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

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

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.

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

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

Aspirin

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

N-acetyl-cysteine

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 and NAC

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

Sugar Pill

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

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.

MADRS Total Score

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.

YMRS Total Score

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.

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.)

N-Acetyl Cysteine (NAC)

Placebo

Number of Patients Demonstrating a > 50% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS)

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.

Number of Patients Demonstrating a > 30% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS)

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.

Inflammation as Indicated by C-reactive Protein (CRP) Levels

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.

Inflammation as Indicated by Interleukin 6 (IL-6) Levels

Inflammation as Indicated by Soluble Interleukin-2 (IL-2) Receptor Levels

Inflammation as Indicated by Tumor Necrosis Factor (TNF)-Alpha Levels

Oxidative Stress as Indicated by Superoxide Dismutase Activity

Oxidative Stress as Indicated by Catalase Activity

Oxidative Stress as Indicated by Serum Thiobarbituric Acid Reactive Substances (TBARS) Levels

Baseline Allocation

Week 8 Re-Randomization

Jair C Soares, MD

Bipolar Disorder

aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine

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

N-acetyl-cysteine (NAC)

research subject will be taking placebo in addition to his/her antidepressant and/or mood stabilizer medicine

UT Center of Excellence on Mood Disorders at Houston

UT Center of Excellence on Mood Disorders

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

A Double-blind Randomized Placebo-controlled Study of Aspirin and N-acetyl Cysteine as Adjunctive Treatments for Bipolar Disorder Patients (SMRI 11T-009)

Jair Soares

Professor & Chairman - PSY-Behavioral Sciences

The University of Texas Health Science Center, Houston

Stanley Medical Research Institute

lansoprazole : 30 mg of lansoprazole twice daily for 6 weeks

Lansoprazole

placebo comparator to lansoprazole 30 mg twice daily for 6 weeks

Change in mean lymphocyte count in bronchus intermedius biopsies between lansoprazole and placebo groups, measured in lymphocytes per square millimeter. Overall mean differences were compared (post-intervention mean lymphocyte count minus pre-intervention mean lymphocyte count) between the two intervention groups.

lansoprazole: 30 mg lansoprazole twice daily for 6 weeks

placebo comparator to lansoprazole 30 mg, twice daily for 6 weeks

Change in Lymphocyte Count

Change in TNF alpha cytokine expression from bronchoalveolar lavage aspirate samples between lansoprazole and placebo groups, measured in log picograms per milliliter (log (pg/mL)) units, pre- and post-intervention.

Log Change in Tumor Necrosis Factor (TNF) Alpha Measurement

placebo comparator to lansoprazole, 30 mg, twice a day for 6 weeks

Overall Study

kathryn peterson

Gastroesophageal Reflux

Asthma

30 mg of lansoprazole twice daily for 6 weeks

heartburn/nécrose

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

Elucidation of Acid-Induced Pulmonary Inflammation

Immunologic Factors in Reflux Esophagitis and Barrett's Esophagus

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