 (IL-6) Levels
IL-6 at Week 16
|
.90 picograms per milliliter
Standard Deviation .57
|
2.6 picograms per milliliter
Standard Deviation 1.84
|
1.72 picograms per milliliter
Standard Deviation 1.15
|
1.71 picograms per milliliter
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: baseline, week 8, week 16Population: Data was not collected for this outcome measure. Blood samples were collected from participants, but tests for this particular outcome measure were not completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, week 8, week 16Population: Data was not collected for this outcome measure. Blood samples were collected from participants, but tests for this particular outcome measure were not completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, week 8, week 16Population: Data was not collected for this outcome measure. Blood samples were collected from participants, but tests for this particular outcome measure were not completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, week 8, week 16Population: Data was not collected for this outcome measure. Blood samples were collected from participants, but tests for this particular outcome measure were not completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, week 8, week 16Population: Data was not collected for this outcome measure. Blood samples were collected from participants, but tests for this particular outcome measure were not completed.
Outcome measures
Outcome data not reported
Adverse Events
Aspirin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
N-acetyl-cysteine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aspirin and NAC
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Sugar Pill
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aspirin
n=9 participants at risk
research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations
Aspirin: aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine
|
N-acetyl-cysteine
n=14 participants at risk
research subject will be taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations
N-acetyl-cysteine (NAC): taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine
|
Aspirin and NAC
n=14 participants at risk
research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations.
Aspirin and NAC: aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine
|
Sugar Pill
n=25 participants at risk
research subject will be taking 4 capsules of matching sugar pill( placebo) in the morning and 2 capsules of matching placebo in the evenings in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations
Sugar Pill: research subject will be taking placebo in addition to his/her antidepressant and/or mood stabilizer medicine
|
|---|---|---|---|---|
|
Psychiatric disorders
Hospitalization
|
0.00%
0/9 • Adverse event data was collected during study participation - 16 weeks or until participants withdrew from the study.
The number at risk for each arm includes the number at risk during week 0 to week 8 plus the number at risk during week 9 to week 16.
|
0.00%
0/14 • Adverse event data was collected during study participation - 16 weeks or until participants withdrew from the study.
The number at risk for each arm includes the number at risk during week 0 to week 8 plus the number at risk during week 9 to week 16.
|
7.1%
1/14 • Number of events 1 • Adverse event data was collected during study participation - 16 weeks or until participants withdrew from the study.
The number at risk for each arm includes the number at risk during week 0 to week 8 plus the number at risk during week 9 to week 16.
|
0.00%
0/25 • Adverse event data was collected during study participation - 16 weeks or until participants withdrew from the study.
The number at risk for each arm includes the number at risk during week 0 to week 8 plus the number at risk during week 9 to week 16.
|
Other adverse events
| Measure |
Aspirin
n=9 participants at risk
research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations
Aspirin: aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine
|
N-acetyl-cysteine
n=14 participants at risk
research subject will be taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations
N-acetyl-cysteine (NAC): taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine
|
Aspirin and NAC
n=14 participants at risk
research subject will be taking aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations.
Aspirin and NAC: aspirin 1000mg (2 capsules of 500mg) every morning and NAC 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine
|
Sugar Pill
n=25 participants at risk
research subject will be taking 4 capsules of matching sugar pill( placebo) in the morning and 2 capsules of matching placebo in the evenings in addition to his/her mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations
Sugar Pill: research subject will be taking placebo in addition to his/her antidepressant and/or mood stabilizer medicine
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Positive Pregnancy Test
|
0.00%
0/9 • Adverse event data was collected during study participation - 16 weeks or until participants withdrew from the study.
The number at risk for each arm includes the number at risk during week 0 to week 8 plus the number at risk during week 9 to week 16.
|
0.00%
0/14 • Adverse event data was collected during study participation - 16 weeks or until participants withdrew from the study.
The number at risk for each arm includes the number at risk during week 0 to week 8 plus the number at risk during week 9 to week 16.
|
7.1%
1/14 • Number of events 1 • Adverse event data was collected during study participation - 16 weeks or until participants withdrew from the study.
The number at risk for each arm includes the number at risk during week 0 to week 8 plus the number at risk during week 9 to week 16.
|
0.00%
0/25 • Adverse event data was collected during study participation - 16 weeks or until participants withdrew from the study.
The number at risk for each arm includes the number at risk during week 0 to week 8 plus the number at risk during week 9 to week 16.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected during study participation - 16 weeks or until participants withdrew from the study.
The number at risk for each arm includes the number at risk during week 0 to week 8 plus the number at risk during week 9 to week 16.
|
0.00%
0/14 • Adverse event data was collected during study participation - 16 weeks or until participants withdrew from the study.
The number at risk for each arm includes the number at risk during week 0 to week 8 plus the number at risk during week 9 to week 16.
|
0.00%
0/14 • Adverse event data was collected during study participation - 16 weeks or until participants withdrew from the study.
The number at risk for each arm includes the number at risk during week 0 to week 8 plus the number at risk during week 9 to week 16.
|
4.0%
1/25 • Number of events 1 • Adverse event data was collected during study participation - 16 weeks or until participants withdrew from the study.
The number at risk for each arm includes the number at risk during week 0 to week 8 plus the number at risk during week 9 to week 16.
|
Additional Information
Jair C Soares, MD
The University of Texas Health Science Center at Houston
Phone: 713-486-2627
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place