Safety and Efficacy of Pyridoxal 5' -Phosphate in the Treatment of Tardive Dyskinesia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Medicure.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Medicure
ClinicalTrials.gov Identifier:
NCT00917293
First received: June 8, 2009
Last updated: January 30, 2012
Last verified: September 2011
  Purpose

The primary objective is to assess the safety and effectiveness of Pyridoxal 5'-Phosphate on the reduction of expressed symptoms of tardive dyskinesia in patients with schizophrenia and schizoaffective disorders.


Condition Intervention Phase
Tardive Dyskinesia
Drug: Pyridoxal 5'-Phosphate
Drug: Placebo
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 Randomized, Double-Blind, Placebo-Controlled, Comparative Study to Evaluate the Safety and Efficacy of Pyridoxal 5' -Phosphate in the Treatment of Tardive Dyskinesia in Patients With Schizophrenia and Schizoaffective Disorders

Resource links provided by NLM:


Further study details as provided by Medicure:

Primary Outcome Measures:
  • The primary outcome measure will be a reduction in the total AIMS score for items 1 through 7 (facial and oral movements, extremity movements and trunk movements) across treatment groups. . [ Time Frame: From baseline through to week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • An AIMS score reduction (items 1-7) across arms over course of study amongst completers; determine whether the proportion of responders differs between treatment arms; a reduction in the AIMS score, items 1 - 7 total, across treatment arms. [ Time Frame: From baseline through to Week 12 and Baseline compared to Week 12 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 140
Study Start Date: May 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pyridoxal 5'-Phosphate
Pyridoxal 5'-Phosphate, enteric-coated 2x 250mgs po bid.
Drug: Pyridoxal 5'-Phosphate
Pyridoxal 5'-Phosphate 500mgs po bid for 12 weeks.
Placebo Comparator: Placebo
Placebo 2 pills, po bid.
Drug: Placebo
Placebo 2 pills, po bid for 12 weeks.

Detailed Description:

This study will assess the effect of Pyridoxal 5'-Phosphate on the reduction of expressed symptoms of moderate to severe tardive dyskinesia in patients with schizophrenia and schizoaffective disorders who are on a stable dose, and regime, of either a long acting (i.e. depot/IM) or oral antipsychotic medication, as compared to placebo.

Symptoms will be assessed through the administration and scoring of Abnormal Involuntary Movement Scale (AIMS), specifically on items 1 through 7 (facial and oral movements, extremity movements and trunk movements) at each visit.

  Eligibility

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

Inclusion Criteria:

  1. Patients must have signed an informed consent document indicating that they understand the purpose of the study, its objectives, and the expectations of participation in the study and that they agree to participate in the study.
  2. Meet current diagnostic criteria for Schizophrenia (Disorganized [295. 10], Paranoid [295.30], or Residual [295.60]), or Schizoaffective Disorder [295.70] as defined by the DSM-IV for at least 3 months before screening.
  3. Have been on a stable dose and regime of a LAI for at least 3 injection intervals or oral antipsychotic for at least 1 month prior to randomization and are expected to remain on this stable dose and regime throughout their participation in the study.
  4. Meet current diagnostic criteria for Neuroleptic Induced Tardive Dyskinesia [333.82] as defined by the DSM-IV.
  5. Scoring ≥3 (moderate) on item 8, the "severity of abnormal movements overall" section of the AIMS.
  6. Score ≥3 (moderate) on at least one item, or ≥2 (mild) on at least 2 items, and an overall total score of ≥5 on items 1 through 7 (facial and oral movements, extremity movements and trunk movements) sections of the AIMS.
  7. Female patients must be post-menopausal for at least 2 years or surgically sterile. Women of childbearing potential must be using or agree to use a reliable form of contraception before entry into and during participation in the study. Reliable contraception can include an oral or other hormonal contraceptive started at least 4 weeks prior to randomization, a barrier method such as condoms or a diaphragm used with spermicide, or an intrauterine device (IUD).
  8. Patients must be capable of administering study medication themselves or will have assistance with the administration of the study medication consistently available throughout the study.

