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N-Acetyl Cysteine and Aspirin as an Adjunctive Treatment for Bipolar Disorder (SMRI-Bipolar)

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ClinicalTrials.gov Identifier: NCT01797575
Recruitment Status : Completed
First Posted : February 22, 2013
Results First Posted : April 30, 2018
Last Update Posted : April 30, 2018
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Jair Soares, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Bipolar Disorder
Interventions Drug: Aspirin
Dietary Supplement: N-acetyl-cysteine (NAC)
Drug: Sugar Pill
Enrollment 38
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Aspirin N-acetyl-cysteine Aspirin and NAC Sugar Pill
Hide Arm/Group Description

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

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

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

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

Period Title: Baseline Allocation
Started 5 9 9 15
Completed 4 8 4 8
Not Completed 1 1 5 7
Period Title: Week 8 Re-Randomization
Started [1] 4 [1] 5 [1] 5 [1] 10 [1]
Completed 4 5 4 7
Not Completed 0 0 1 3
[1]
Non-responders during Period 1 were re-randomized at week 8 into a new treatment arm.
Arm/Group Title Aspirin N-acetyl-cysteine Aspirin and NAC Sugar Pill Total
Hide Arm/Group Description

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

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

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

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 of all reporting groups
Overall Number of Baseline Participants 4 8 4 8 24
Hide Baseline Analysis Population Description
Baseline characteristics are reported using arm assignment for completers of period one. Patients were randomly assigned to one of four arms during period one, weeks 0-8. Patients who did not respond in period one were re-randomized during period two. Overall Number includes those withdrawn prior to week 8, so it is larger than the number analyzed.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 8 participants 4 participants 8 participants 24 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
8
 100.0%
4
 100.0%
8
 100.0%
24
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 8 participants 4 participants 8 participants 24 participants
49  (15.21) 36.38  (7.05) 40  (17.64) 39.13  (9.99) 40.56  (11.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 8 participants 4 participants 8 participants 24 participants
Female
3
  75.0%
5
  62.5%
1
  25.0%
6
  75.0%
15
  62.5%
Male
1
  25.0%
3
  37.5%
3
  75.0%
2
  25.0%
9
  37.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 8 participants 4 participants 8 participants 24 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
2
  50.0%
2
  25.0%
4
  16.7%
Not Hispanic or Latino
4
 100.0%
7
  87.5%
2
  50.0%
6
  75.0%
19
  79.2%
Unknown or Not Reported
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
1
   4.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 8 participants 4 participants 8 participants 24 participants
American Indian or Alaska Native
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
1
   4.2%
Asian
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  25.0%
1
  12.5%
0
   0.0%
1
  12.5%
3
  12.5%
White
2
  50.0%
5
  62.5%
4
 100.0%
6
  75.0%
17
  70.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
1
   4.2%
Unknown or Not Reported
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
1
   4.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 8 participants 4 participants 8 participants 24 participants
4 8 4 8 24
MADRS Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 4 participants 8 participants 4 participants 8 participants 24 participants
22.5  (10.47) 19.38  (4.87) 19.5  (1) 22.88  (4.09) 21.08  (5.45)
[1]
Measure Description: The Montgomery–Åsberg Depression Rating Scale (MADRS) is a 10 item instrument with an overall score ranging from 0 to 54 points. A higher score corresponds with more severe depressive illness.
YMRS Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 4 participants 8 participants 4 participants 8 participants 24 participants
4  (5.42) 5.5  (3.46) 5.75  (4.27) 4.38  (4.63) 4.92  (4.11)
[1]
Measure Description: The Young Mania Rating Scale (YMRS) is an 11 item instrument with an overall score ranging from 0 to 60 points. A higher score corresponds with more severe manic illness.
1.Primary Outcome
Title Number of Patients Demonstrating a > 50% Decrease in Depression Scores on the Montgomery–Åsberg Depression Rating Scale (MADRS)
Hide Description 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.
Time Frame Received drug for 8 weeks during week 0 to week 8 of the study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin and NAC Aspirin N-Acetyl Cysteine (NAC) Placebo
Hide Arm/Group Description:

