SchizophreniaNCT00996242
An Exploratory Open Label Study of Adjunctive L-lysine Treatment in Patients With Schizophrenia
A study testing L-lysine in people with Schizophrenia, run by Göteborg University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 56 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- L-lysine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2007to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 56 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- substance abuse, apart from smoking
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- L-lysine
- Keywords
- Schizophrenia, L-lysine, PANSS
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-lysineDrug
6 g/day for four weeks
| Study group | Role | What they receive |
|---|---|---|
| L-lysine | Experimental | Not described Receives: Drug: L-lysine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychotic symptoms severity
Measured: Eight weeks
Secondary outcomes (1)
Treatment safety assessment
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startSep 2007
- Primary completionSep 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996242
- Sponsor's protocol ID
- LYSINE1
- Other IDs
- 07TGS-1049
- Status last verified
- Oct 2009
- First submitted
- 15 Oct 2009
- Last updated
- 16 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21501494
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Open Label Study of Adjunctive L-lysine Treatment in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00996242
- Acronym / sponsor ID
- LYSINE1
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, L-lysine, PANSS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Study start
- Sep 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 16 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| L-lysine | Experimental | Drug: L-lysine |
Who may qualify
- Ages
- 23 to 56 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- substance abuse, apart from smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-lysine6 g/day for four weeks | Drug | L-lysine |
Primary outcome
Psychotic symptoms severity
Time frame: Eight weeks
1 secondary outcome
Treatment safety assessment
Time frame: Eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2009.
- Derived from this study: PubMed 21501494Wass 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-lysine in people with Schizophrenia, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychotic symptoms severity (time frame: Eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00996242, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2009.