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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by The University of Texas Health Science Center, Houston
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Jair Soares, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01797575
First received: June 8, 2012
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Drug: Asprin
Dietary Supplement: N-acetyl-cysteine (NAC)
Drug: Asprin and NAC
Drug: Sugar Pill
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind Randomized Placebo-controlled Study of Aspirin and N-acetyl Cysteine as Adjunctive Treatments for Bipolar Disorder Patients (SMRI 11T-009)

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Proportion of patients demonstrating > 50% decrease in depression scores on the MADRS, as a function of treatment (on aspirin treatment only). [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Examine efficacy of aspirin in treating depression in bipolar patients in a double-blind placebo-controlled add-on design;


Secondary Outcome Measures:
  • Modulators of therapeutic response [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Examine the role of markers of neuroinflammation, oxidative stress and cytokines as possible mediators or modulators in therapeutic response in the treatment of depression in patients with Bipolar Disorder

  • Proportion of patients demonstrating > 50% decrease in depression scores on the [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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/Aspirin combination treatment). [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Examine efficacy of NAC/Aspirin combination in treating depression in bipolar patients in a double-blind placebo-controlled add-on design.


Estimated Enrollment: 160
Study Start Date: January 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Asprin
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
Drug: Asprin
aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine
Other Names:
  • Ecotrin
  • Bayer Aspirin
  • Bufferin
  • Acetylsalicylic Acid
Active Comparator: 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
Dietary Supplement: 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
Other Names:
  • Acetylcysteine
  • N-Acetyl Cysteine
  • NAC
Active Comparator: Asprin 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.
Drug: Asprin 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
Other Names:
  • Ecotrin
  • Bayer Aspirin
  • Bufferin
  • Acetylsalicylic Acid
  • +
  • Acetylcysteine
  • N- Acetyl Cysteine
  • NAC
Placebo Comparator: 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
Drug: Sugar Pill
research subject will be taking placebo in addition to his/her antidepressant and/or mood stabilizer medicine
Other Name: Sugar pill

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01797575

Contacts
Contact: Jair Soares, MD +1 (713) 486-2627 utmooddisorders@uth.tmc.edu
Contact: Giovana Zunta Soares, MD +1 (713)-486-2629 giovana.b.zuntasoares@uth.tmc.edu

Locations
United States, Texas
UT Center of Excellence on Mood Disorders Recruiting
Houston, Texas, United States, 77054
Contact: Danielle E Spiker, BA    713-486-2627    danielle.e.spiker@uth.tmc.edu   
Contact: Lindsay D Harris, BS    +1 (713) 486-2527    lindsay.d.harris@uth.tmc.edu   
Principal Investigator: Jair C Soares, MD         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Stanley Medical Research Institute
Investigators
Principal Investigator: Jair C Soares, MD The University of Texas Health Science Center, Houston
  More Information

Additional Information:
No publications provided

Responsible Party: Jair Soares, Professor & Chairman - PSY-Behavioral Sciences, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01797575     History of Changes
Other Study ID Numbers: HSC-MS-12-0046, SMRI, SMRI#11T-009
Study First Received: June 8, 2012
Last Updated: December 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center, Houston:
Bipolar Disorder
Mood Disorder
Bipolar Depression
Mood Swings

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Acetylcysteine
N-monoacetylcystine
Aspirin
Contraceptives, Oral
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 22, 2014