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

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

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.)
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
Overall Number of Participants Analyzed 4 4 8 8
Measure Type: Count of Participants
Unit of Measure: Participants
3
  75.0%
2
  50.0%
5
  62.5%
6
  75.0%
2.Primary Outcome
Title Number of Patients Demonstrating a > 50% Decrease in Depression Scores on the Montgomery–Åsberg Depression Rating Scale (MADRS)
Hide Description 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.
Time Frame Received drug for 8 weeks during week 9 to week 16 of the study
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Aspirin and NAC Aspirin N-Acetyl Cysteine (NAC) Placebo
Hide Arm/Group Description:

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

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

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.)
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
Overall Number of Participants Analyzed 4 4 5 7
Measure Type: Count of Participants
Unit of Measure: Participants
3
  75.0%
1
  25.0%
3
  60.0%
4
  57.1%
3.Primary Outcome
Title Number of Patients Demonstrating a > 30% Decrease in Depression Scores on the Montgomery–Åsberg Depression Rating Scale (MADRS)
Hide Description 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.
Time Frame Received drug for 8 weeks during week 0 to week 8 of the study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin and NAC Aspirin N-Acetyl Cysteine (NAC) Placebo
Hide Arm/Group Description:

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

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

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.)
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
Overall Number of Participants Analyzed 4 4 8 8
Measure Type: Count of Participants
Unit of Measure: Participants
3
  75.0%
2
  50.0%
6
  75.0%
7
  87.5%
4.Primary Outcome
Title Number of Patients Demonstrating a > 30% Decrease in Depression Scores on the Montgomery–Åsberg Depression Rating Scale (MADRS)
Hide Description 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.
Time Frame Received drug for 8 weeks during week 9 to week 16 of the study
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Aspirin and NAC Aspirin N-Acetyl Cysteine (NAC) Placebo
Hide Arm/Group Description:

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

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

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.)
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
Overall Number of Participants Analyzed 4 4 5 7
Measure Type: Count of Participants
Unit of Measure: Participants
4
 100.0%
3
  75.0%
3
  60.0%
4
  57.1%
5.Secondary Outcome
Title Inflammation as Indicated by C-reactive Protein (CRP) Levels
Hide Description 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.
Time Frame baseline, week 8, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Aspirin N-acetyl-cysteine Aspirin and NAC Sugar Pill
Hide Arm/Group Description:

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

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

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

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

Overall Number of Participants Analyzed 3 7 3 6
Mean (Standard Deviation)
Unit of Measure: milligrams per liter
CRP at Baseline Number Analyzed 3 participants 7 participants 3 participants 6 participants
6.85  (4.72) 17.65  (13.51) 5.1  (2.86) 17.30  (20.74)
CRP at Week 8 Number Analyzed 3 participants 1 participants 2 participants 5 participants
6.82  (8.4) 41.09  (0) 17.02  (9.21) 7.4  (6.1)
CRP at Week 16 Number Analyzed 3 participants 6 participants 2 participants 6 participants
10.76  (11.29) 17.69  (10.98) 9.39  (7.05) 13.10  (17.98)
6.Secondary Outcome
Title Inflammation as Indicated by Interleukin 6 (IL-6) Levels
Hide Description 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.
Time Frame baseline, week 8, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Aspirin N-acetyl-cysteine Aspirin and NAC Sugar Pill
Hide Arm/Group Description:

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

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

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

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

Overall Number of Participants Analyzed 3 7 3 6
Mean (Standard Deviation)
Unit of Measure: picograms per milliliter
IL-6 at Baseline Number Analyzed 3 participants 7 participants 3 participants 6 participants
1.27  (.83) 3.22  (2.02) .85  (.79) 2.3  (1.47)
IL-6 at Week 8 Number Analyzed 3 participants 1 participants 2 participants 5 participants
.78  (.43) 3.53  (0) 1.76  (.64) 1.87  (.55)
IL-6 at Week 16 Number Analyzed 3 participants 6 participants 2 participants 6 participants
.90  (.57) 2.6  (1.84) 1.72  (1.15) 1.71  (1.11)
7.Secondary Outcome
Title Inflammation as Indicated by Soluble Interleukin-2 (IL-2) Receptor Levels
Hide Description [Not Specified]
Time Frame baseline, week 8, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome measure. Blood samples were collected from participants, but tests for this particular outcome measure were not completed.
Arm/Group Title Aspirin N-acetyl-cysteine Aspirin and NAC Sugar Pill
Hide Arm/Group Description:

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

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

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

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

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Inflammation as Indicated by Tumor Necrosis Factor (TNF)-Alpha Levels
Hide Description [Not Specified]
Time Frame baseline, week 8, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome measure. Blood samples were collected from participants, but tests for this particular outcome measure were not completed.
Arm/Group Title Aspirin N-acetyl-cysteine Aspirin and NAC Sugar Pill
Hide Arm/Group Description:

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

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

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

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

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Oxidative Stress as Indicated by Superoxide Dismutase Activity
Hide Description [Not Specified]
Time Frame baseline, week 8, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome measure. Blood samples were collected from participants, but tests for this particular outcome measure were not completed.
Arm/Group Title Aspirin N-acetyl-cysteine Aspirin and NAC Sugar Pill
Hide Arm/Group Description:

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

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

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

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

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Oxidative Stress as Indicated by Catalase Activity
Hide Description [Not Specified]
Time Frame baseline, week 8, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome measure. Blood samples were collected from participants, but tests for this particular outcome measure were not completed.
Arm/Group Title Aspirin N-acetyl-cysteine Aspirin and NAC Sugar Pill
Hide Arm/Group Description:

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

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

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

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

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Oxidative Stress as Indicated by Serum Thiobarbituric Acid Reactive Substances (TBARS) Levels
Hide Description [Not Specified]
Time Frame baseline, week 8, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome measure. Blood samples were collected from participants, but tests for this particular outcome measure were not completed.
Arm/Group Title Aspirin N-acetyl-cysteine Aspirin and NAC Sugar Pill
Hide Arm/Group Description:

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

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

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

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

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event data was collected during study participation - 16 weeks or until participants withdrew from the study.
Adverse Event Reporting Description 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.
 
Arm/Group Title Aspirin N-acetyl-cysteine Aspirin and NAC Sugar Pill
Hide Arm/Group Description

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

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

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

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

All-Cause Mortality
Aspirin N-acetyl-cysteine Aspirin and NAC Sugar Pill
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)      0/14 (0.00%)      0/14 (0.00%)      0/25 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Aspirin N-acetyl-cysteine Aspirin and NAC Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/14 (0.00%)      1/14 (7.14%)      1/25 (4.00%)    
Psychiatric disorders         
Hospitalization  [1]  0/9 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 1/25 (4.00%)  1
Hospitalization  [2]  0/9 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/25 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Depression/Suicidal Ideations
[2]
Manic Episode of Bipolar I Disorder
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aspirin N-acetyl-cysteine Aspirin and NAC Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/9 (11.11%)      0/14 (0.00%)      1/14 (7.14%)      1/25 (4.00%)    
Pregnancy, puerperium and perinatal conditions         
Positive Pregnancy Test  [1]  0/9 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/25 (0.00%)  0
Skin and subcutaneous tissue disorders         
Skin Irritation  1 [2]  1/9 (11.11%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0 1/25 (4.00%)  1
1
Term from vocabulary, Skin Irritation
Indicates events were collected by systematic assessment
[1]
Positive pregnancy test at final study visit. All preceding pregnancy tests were negative throughout the study visits.
[2]
Skin Irritation / Rash - Experience by a patient (determined likely due to citrus allergy) who was re-randomized after week 8. the same patient experienced the rash while taking Aspirin and then while on Placebo.
Mild to moderately severe depressive symptoms at baseline (therapeutic effects of NAC and Aspirin would have been different in more depressed sample). Small sample size (findings lack the required precision in estimates of effect).
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
Name/Title: Jair C Soares, MD
Organization: The University of Texas Health Science Center at Houston
Phone: 713-486-2627
Responsible Party: Jair Soares, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01797575     History of Changes
Other Study ID Numbers: HSC-MS-12-0046
SMRI ( Other Grant/Funding Number: The Stanley Medical Research Institute )
SMRI#11T-009 ( Other Grant/Funding Number: The Stanley Medical Research Institute )
First Submitted: June 8, 2012
First Posted: February 22, 2013
Results First Submitted: February 1, 2018
Results First Posted: April 30, 2018
Last Update Posted: April 30, 2018