Bipolar Disorder Clinical Trial
— SMRI-BipolarOfficial title:
A Double-blind Randomized Placebo-controlled Study of Aspirin and N-acetyl Cysteine as Adjunctive Treatments for Bipolar Disorder Patients (SMRI 11T-009)
Verified date | March 2018 |
Source | The University of Texas Health Science Center, Houston |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
We propose to conduct a double-blind placebo-controlled trial with a widely available and
prototypical non-steroidal anti-inflammatory agent, aspirin, and an antioxidant agent, NAC,
involving symptomatic Bipolar Disorder type I and II patients having a depressive or mixed
episode currently. This will be the first controlled study to test the hypothesis that
aspirin and NAC, by themselves or in combination, will be beneficial in treating depression
in bipolar disorder patients and in promoting mood stabilization.
Our study has the following Aims:
Aim I - Examine efficacy of aspirin in treating depression in bipolar patients in a
double-blind placebo-controlled add-on design; Aim II - Examine efficacy of NAC in treating
depression in bipolar patients in a double-blind placebo-controlled add-on design; Aim III -
Examine efficacy of combined treatment with aspirin and NAC looking for synergistic,
potentiating effects; Aim IV - Examine the role of markers of neuroinflammation, as possible
mediators or modulators in therapeutic response in the treatment of depression in patients
with Bipolar Disorder.
Status | Completed |
Enrollment | 38 |
Est. completion date | February 1, 2017 |
Est. primary completion date | February 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Age 18 to 65 years 2. A diagnosis of BD type I or II according to SCID-I interview; 3. Currently in a depressive or mixed episode, based on DSM-IV/ SCID-I criteria; 4. MADRAS >20 at entry in the study; 5. No CURRENT liver, kidney, heart disease or ulcers or bleeding dyscrasia; 6. No HYSTORY of kidney dysfunction or cardiac problems; 7. ON therapeutic doses of a mood stabilizing drug (lithium, anticonvulsants, any atypical antipsychotics) or combinations for at least ONE month. 8. Allowed psychiatric co-morbid conditions, such as anxiety disorders, PTSD and substance use (as long as do NOT meet abuse or dependence criteria according to the SCID-I in the past 2 months). Exclusion Criteria: 1. CANNOT be on any : Anti-inflammatory: NSAIDs: Aspirin (bufferin, bayer aspirin, ecotrin), diflunisal (dolobid, diflunisal),Salsalate (amigesic, salflex), Ibuprofen (motrin, advil), Naproxen (naprosyn,aleve, midol extended relief), Fenoprofen (nalfon), Ketoprofen (actron), dexketoprofen(ketron D), Flurbiprofen (ansaid), Oxaprozin (daypro), Loxoprofen (loxfen, loxonin), Indomethacin (indocin, indocin SR), Sulindac (clinoril), Etodolac (lodine), Ketorolac (toradol), diclofenac (voltaren, cataflam), Nabumetone (Relafen) Piroxicam (feldene), Meloxicam (mobic), Tenoxicam (mobiflex), Lornoxicam (xefo),mefenamic acid (ponstel), meclofenamic acid (meclofenamate sodium), celecoxib (celebrex) Anticoagulants: Coumadin (Warfarin), Heparin Anti-oxidant agents Fish oil NAC ( N-acetyl cysteine) 2. Pregnancy 3. CANNOT change the dose of the psychotropic medications during the trial Women Able to Become Pregnant: Participation in this study may involve risks to an embryo, fetus, or unborn child. If the subject is a female and able to become pregnant, a urine pregnancy test will be performed which must be negative prior to enrolling into the study, and the subject must agree not to become pregnant during the study. Urine pregnancy tests will be performed at Screening visit and week 8. The study staff will review adequate birth control methods with the subject and will remind her that she should not become pregnant during the study. Appropriate methods of birth control include: hormonal contraceptives (such as birth control pills, patches, and implants), barrier methods (such as a condom and diaphragms and spermicidal foam or jelly, surgical (hysterectomy or tubal ligation) or intrauterine device (IUD). The subject will be instructed to notify the study doctor immediately if there is a chance that she has become pregnant. Also, if the subject is breast-feeding an infant or plan on breast-feeding an infant, she must notify the study doctor. It is not known if this drug is excreted in human milk; therefore, breast-feeding is not permitted during the study. Patients can be on any mood stabilizing agents or combinations, as well as on other psychotropic medications at study entry, and the doses of those medications cannot be changed during the trial. They cannot be on any anti-inflammatory or anti-oxidant agents or anticoagulant at the point they are enrolled. If patients decompensate significantly, and/or become acutely suicidal, participation on the trial will be terminated. |
Country | Name | City | State |
---|---|---|---|
United States | UT Center of Excellence on Mood Disorders | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston | Stanley Medical Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Received drug for 8 weeks during week 0 to week 8 of the study | |
Primary | 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. | Received drug for 8 weeks during week 9 to week 16 of the study | |
Primary | Number of Patients Demonstrating a > 30% 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. | Received drug for 8 weeks during week 0 to week 8 of the study | |
Primary | Number of Patients Demonstrating a > 30% 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. | Received drug for 8 weeks during week 9 to week 16 of the study | |
Secondary | Inflammation as Indicated by C-reactive Protein (CRP) Levels | 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. | baseline, week 8, week 16 | |
Secondary | Inflammation as Indicated by Interleukin 6 (IL-6) 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. | baseline, week 8, week 16 | |
Secondary | Inflammation as Indicated by Soluble Interleukin-2 (IL-2) Receptor Levels | baseline, week 8, week 16 | ||
Secondary | Inflammation as Indicated by Tumor Necrosis Factor (TNF)-Alpha Levels | baseline, week 8, week 16 | ||
Secondary | Oxidative Stress as Indicated by Superoxide Dismutase Activity | baseline, week 8, week 16 | ||
Secondary | Oxidative Stress as Indicated by Catalase Activity | baseline, week 8, week 16 | ||
Secondary | Oxidative Stress as Indicated by Serum Thiobarbituric Acid Reactive Substances (TBARS) Levels | baseline, week 8, week 16 |
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