Exclusion Criteria:

  1. Involuntarily committed to a psychiatric hospital or correctional facility.
  2. A primary active DSM-IV diagnosis or co-morbid Axis 1 diagnosis other than schizophrenia or schizoaffective disorder.
  3. PANSS Score > than 120 at the screening visit.
  4. Current medical diagnosis that which could confound the interpretation or evaluation of the indication under study (i.e. Parkinson's Disease, Huntington's Chorea, Muscular Dystrophy, Tourette's Syndrome).
  5. History of liver cirrhosis, chronic active hepatitis (known positive serum test within 6 months of enrollment) or severe liver dysfunction, or liver transaminase ≥3 times ULN at screening (or obtained within 30 days prior to screening visit)
  6. History of malignancy during the last 5 years.
  7. Pregnant or any woman of childbearing potential who is not using a reliable form of contraception (this can include an oral or other hormonal contraceptive started at least 4 weeks prior to randomization, a barrier method such as condoms or a diaphragm used with spermicide, or an intrauterine device (IUD)). Women who have been post-menopausal for at least two years or who have undergone surgical sterilization are considered to be not of childbearing potential.
  8. Any medical, such as unstable cardiovascular, respiratory, neurological, renal, hepatic, immunological or endocrine, or psychiatric condition which in the opinion of the investigator makes the patient an unsuitable candidate for the study.
  9. History of any pre-existing gastrointestinal narrowing or inability to swallow the oral study medication whole with the aid of water.
  10. Male and female patients with a BMI of ≥20.
  11. Significant, ongoing alcohol or drug dependency within 3 months before screening as defined by the DSM-IV (nicotine will not be exclusionary).
  12. Significant risk of suicide or violent behavior as clinically assessed by the investigator.
  13. Participation in any other investigational drug or device study within 30 days of randomization.
  14. Patients who have previously participated in this study.
  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: NCT00917293

Contacts
Contact: George R. Thomas, PhD 204-928-7904 gthomas@canambioresearch.com
Contact: Michael C. Janzen, PhD 204-928-7908 mjanzen@canambioresearch.com

Locations
Canada, British Columbia
Vancouver Island Health Authority Recruiting
Victoria, British Columbia, Canada, V8R 4Z3
Principal Investigator: Richard Williams, MBBS, FRCPC         
Canada, Ontario
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M5T 1R8
Contact: Steve Mann    1-416-535-8501 ext 4104      
Contact: Carol Borlido    1-416-525-8501 ext 4321      
Principal Investigator: Gary J. Remington, MD, PhD         
Windsor Regional Hospital Recruiting
Windsor, Ontario, Canada, N9C 3Z4
Principal Investigator: Leonardo Cortese, MD         
India
Schizophrenia Research Foundation (SCARF) Mental Health Centre Recruiting
Chennai, TamilNadu, India, 600101
Contact: Sujit John, MA    91 44 26153971 ext 1073    sujitjohn@scarfindia.org   
Principal Investigator: Rangaswamy Thara, MD, PhD         
Sponsors and Collaborators
Medicure
Investigators
Principal Investigator: Gary J. Remington, MD, PhD Centre for Addiction and Mental Health
  More Information

No publications provided

Responsible Party: Medicure
ClinicalTrials.gov Identifier: NCT00917293     History of Changes
Other Study ID Numbers: 08030
Study First Received: June 8, 2009
Last Updated: January 30, 2012
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by Medicure:
Tardive Dyskinesia
Schizophrenia
Pyridoxal 5'-phosphate

Additional relevant MeSH terms:
Dyskinesias
Psychotic Disorders
Schizophrenia
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Pyridoxal
Pyridoxine
Pyridoxal Phosphate
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 10, 2014