| CTRI Number |
CTRI/2012/02/002411 [Registered on: 08/02/2012] Trial Registered Retrospectively |
| Last Modified On: |
05/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To check safety and efficacy of Pyridoxal 5 -Phosphate in the treatment of Movement disorder which is a side effect of antipsychotic medications intake. |
|
Scientific Title of Study
|
A 12-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP COMPARATIVE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PYRIDOXAL 5’ -PHOSPHATE MONOHYDRATE IN THE TREATMENT OF TARDIVE DYSKINESIA IN PATIENTS WITH SCHIZOPHRENIA AND SCHIZOAFFECTIVE DISORDERS. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT00917293 |
ClinicalTrials.gov |
| Protocol # 08030, Amendment 3.1 Dated January 8th, 2010 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Thara Rangaswamy |
| Designation |
Director of SCARF (Schizophrenia Research Foundation)Mental Health Centre |
| Affiliation |
Schizophrenia Research Foundation |
| Address |
Schizophrenia Research Foundation (SCARF), R/7A, north main Road, Anna Nagar (West Extension), Chennai, Tamil Nadu, India
Schizophrenia Research Foundation (SCARF), R/7A, north main Road, Anna Nagar (West Extension), Chennai, Tamil Nadu, India
Chennai
TAMIL NADU
600101
India |
| Phone |
914426153971 |
| Fax |
914443538110 |
| Email |
thara@scarfindia.org |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Shoibal Mukherjee |
| Designation |
Vice President, Medical |
| Affiliation |
IQVIA RDS (India) Private Limited |
| Address |
8th Floor, DLF Square
M Block, Jacaranda Marg
DLF City Phase II
Gurgaon, Haryana
India - 122002
Gurgaon
HARYANA
122002
India |
| Phone |
91-7838652395 |
| Fax |
|
| Email |
shoibal.mukherjee@quintiles.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Suchela Srivatsa |
| Designation |
Director – Clinical Operations |
| Affiliation |
IQVIA RDS (India) Private Limited |
| Address |
301-A-1, Leela Business Park
MV Road, Andheri East, Mumbai 400059
Mumbai
MAHARASHTRA
400059
India |
| Phone |
91-9820712114 |
| Fax |
91-22-56774343 |
| Email |
suchela.srivatsa@quintiles.com |
|
|
Source of Monetary or Material Support
|
| Medicure International Inc.,
c/o Medicure Inc.
2-1250 Waverley Street,
Winnipeg, MB R3T 6C6,
Tel: 1-204-487-7412,1-204-928--7904
Fax: 1-204-488-9823
|
|
|
Primary Sponsor
|
| Name |
Medicure International Inc |
| Address |
2-1250 Waverley Street,
Winnipeg, MB R3T 6C6,
Tel: 1-204-487-7412,1-204-928--7904
Fax: 1-204-488-9823
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Quintiles Research India Private Limited |
B-101-106, Shapath IV, Sarkhej-Gandhinagar Road, Ahmedabad - 380051, Gujarat |
|
|
Countries of Recruitment
|
Canada
India
United States of America |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Thara Rangaswamy |
Schizophrenia Research Foundation (SCARF) |
R/7A, north main Road, Anna Nagar (West Extension), Chennai- 600101, Tamil Nadu, India
Chennai
TAMIL NADU |
91-4426153971
91-4443538110
thara@scarfindia.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SCARF, Chennai, (Principal Investigator-Dr. Thara Rangaswamy) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F208||Other schizophrenia, Treatment of tardive dyskinesia in patients with schizophrenia and schizoaffective disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Placebo 2 pills, po bid for 12 weeks |
| Intervention |
Pyridoxal 5-Phosphate |
Pyridoxal 5-Phosphate 500mgs po bid for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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. Parkinsons Disease, Huntingtons Chorea, Muscular Dystrophy, Tourettes 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. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 from baseline through to week 12. |
From baseline through to week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| •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. |
From baseline through to Week 12 and Baseline compared to Week 12 |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
24/02/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
02/06/2009 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a 12 week, randomized, double-blind, placebocontrolled, parallel group comparative study. Patients will be screened and if eligible will be randomized (Day 1) to receive either P5’-P at 1000 mg/day (2x 250 mg po b.i.d) or placebo (2x pills po b.i.d), beginning at Day 1 and continuing daily for 12 consecutive weeks (Day 85). Assessments for tardive dyskinesia will occur at screening [Day 1] (to determine eligibility) and week 2 [Day 15], week 4 [Day 29], week 8 [Day 57] and week 12 [Day 85]. |