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

NCT00996242 | Completed

• 2 other identifiers: LYSINE107TGS-1049
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; L-lysine; PANSS

Outcome Measures

Primary Outcomes (1)

• Psychotic symptoms severity

  Eight weeks

Secondary Outcomes (1)

• Treatment safety assessment

  Eight weeks

Study Arms (1)

L-lysine

EXPERIMENTAL

Drug: L-lysine

Interventions

L-lysine DRUG

6 g/day for four weeks

L-lysine

Eligibility Criteria

• Age: 23 Years - 56 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• substance abuse, apart from smoking

Sponsors & Collaborators

• Göteborg University: lead
• Stanley Medical Research Institute: collaborator

Study Sites (1)

Sahlgrenska Univeristy Hospital

Gothenburg, SE 405 30, Sweden

Location

Related Publications (1)

• Wass C, Klamer D, Katsarogiannis E, Palsson E, Svensson L, Fejgin K, Bogren IB, Engel JA, Rembeck B. L-lysine as adjunctive treatment in patients with schizophrenia: a single-blinded, randomized, cross-over pilot study. BMC Med. 2011 Apr 18;9:40. doi: 10.1186/1741-7015-9-40.

  PMID: 21501494 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Lysine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 15, 2009
• First Posted: October 16, 2009
• Study Start: September 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: March 1, 2009
• Last Updated: October 16, 2009

Record last verified: 2009-10

Locations

SE (1)