ToxoplasmosisPhase 4NCT02011750
Pilot Trial of Valproate as Adjunctive Treatment for Toxoplasma Gondii Infection in Early Course Schizophrenia
A Phase 4 study testing Sodium Valproate treatment in people with Toxoplasmosis and Schizophrenia, run by University of Pittsburgh at 1 site in Egypt.
Trial summary
This is an exploratory study in Egypt that will combine a treatment trial among early course schizophrenia (ECSZ) patients with key analyses suggested by rodent studies. Specifically, the study will test the provocative results from animal studies indicating an impact of Toxoplasma Gondii (TOX) exposure on novelty… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Toxoplasmosis, Schizophrenia
- What is being tested?
- Sodium Valproate treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2013to 31 Dec 2017
- Phase
- Phase 4
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Written informed consent
- Adult men or women (ages 18-50 years)
- Schizophrenia / schizoaffective disorder (DSM IV)
- Duration of illness < 5 years (since onset of psychosis)
- On a stable dose of an antipsychotic for at least a month
- Scores 4 or more on at least one item of the Positive and Negative Syndrome Scale.
Who cannot join
- Substance abuse in the past month/dependence past 6 months
- History of / or current medical/neurological illnesses e.g. mental retardation (DSM-IV) or epilepsy;
- Medical conditions that are judged by the consulting internist and research staff to be unstable
- Pregnant or breast-feeding women
- Known allergy or serious adverse event to DEP, Received Chlorpromazine, Trimethoprim or DEP for up to 6 months prior to study entry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Trial of Valproate as Adjunctive Treatment for Toxoplasma Gondii
This is an exploratory study in Egypt that will combine a treatment trial among early course schizophrenia (ECSZ) patients with key analyses suggested by rodent studies. Specifically, the study will test the provocative results from animal studies indicating an impact of Toxoplasma Gondii (TOX) exposure on novelty seeking. The study will also test whether exposure to TOX is associated with other cognitive and behavioral changes, as well as changes in overall social function. We will also explore the relative efficacy of Sodium Valproate (Depakote, DEP) in improving clinical and overall social function among TOX exposed and unexposed patients.
Hypotheses
- At baseline, TOX exposure is associated with increased novelty seeking, clinical severity, and impaired cognitive and overall social function in patients with SZ.
- Adjunctive DEP treatment improves clinical symptoms, cognitive and social function in SZ, particularly among TOX exposed SZ patients.
- Exploratory hypothesis: adjunctive DEP reduces serological indices of TOX infection (VIP and TH levels).
- Conditions
- Toxoplasmosis, Schizophrenia
- Being tested
- Sodium Valproate treatment, Placebo
- Keywords
- schizophrenia, toxoplasmosis
- Medical subject headings
- Toxoplasmosis, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Valproate treatmentDrug
Also called Depakote
Sodium Valproate treatment:During the entry period, all patients will have a placebo run-in for two weeks after which they will be evaluated for the outcome variables and then randomized to either Sodium Valproate (Depakote, DEP) or placebo (PLA) group in a 1:1 proportion. For the Sodium Valproate treatment group, this will be followed by a two week period to adjust the dose of DEP and attain therapeutic levels (50-100 µg/mL). Then DEP treatment will continue for 16 more weeks, after which DEP will be discontinued. Subject will be followed up for four weeks post-DEP discontinuation to monitor delayed adverse side effects.
PlaceboDrug
Placebo: During the entry period, all patients will have a placebo run-in for two weeks after which they will be evaluated for the outcome variables and then randomized to either the experimental Sodium Valproate (Depakote, or DEP) or placebo (PLA) group in a 1:1 proportion. For the PLA group, this will be followed by a two week period of placebo during which members of the experimental Sodium Valproate (Depakote/DEP) will have DEP dose adjusted to attain therapeutic levels (50-100 µg/mL). Then PLA treatment will continue for 16 more weeks. Subjects will be followed up for four weeks post PLA-discontinuation to monitor for delayed adverse side effects.
