An Exploratory Open Label Study of Adjunctive L-lysine Treatment in Patients With Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by:
Göteborg University
ClinicalTrials.gov Identifier:
NCT00996242
First received: October 15, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

The objective of the present study was to investigate the possibility of using L-lysine, an amino acid that occurs naturally in food and which interferes with nitric oxide (NO) production, for the treatment of schizophrenia. L-lysine, 6 g/day, was administered to ten patients with schizophrenia as an add-on treatment to conventional antipsychotic treatment. The study was designed as a single-blinded, cross-over study where patients were randomly assigned to initial treatment with either L-lysine or placebo and screened at baseline, after four weeks when treatment was crossed over, and after eight weeks when treatment was terminated. The four-week L-lysine treatment regimen caused a significant increased in blood concentration of the amino acid and was tolerated well. The analysis of outcome measures showed a significant decrease in symptom severity as measured by the Positive and Negative Syndrome Scale (PANSS). Furthermore, the patient's ability to solve the Wisconsin Card Sorting Task (WCST) was significantly improved indicating increased problem solving capacity and cognitive flexibility. Subjective reports from three of the patients also indicated decreased symptom severity and enhanced cognitive functioning. In summary, these findings suggest potential beneficial effects of L-lysine treatment on symptom severity and cognitive deficits in patients with schizophrenia.


Condition Intervention
Schizophrenia
Drug: L-lysine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: An Exploratory Open Label Study of Adjunctive L-lysine Treatment in Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • Psychotic symptoms severity [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment safety assessment [ Time Frame: Eight weeks ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: September 2007
Study Completion Date: March 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: L-lysine Drug: L-lysine
6 g/day for four weeks

  Eligibility

Ages Eligible for Study:   23 Years to 56 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a stable phase of illness
  • a stable dose of antipsychotic medication
  • no other major medical conditions or other psychiatric diagnosis
  • normal admission laboratory tests and vital signs

Exclusion Criteria:

  • substance abuse, apart from smoking
  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: NCT00996242

Locations
Sweden
Sahlgrenska Univeristy Hospital
Gothenburg, Sweden, SE 405 30
Sponsors and Collaborators
Göteborg University
Stanley Medical Research Institute
  More Information

No publications provided by Göteborg University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Birgitta Rembeck, PhD, The Sahlgrenska University Hospital, Gothenburg, Sweden
ClinicalTrials.gov Identifier: NCT00996242     History of Changes
Other Study ID Numbers: LYSINE1, 07TGS-1049
Study First Received: October 15, 2009
Last Updated: October 15, 2009
Health Authority: Sweden: Gothenburg Regional Review Board
Sweden: Medical Products Agency

Keywords provided by Göteborg University:
Schizophrenia
L-lysine
PANSS

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on August 25, 2014