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Completed

NCT Number: NCT00996242

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

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.

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Key information

Age range

23 year–56 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska Univeristy Hospital

Gothenburg, SE 405 30, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L-lysine

Drug

6 g/day for four weeks

Primary outcomes

  1. Psychotic symptoms severity

    Time frame: Eight weeks

Secondary outcomes

  1. Treatment safety assessment

    Time frame: Eight weeks

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Stanley Medical Research Institute

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Oct 16, 2009
Registry last updated
Oct 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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