| Study group | Role | What they receive |
|---|---|---|
| Sodium Valproate treatment | Experimental | Sodium Valproate treatment:During the entry period, all patients will have a placebo run-in for two weeks after which they will be evaluated for the outcome variables and then randomized to either Sodium Valproate (Depakote, DEP) or placebo (PLA) group in a 1:1 proportion. For the Sodium Valproate treatment grou, this will be followed by a two week period to adjust the dose of DEP and attain therapeutic levels (50-100 µg/mL). Then DEP treatment will continue for 16 more weeks, after which DEP will be discontinued. Subject will be followed up for four weeks post-DEP discontinuation to monitor delayed adverse side effects. Receives: Drug: Sodium Valproate treatment; Drug: Placebo |
| Placebo | Placebo comparator | Placebo Comparator: During the entry period, all patients will have a placebo run-in for two weeks after which they will be evaluated for the outcome variables and then randomized to either the experimental Sodium Valproate (Depakote, or DEP) or placebo (PLA) group in a 1:1 proportion. For the PLA group, this will be followed by a two week period of placebo during which members of the experimental Sodium Valproate (Depakote/DEP) will have DEP dose adjusted to attain therapeutic levels (50-100 µg/mL). Then PLA treatment will continue for 16 more weeks. Subjects will be followed up for four weeks post PLA-discontinuation to monitor for delayed adverse side effects. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Severity
Clinical Severity will be measured by the Positive and Negative Syndrome Scale (PANSS),a 7 point rating scale for 30 psychopathological items based on interviews or reports.
Measured: Clinical severity will be assessed during week 20 of the study.
Cognitive Domains assessed via the Arabic version of the Penn CNB
Cognitive domains will be assessed using the Arabic version of the Penn Computerized Neuropsychological Battery (CNB), which includes cognitive measures that distinguish SZ cases and relatives from controls. Accuracy and response time are recorded.
Measured: Cognitive domains wil be measured in week 16 of the study
Social Function assessed via the Quality of Life Scale
Overall Social function will be measured by the Quality of Life Scale, which measures interpersonal, social and occupational functioning.
Measured: Social functioing will be assessed during week during week 16.
Cognitive domains assessed via Trails Making Test
Cognitive domains will be assessed using the Trails Making Test, a neuropsychological test of attention and task switching.
Measured: Cognitive domains will be assessed in week 16 of the study
Social Function -assessed via the GAF scale
Social functioning will be assessed using the Global Assessment of Functioning (GAF), a global measure of function and symptom severity.
Measured: Social functioning will be assessed during week 16
Social Functioning assessed via the Short Form
Social functioning will be assessed via the Short Form, a multi-item scale that consists of 8 scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
Measured: Social functioning will be assessed during week 16
Secondary outcomes (1)
Side effects
Participants will be monitored for adverse reactions to study medication through week 20.
Measured: Side effects will be measured during week 20 of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study start1 Apr 2013
- Primary completion30 Oct 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ToxoplasmosisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University, Stanley Medical Research Institute
- Responsible party
- Principal investigator, Hader Mansour, MD, University of Pittsburgh
- Investigators
- Hader Mansour, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011750
- Sponsor's protocol ID
- PRO12020320
- Status last verified
- Feb 2018
- First submitted
- 21 Jun 2013
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Valproate as Adjunctive Treatment for Toxoplasma Gondii
- ClinicalTrials.gov ID
- NCT02011750
- Acronym / sponsor ID
- PRO12020320
- Conditions
- Toxoplasmosis, Schizophrenia
- Keywords
- schizophrenia, toxoplasmosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Mansoura University, Stanley Medical Research Institute
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 13 Dec 2013 (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.
This is an exploratory study in Egypt that will combine a treatment trial among early course schizophrenia (ECSZ) patients with key analyses suggested by rodent studies. Specifically, the study will test the provocative results from animal studies indicating an impact of Toxoplasma Gondii (TOX) exposure on novelty seeking. The study will also test whether exposure to TOX is associated with other cognitive and behavioral changes, as well as changes in overall social function. We will also explore the relative efficacy of Sodium Valproate (Depakote, DEP) in improving clinical and overall social function among TOX exposed and unexposed patients.
Hypotheses
- At baseline, TOX exposure is associated with increased novelty seeking, clinical severity, and impaired cognitive and overall social function in patients with SZ.
- Adjunctive DEP treatment improves clinical symptoms, cognitive and social function in SZ, particularly among TOX exposed SZ patients.
- Exploratory hypothesis: adjunctive DEP reduces serological indices of TOX infection (VIP and TH levels).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Valproate treatment | Experimental | Drug: Sodium Valproate treatment, Drug: PlaceboSodium Valproate treatment:During the entry period, all patients will have a placebo run-in for two weeks after which they will be evaluated for the outcome variables and then randomized to either Sodium Valproate (Depakote, DEP) or placebo (PLA) group in a 1:1 proportion. For the Sodium Valproate treatment grou, this will be followed by a two week period to adjust the dose of DEP and attain therapeutic levels (50-100 µg/mL). Then DEP treatment will continue for 16 more weeks, after which DEP will be discontinued. Subject will be followed up for four weeks post-DEP discontinuation to monitor delayed adverse side effects. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Comparator: During the entry period, all patients will have a placebo run-in for two weeks after which they will be evaluated for the outcome variables and then randomized to either the experimental Sodium Valproate (Depakote, or DEP) or placebo (PLA) group in a 1:1 proportion. For the PLA group, this will be followed by a two week period of placebo during which members of the experimental Sodium Valproate (Depakote/DEP) will have DEP dose adjusted to attain therapeutic levels (50-100 µg/mL). Then PLA treatment will continue for 16 more weeks. Subjects will be followed up for four weeks post PLA-discontinuation to monitor for delayed adverse side effects. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Written informed consent
- Adult men or women (ages 18-50 years)
- Schizophrenia / schizoaffective disorder (DSM IV)
- Duration of illness < 5 years (since onset of psychosis)
- On a stable dose of an antipsychotic for at least a month
Key exclusion criteria (5 listed)
- Substance abuse in the past month/dependence past 6 months
- History of / or current medical/neurological illnesses e.g. mental retardation (DSM-IV) or epilepsy;
- Medical conditions that are judged by the consulting internist and research staff to be unstable
- Pregnant or breast-feeding women
- Known allergy or serious adverse event to DEP, Received Chlorpromazine, Trimethoprim or DEP for up to 6 months prior to study entry.
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 |
|---|---|---|
| Sodium Valproate treatmentAlso: DepakoteSodium Valproate treatment:During the entry period, all patients will have a placebo run-in for two weeks after which they will be evaluated for the outcome variables and then randomized to either Sodium Valproate (Depakote, DEP) or placebo (PLA) group in a 1:1 proportion. For the Sodium Valproate treatment group, this will be followed by a two week period to adjust the dose of DEP and attain therapeutic levels (50-100 µg/mL). Then DEP treatment will continue for 16 more weeks, after which DEP will be discontinued. Subject will be followed up for four weeks post-DEP discontinuation to monitor delayed adverse side effects. | Drug | Sodium Valproate treatment |
| PlaceboPlacebo: During the entry period, all patients will have a placebo run-in for two weeks after which they will be evaluated for the outcome variables and then randomized to either the experimental Sodium Valproate (Depakote, or DEP) or placebo (PLA) group in a 1:1 proportion. For the PLA group, this will be followed by a two week period of placebo during which members of the experimental Sodium Valproate (Depakote/DEP) will have DEP dose adjusted to attain therapeutic levels (50-100 µg/mL). Then PLA treatment will continue for 16 more weeks. Subjects will be followed up for four weeks post PLA-discontinuation to monitor for delayed adverse side effects. | Drug | Placebo, Sodium Valproate treatment |
Primary outcome
Clinical Severity
Time frame: Clinical severity will be assessed during week 20 of the study.
Clinical Severity will be measured by the Positive and Negative Syndrome Scale (PANSS),a 7 point rating scale for 30 psychopathological items based on interviews or reports.
Cognitive Domains assessed via the Arabic version of the Penn CNB
Time frame: Cognitive domains wil be measured in week 16 of the study
Cognitive domains will be assessed using the Arabic version of the Penn Computerized Neuropsychological Battery (CNB), which includes cognitive measures that distinguish SZ cases and relatives from controls. Accuracy and response time are recorded.
Social Function assessed via the Quality of Life Scale
Time frame: Social functioing will be assessed during week during week 16.
Overall Social function will be measured by the Quality of Life Scale, which measures interpersonal, social and occupational functioning.
Cognitive domains assessed via Trails Making Test
Time frame: Cognitive domains will be assessed in week 16 of the study
Cognitive domains will be assessed using the Trails Making Test, a neuropsychological test of attention and task switching.
Social Function -assessed via the GAF scale
Time frame: Social functioning will be assessed during week 16
Social functioning will be assessed using the Global Assessment of Functioning (GAF), a global measure of function and symptom severity.
Social Functioning assessed via the Short Form
Time frame: Social functioning will be assessed during week 16
Social functioning will be assessed via the Short Form, a multi-item scale that consists of 8 scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
1 secondary outcome
Side effects
Time frame: Side effects will be measured during week 20 of the study.
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 14 Feb 2018.
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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.
Hader Mansour, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium Valproate treatment in people with Toxoplasmosis and Schizophrenia, run by University of Pittsburgh at 1 site in Egypt.
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 6 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 14 Feb 2018. 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 Egypt. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Clinical Severity (time frame: Clinical severity will be assessed during week 20 of the study.). The study lists 6 primary outcomes in all. 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 14 Feb 2018.