The placebo capsules are supplied as 950 mg capsules consisting of 475 mg corn oil and 475 mg soy oil. Both DHA and placebo are flavored with sweet orange flavoring and masking agents. Subjects will be instructed to take 2 capsules at breakfast and 2 capsules at dinner (with food). Subjects will take their first dose in the office to assure their ability to swallow the pills. Subjects will be dosed with the placebo for 12 weeks.

The DHASCO capsules are supplied as 950 mg capsules with an effective dose of 500 mg DHA per capsule. Both DHA and placebo are flavored with sweet orange flavoring and masking agents. Subjects will be instructed to take 2 capsules at breakfast and 2 capsules at dinner (with food). Subjects will take their first dose in the office to assure their ability to swallow the pills. Subjects will be dosed with the DHA for 12 weeks.

Concussion

Mild Traumatic Brain Injury

Subjects presenting with a new concussion within 4 days of their initial injury will be identified and screened for eligibility from the investigators' regularly scheduled clinic patients. Subjects who enroll will complete 5 scheduled visits, although additional visits may be clinically indicated for symptom evaluation and treatment. All assessments done for this study are routinely done as part of the standard clinic visits for concussion at the Sports Medicine Center. Subjects will be randomized to either DHA or placebo in a 1:1 ratio, and receive enough DHA or placebo capsules to reach the target dose of 2 g of DHA per day (or placebo) until the day of their next appointment. Subjects will be instructed to take 4 capsules (2 at breakfast and 2 at dinner) for 12 weeks.

Docosahexaenoic acid (DHA)

Sports Medicine at Texas Scottish Rite Hospital for Children

DHA For The Treatment of Pediatric Concussion Related to Sports Injury

Docosahexaenoic Acid (DHA) For The Treatment of Pediatric Concussion Related to Sports Injury

Determine the willingness of patients to be randomized, the expected rate of enrollment based on the clinic population, and protocol adherence of enrolled study participants.

Time to clearance to return to play (in days). Time to clearance to return to play was chosen as a clinically significant measurement for medical professionals in the sports medicine field. The investigators will determine clearance for return to full competitive game play (Stage 6 of graduated return to play protocol) according to Consensus Statement guidelines and following the law in Texas, House Bill 2038. Criteria for return to play include complete clinical recovery from the concussion including returning to baseline symptoms, exam and neurocognitive function and successful completion of a gradual return to play progression. We hypothesize that subjects who take 2 g of DHA daily for 3 months will see a shorter time to full recovery and return to play.

Improvement in balance impairment associated with the injury, as assessed by the Balance Error Scoring System (BESS) which is a component of the Sport Concussion Assessment Tool 3 (SCAT-3). We hypothesize a shorter time to resolve balance disturbance associated with the treatment of DHA.

Shane M. Miller, MD

MD, Associate Professor of Orthopaedics and Pediatrics

University of Texas Southwestern Medical Center

Children's Medical Center Dallas

Texas Scottish Rite Hospital for Children

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)

catalase/главобоља

DHA For The Treatment of Pediatric Concussion Related to Sports Injury

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

Најкомплетнија база лековитог биља подржана науком