SchizophreniaPhase 3NCT00179465
Treating Schizophrenia by Correcting Abnormal Brain Development
A Phase 3 study testing Tiagabine in people with Schizophrenia, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether treatment with tiagabine (Gabitril) during the early course of schizophrenia can fundamentally correct the brain deficits associated with the disease. This study is funded by the National Institutes of Health. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Tiagabine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Sep 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meets criteria for the diagnosis of schizophrenia, with onset of psychotic symptoms within the past 3 years.
- Currently on second-generation antipsychotics for at least 3 months.
- Age 18-25, otherwise healthy.
Who cannot join
- Diagnosis of schizoaffective disorder.
- Has failed two or more clinically adequate antipsychotic trials.
- History of seizures or any neurologic disorders.
- Pregnant or nursing women.
- Known HIV infection.
- Actively suicidal.
Show all 9Show fewer
- History of any substance dependence.
- Currently meets criteria for substance abuse/dependence.
- Other MRI exclusion criteria per Radiology Department protocols.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
About this study
Official title: Addition of Tiagabine to Second-Generation Antipsychotics in the Treatment of Recent-Onset Schizophrenia by Modification of Developmental Reorganization of the Prefrontal Cortex
The purpose of this study is to determine whether treatment with tiagabine (Gabitril) during the early course of schizophrenia can fundamentally correct the brain deficits associated with the disease.
This study is funded by the National Institutes of Health.
Read the detailed description
It is hypothesized that enhancement of GABA neurotransmission during the early course of the illness by tiagabine (Gabitril), a GABA transporter GAT-1-specific inhibitor and a FDA-approved anticonvulsant, will improve both clinical symptoms and working memory in schizophrenia. This improvement is postulated to be the result of tiagabine-mediated modification of the developmental synaptic pruning of prefrontal cortical circuitry. The occurrence of circuitry modification after tiagabine treatment will be assessed by the following independent methodologic approaches: MRI morphometric analysis of prefrontal gray matter volume and fMRI measurements of brain activity patterns during performance of tasks that probe working memory.
- Conditions
- Schizophrenia
- Being tested
- Tiagabine, Placebo
- Keywords
- Treatment, fMRI, Cognition, Brain development
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TiagabineDrug
Also called Antipsychotic
Up to 36 mg daily
PlaceboDrug
Also called Antipsychotic
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Antipsychotic plus study drug | Active comparator | Half of the subjects will receive the study medications in addition to their ongoing antipsychotic regimen. Receives: Drug: Tiagabine |
| Antipsychotics plus placebo | Placebo comparator | Half of the subjects will receive placebo in addition to their antipsychotic regimen. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive Functions-Working Memory
Working memory will be assessed using the n-back working memory test
Measured: Working memory will be assessed at baseline and at 6-month time point to see if working memory changes after 6 months compared to baseline measurement
Neurocognitive Functions-Executive Function
Executive function, which is a complex form of working memory, will be assessed using the MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia) battery
Measured: Executive function will be assessed at baseline and at 6-month time point to see if executive function changes after 6 months compared to baseline measure
Secondary outcomes (1)
Clinical symptoms
Positive and negative symptoms will be quantified using PANSS (positive and negative symptom scale)
Measured: Symptoms will be assessed at baseline and at 6-month time point to see if symptoms change after 6 months compared to baseline measures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startNov 2003
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth-Hitchcock Medical Center
- Responsible party
- Principal investigator, Tsung-Ung Wilson Woo, Beth Israel Deaconess Medical Center
- Investigators
- T.-U. Wilson Woo, M.D., Ph.D., Principal investigator, Beth Israel Deaconess Medical Center, Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00179465
- Sponsor's protocol ID
- 2004P000078
- Status last verified
- Jan 2025
- First submitted
- 12 Sep 2005
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Woo TU, Crowell AL. Targeting synapses and myelin in the prevention of schizophrenia. Schizophr Res. 2005 Mar 1;73(2-3):193-207. doi: 10.1016/j.schres.2004.07.022.
PubMed 15653262Woo TU, Whitehead RE, Melchitzky DS, Lewis DA. A subclass of prefrontal gamma-aminobutyric acid axon terminals are selectively altered in schizophrenia. Proc Natl Acad Sci U S A. 1998 Apr 28;95(9):5341-6. doi: 10.1073/pnas.95.9.5341.
PubMed 9560277Woo TU, Spencer K, McCarley RW. Gamma oscillation deficits and the onset and early progression of schizophrenia. Harv Rev Psychiatry. 2010 May-Jun;18(3):173-89. doi: 10.3109/10673221003747609.
