D-serine Adjuvant Treatment for Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00215904
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : July 9, 2012
Information provided by (Responsible Party):
Heresco-Levi Uriel, Herzog Hospital

September 18, 2005
September 22, 2005
July 9, 2012
August 2003
May 2008   (Final data collection date for primary outcome measure)
  • UPDRS scores [ Time Frame: 6 weeks ]
  • PANSS scores [ Time Frame: 6 weeks ]
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Complete list of historical versions of study NCT00215904 on Archive Site
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D-serine Adjuvant Treatment for Parkinson's Disease
D-serine Adjuvant Treatment for Parkinson's Disease

The proposed experiment will evaluate the effects of the NMDA receptor full agonist D-serine (~2g/day) on persistent symptoms of Parkinson's Disease and on antiparkinsonian drugs-induced dyskinesias.

D-serine will be used as add-on therapy to on-going medications received by Parkinson's Disease patients. The rational for this study stems from observations made in pervious clinical trials with schizophrenia patients, in which it was demonstrated that D-serine adjuvant treatment resulted in:1)improvement of parkinsonian side effects induced by antipsychotic drugs and 2) improvement of depression and negative (i.e apathy, blunted effects, anhedonia) symptoms which are similar to symptoms encountered in Parkinson's Disease.

The study will have a crossover design in accordance to which each patient will receive, in random order D-serine and placebo for a 6 weeks period each. Thus, any participant will have the opportunity to receive the experimental treatment.

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Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Parkinson's Disease
Drug: D-serine (~2g/day)
Two 6 weeks treatment arms. One arm: adjuvant treatment with D-serine (~2g/day). Second arm : adjuvant treatment with placebo (~2g/day).
  • Placebo Comparator: 1
    Intervention: Drug: D-serine (~2g/day)
  • Experimental: 2
    Intervention: Drug: D-serine (~2g/day)
Gelfin E, Kaufman Y, Korn-Lubetzki I, Bloch B, Kremer I, Javitt DC, Heresco-Levy U. D-serine adjuvant treatment alleviates behavioural and motor symptoms in Parkinson's disease. Int J Neuropsychopharmacol. 2012 May;15(4):543-9. doi: 10.1017/S1461145711001015. Epub 2011 Jul 7.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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May 2008
May 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • PD diagnosis
  • ≥2 on UPDRS items 32,33
  • receive treatment with L-dopa alone or in combination with other antiparkinsonian medications.

Exclusion Criteria:

  • current or previous history of other neurological disorders
  • unstable medical conditions
  • renal pathology
  • pregnant female patients excluded
Sexes Eligible for Study: All
30 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Heresco-Levi Uriel, Herzog Hospital
Herzog Hospital
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Principal Investigator: Uriel Heresco-Levy Ezrath Nashim - Herzog Memorial Hospital
Herzog Hospital
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP