SchizophreniaPhase 3NCT00300404
Effect of Specific Anti-Toxoplasmatic Add-on Medication in Toxoplasma Gondii Seropositive Individuals With Schizophrenia or Major Depression
A Phase 3 study testing daraprim, pyrimethamine and folinic acid in people with Schizophrenia and Major Depression, run by Zentrum für Integrative Psychiatrie.
Trial summary
We investigate whether the add-on specific antitoxoplasmatic medication has positive effects in individuals with schizophrenia or major depression seropositive for Toxoplasma gondii (TG) infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Major Depression
- What is being tested?
- daraprim, pyrimethamine and folinic acid
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2002to Sep 2005
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Schizophrenia or Major Depression
- Both genders
- Adult
- Patients are able to give informed consent
Who cannot join
- Additional diagnosis of substance abuse/dependency
- Continuous treatment with medication not compatible with study medication
- Medical status not compatible with study medication
- Any condition that increases study risk considerably
- Pregnancy, nursing
About this study
Official title: Effect of Add-on Anti-Toxoplasmosis Treatment on Parameters Defining Toxoplasma Gondii Infection and on Psychopathology in Patients With Schizophrenia or Major Depression Serologically Positive for Toxoplasma Gondii - Phase 3 Study
We investigate whether the add-on specific antitoxoplasmatic medication has positive effects in individuals with schizophrenia or major depression seropositive for Toxoplasma gondii (TG) infection. As TG modulates neurotransmitter metabolism affecting serotonin and dopamine we hypothesize that this chronic persistent infection might play a role for depressive and psychotic symptomatology. Therefore, on the basis of an ex juvantibus approach, specific anti TG medication might further improve psychiatric symptomatology in affected patients. This is investigated in a double-blind, placebo-controlled, randomized treatment trial.
- Conditions
- Schizophrenia, Major Depression
- Being tested
- daraprim, pyrimethamine, folinic acid
- Keywords
- Schizophrenia, Psychosis, Depression, Affective Disorder
- Medical subject headings
- Schizophrenia, Depressive Disorder, Major, Psychotic Disorders, Depression, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
daraprimDrug
pyrimethamineDrug
folinic acidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychopathology ratings
Secondary outcomes (1)
TG infection parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2006 (estimated)
- Study startJan 2002
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Zentrum für Integrative Psychiatrie
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Investigators
- Dunja Hinze-Selch, MD, Principal investigator, Zentrum für Integrative Psychiatrie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300404
- Sponsor's protocol ID
- TOXO-KI-TT
- Other IDs
- SMRI grant # 01T-404
- Status last verified
- Mar 2006
- First submitted
- 7 Mar 2006
- Last updated
- 22 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Add-on Anti-Toxoplasmosis Treatment on Parameters Defining Toxoplasma Gondii Infection and on Psychopathology in Patients With Schizophrenia or Major Depression Serologically Positive for Toxoplasma Gondii - Phase 3 Study
- ClinicalTrials.gov ID
- NCT00300404
- Acronym / sponsor ID
- TOXO-KI-TT
- Conditions
- Schizophrenia, Major Depression
- Keywords
- Schizophrenia, Psychosis, Depression, Affective Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Zentrum für Integrative PsychiatrieUniversity, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Study start
- Jan 2002
- Study completion
- Sep 2005
- First posted
- 8 Mar 2006 (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.
We investigate whether the add-on specific antitoxoplasmatic medication has positive effects in individuals with schizophrenia or major depression seropositive for Toxoplasma gondii (TG) infection. As TG modulates neurotransmitter metabolism affecting serotonin and dopamine we hypothesize that this chronic persistent infection might play a role for depressive and psychotic symptomatology. Therefore, on the basis of an ex juvantibus approach, specific anti TG medication might further improve psychiatric symptomatology in affected patients. This is investigated in a double-blind, placebo-controlled, randomized treatment trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Schizophrenia or Major Depression
- Both genders
- Adult
- Patients are able to give informed consent
Key exclusion criteria (5 listed)
- Additional diagnosis of substance abuse/dependency
- Continuous treatment with medication not compatible with study medication
- Medical status not compatible with study medication
- Any condition that increases study risk considerably
- Pregnancy, nursing
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 |
|---|---|---|
| daraprim | Drug | – |
| pyrimethamine | Drug | – |
| folinic acid | Drug | – |
Primary outcome
Psychopathology ratings
1 secondary outcome
TG infection parameters
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 22 May 2006.
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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.
Dunja Hinze-Selch, MD principal investigator
Zentrum für Integrative Psychiatrie
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing daraprim, pyrimethamine and folinic acid in people with Schizophrenia and Major Depression, run by Zentrum für Integrative Psychiatrie.
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 5 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 22 May 2006. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Psychopathology ratings. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2006.