PubMed 20415633
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of Tiagabine to Second-Generation Antipsychotics in the Treatment of Recent-Onset Schizophrenia by Modification of Developmental Reorganization of the Prefrontal Cortex
- ClinicalTrials.gov ID
- NCT00179465
- Acronym / sponsor ID
- 2004P000078
- Conditions
- Schizophrenia
- Keywords
- Treatment, fMRI, Cognition, Brain development
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Dartmouth-Hitchcock Medical Center
- Study start
- Nov 2003 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 16 Sep 2005 (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 purpose of this study is to determine whether treatment with tiagabine (Gabitril) during the early course of schizophrenia can fundamentally correct the brain deficits associated with the disease.
This study is funded by the National Institutes of Health.
Detailed description
It is hypothesized that enhancement of GABA neurotransmission during the early course of the illness by tiagabine (Gabitril), a GABA transporter GAT-1-specific inhibitor and a FDA-approved anticonvulsant, will improve both clinical symptoms and working memory in schizophrenia. This improvement is postulated to be the result of tiagabine-mediated modification of the developmental synaptic pruning of prefrontal cortical circuitry. The occurrence of circuitry modification after tiagabine treatment will be assessed by the following independent methodologic approaches: MRI morphometric analysis of prefrontal gray matter volume and fMRI measurements of brain activity patterns during performance of tasks that probe working memory.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antipsychotic plus study drug | Active comparator | Drug: TiagabineHalf of the subjects will receive the study medications in addition to their ongoing antipsychotic regimen. |
| Antipsychotics plus placebo | Placebo comparator | Drug: PlaceboHalf of the subjects will receive placebo in addition to their antipsychotic regimen. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Meets criteria for the diagnosis of schizophrenia, with onset of psychotic symptoms within the past 3 years.
- Currently on second-generation antipsychotics for at least 3 months.
- Age 18-25, otherwise healthy.
Key exclusion criteria (9 listed)
- Diagnosis of schizoaffective disorder.
- Has failed two or more clinically adequate antipsychotic trials.
- History of seizures or any neurologic disorders.
- Pregnant or nursing women.
- Known HIV infection.
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 |
|---|---|---|
| TiagabineAlso: AntipsychoticUp to 36 mg daily | Drug | Antipsychotic plus study drug |
| PlaceboAlso: AntipsychoticPlacebo | Drug | Antipsychotics plus placebo |
Primary outcome
Neurocognitive Functions-Working Memory
Time frame: Working memory will be assessed at baseline and at 6-month time point to see if working memory changes after 6 months compared to baseline measurement
Working memory will be assessed using the n-back working memory test
Neurocognitive Functions-Executive Function
Time frame: Executive function will be assessed at baseline and at 6-month time point to see if executive function changes after 6 months compared to baseline measure
Executive function, which is a complex form of working memory, will be assessed using the MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia) battery
1 secondary outcome
Clinical symptoms
Time frame: Symptoms will be assessed at baseline and at 6-month time point to see if symptoms change after 6 months compared to baseline measures
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Background: PubMed 15653262Woo TU, Crowell AL. Targeting synapses and myelin in the prevention of schizophrenia. Schizophr Res. 2005 Mar 1;73(2-3):193-207. doi: 10.1016/j.schres.2004.07.022.
- Background: PubMed 9560277Woo TU, Whitehead RE, Melchitzky DS, Lewis DA. A subclass of prefrontal gamma-aminobutyric acid axon terminals are selectively altered in schizophrenia. Proc Natl Acad Sci U S A. 1998 Apr 28;95(9):5341-6. doi: 10.1073/pnas.95.9.5341.
- Background: PubMed 20415633Woo TU, Spencer K, McCarley RW. Gamma oscillation deficits and the onset and early progression of schizophrenia. Harv Rev Psychiatry. 2010 May-Jun;18(3):173-89. doi: 10.3109/10673221003747609.
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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.
T.-U. Wilson Woo, M.D., Ph.D. principal investigator
Beth Israel Deaconess Medical Center, Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tiagabine in people with Schizophrenia, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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 3 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 27 Jan 2025. 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 United States. 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Neurocognitive Functions-Working Memory (time frame: Working memory will be assessed at baseline and at 6-month time point to see if working memory changes after 6 months compared to baseline measurement). The study lists 2 primary outcomes in all. 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 NCT00179465, which also lists 3 linked publications.
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 27 Jan 2025.