Pyridoxal Kinase Activity in Tardive Dyskinesia

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Brief Title

Pyridoxal Kinase Activity in Tardive Dyskinesia

Official Title

Pyridoxal Kinase Activity in Schizophrenia Patients Without Versus With Tardive Dyskinesia Treated With Vitamin B6

Brief Summary

      Objectives: The mechanisms of tardive dyskinesia (TD) remain unclear, although
      pathophysiologic theories have proposed mechanisms such as dopamine receptor
      supersensitivity, the degeneration of cholinergic striatal interneurons, γ-aminobutyric acid
      (GABA) depletion, and an excess of free radicals.

      Prior development of second generation antipsychotic agents, tardive movement disorders were
      widespread among neuroleptics treated patients. There were great expectations of the new
      novel drugs. Unfortunately, reports about tardive movement disturbances induced by these
      medications became more and more frequent, although it has been in use for less than two
      decades.

      A recent study demonstrated that schizophrenic and schizoaffective patients suffering from TD
      had the mean level of pyridoxal 5'-phosphate (PLP) below lower limit of normal range, while
      those patients without TD had normal values. At the same time, some open and double-blind
      placebo-controlled, randomized clinical studies showed that vitamin B6 was very effective in
      treatment of TD.

      Pyridoxal kinase is a key enzyme for the biosynthesis of PLP, the biologically active form of
      vitamin B6. Some publications reported that the finding of high vitamin B6 levels is
      consistent with recent reports of low levels of PLP and low activity of pyridoxal kinase. It
      may explain the functional need for high-dose vitamin B6 supplementation in subjects with TD.

      Methods: A multicenter study including 300 schizophrenia and schizoaffective subjects will be
      performed. The trial will be consisted of 2 parts: the first part a single comparison
      pyridoxal kinase plasma activity in patients with and without TD; in the second part only TD
      schizophrenia and schizoaffective patients will continue. It will be a 12-week, randomized,
      double-blind placebo-controlled trial. Vitamin B6 (1200 mg/day) or placebo capsules will be
      added to the stable ongoing antipsychotic treatment of 150 schizophrenia patients.
      Participants will be assessed at baseline and after every 2 weeks of treatment till week 12.
      Pyridoxal kinase activity will be compared between patients who positively respond to vitamin
      B6 versus non responders. In addition, PLP levels will be monitored at baseline and at the
      end of the study.

      A battery of research tools will be used for assessment of movement disorders,
      psychopathology, and side effects. The study will be performed along a period of 2 years.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Extrapyramidal Symptom Rating Scale (ESRS)

Secondary Outcome

 The Positive and Negative Syndrome Scale (PANSS)

Condition

Tardive Dyskinesia

Intervention

Pyridoxine

Study Arms / Comparison Groups

 vitamin B6 (pyridoxine)
Description:  The 150 participating subjects will be randomized into 2 groups: 75 patients will receive vitamin B6 (1200 mg/day) and 75 patients will receive placebo, each for 12 weeks in a double-blind mode

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

0

Start Date

July 2011

Completion Date

July 2011

Primary Completion Date

July 2011

Eligibility Criteria

        Inclusion Criteria:

          -  Inpatients

          -  DSM-IV diagnosis of schizophrenia or schizoaffective disorder with and without tardive
             dyskinesia (TD)

          -  Total ESRS score should be more than 20 in subjects with TD

          -  Ability to provide a written informed consent

        Exclusion Criteria:

          -  Patients with concurrent medical illness or any movement disorder resemble TD

          -  Patients who received any vitamin medication

          -  Evidence of substance or alcohol abuse or a family history of movement disorder.

          -  Pregnancy and/or lactation.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT01908452

Organization ID

LMRK0911


Responsible Party

Principal Investigator

Study Sponsor

Beersheva Mental Health Center

Collaborators

 Sha'ar Menashe Mental Health Center

Study Sponsor

, , 


Verification Date

July 2011