SchizophreniaPhase 4NCT00194025
Valproate in Late Life Schizophrenia
A Phase 4 study testing Valproate in people with Schizophrenia, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The purpose of this research study is to analyze the effectiveness and tolerability of a medication, valproate ( Depakote and Depakote ER), in individuals age 50 years and older who have schizophrenia. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Valproate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Nov 2006
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have a diagnosis of schizophrenia as confirmed by the MINI
- Must be on antipsychotic medication
- Must be age 50 year or older
- Must be capable of providing written informed consent for study participation. In situations where individuals have guardians of person, guardian and subject must both provide written consent; and
- Must live in the Northeast Ohio area.
Who cannot join
- A primary psychiatric DSM Axis I diagnosis other than schizophrenia
- Actively abusing substances; or
- Medically unstable.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals of Cleveland
Cleveland, Ohio, 44106
About this study
Official title: Add-on Valproate in Late Life Schizophrenia
The purpose of this research study is to analyze the effectiveness and tolerability of a medication, valproate ( Depakote and Depakote ER), in individuals age 50 years and older who have schizophrenia.
Read the detailed description
It is known that up to 30% of individuals with schizophrenia continue to have symptoms even when treated with current FDA-approved medications intended to treat their schizophrenia. Anticonvulsant medications such as valproate (Depakote and Depakote ER) are known to be effective for related conditions such as bipolar disorder (manic depressive illness), and are also used by some physicians in clinical settings in combination with antipsychotic medications to treat symptoms of schizophrenia. Currently Depakote and Depakote ER are approved by the FDA to treat bipolar disorder and to treat seizure disorder. This study will test to see if Depakote and Depakote ER may improve symptoms of schizophrenia as well when added to antipsychotic medications.
- Conditions
- Schizophrenia
- Being tested
- Valproate
- Keywords
- Schizophrenia, Anticonvulsants, Valproic Acid, Valproate
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValproateDrug
Also called Depakote, Depakote ER
Enrolled individuals received adjunctive, open-label valproate semisodium, initially started as valproate semisodium delayed -release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended- release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50-100 µg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
| Study group | Role | What they receive |
|---|---|---|
| valproate | Experimental | All participants received open-label, add-on valproate. Receives: Drug: Valproate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Schizophrenia Psychopathology as Assessed by the Positive and Negative Symptom Scale (PANSS)
The best and worst possible overall PANSS scores are 30 and 210 units on a scale, respectively.
Measured: Baseline to 12 weeks
Secondary outcomes (9)
Change in Cognitive Status as Measured by the Mini-mental State Examination (MMSE)
The best and worst possible overall scores are 31 and 0 units on a scale, respectively.
Measured: Baseline to 12 weeks
Change in Overall Functioning as Measured by the Global Assessment Scale (GAS)
The best and worst possible GAS scores are 100 and 1 units on a scale, respectively.
Measured: Baseline to 12 weeks
Change in Depression Symptoms as Measured by the Geriatric Depression Scale (GDS)
The best and worst possible GDS scores are 0 and 30 units on a scale, respectively.
Measured: Baseline to 12 weeks
Change in Overall Mental Health Status as Measure by the Mental Composite Score (MCS) Subscale of the Short Form 36 Health Survey (SF-36)
The best and worst possible MCS scores are 100 and 1 units on a scale, respectively.
Measured: Baseline to 12 weeks
Change in Physical Health Status as Measure by the Physical Composite Score (PCS) Subscale of the Short Form 36 Health Survey (SF-36)
The best and worst possible PCS scores are 100 and 0 units on a scale, respectively.
Measured: Baseline to 12 weeks
Change in Extrapyramidal Symptoms as Assessed by the Abnormal Involuntary Movement Scale (AIMS)
The best and worst possible overall scores are 0 and 28 units on a scale, respectively.
Measured: Baseline to 12 weeks
Change in Extrapyramidal Symptoms as Assessed by the Simpson Angus Neurological Rating Scale (SAS)
The best and worst possible overall scores are 40 and 0 units on a scale, respectively.
Measured: Baseline to 12 weeks
Tolerability as Assessed by Weight Change
Measured: Baseline to 12 weeks
Tolerability as Measured by Mean Serum Level at Study Endpoint
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 University Hospitals Cleveland Medical CenterThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Investigators
- Martha Sajatovic, MD, Principal investigator, Case Western Reserve University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194025
- Sponsor's protocol ID
- 10850-01-L0348
- Status last verified
- Feb 2011
- First submitted
- 13 Sep 2005
- Last updated
- 6 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sajatovic M, Coconcea N, Ignacio RV, Blow FC, Hays RW, Cassidy KA, Meyer WJ. Adjunct extended-release valproate semisodium in late life schizophrenia. Int J Geriatr Psychiatry. 2008 Feb;23(2):142-7. doi: 10.1002/gps.1854.
PubMed 17582828
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Add-on Valproate in Late Life Schizophrenia
- ClinicalTrials.gov ID
- NCT00194025
- Acronym / sponsor ID
- 10850-01-L0348
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Anticonvulsants, Valproic Acid, Valproate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Nov 2004
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Posted 1 Mar 2011
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 research study is to analyze the effectiveness and tolerability of a medication, valproate ( Depakote and Depakote ER), in individuals age 50 years and older who have schizophrenia.
Detailed description
It is known that up to 30% of individuals with schizophrenia continue to have symptoms even when treated with current FDA-approved medications intended to treat their schizophrenia. Anticonvulsant medications such as valproate (Depakote and Depakote ER) are known to be effective for related conditions such as bipolar disorder (manic depressive illness), and are also used by some physicians in clinical settings in combination with antipsychotic medications to treat symptoms of schizophrenia. Currently Depakote and Depakote ER are approved by the FDA to treat bipolar disorder and to treat seizure disorder. This study will test to see if Depakote and Depakote ER may improve symptoms of schizophrenia as well when added to antipsychotic medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| valproate | Experimental | Drug: ValproateAll participants received open-label, add-on valproate. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must have a diagnosis of schizophrenia as confirmed by the MINI
- Must be on antipsychotic medication
- Must be age 50 year or older
- Must be capable of providing written informed consent for study participation. In situations where individuals have guardians of person, guardian and subject must both provide written consent; and
- Must live in the Northeast Ohio area.
Key exclusion criteria (3 listed)
- A primary psychiatric DSM Axis I diagnosis other than schizophrenia
- Actively abusing substances; or
- Medically unstable.
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 |
|---|---|---|
| ValproateAlso: Depakote, Depakote EREnrolled individuals received adjunctive, open-label valproate semisodium, initially started as valproate semisodium delayed -release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended- release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50-100 µg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime. | Drug | valproate |
Primary outcome
Change in Schizophrenia Psychopathology as Assessed by the Positive and Negative Symptom Scale (PANSS)
Time frame: Baseline to 12 weeks
The best and worst possible overall PANSS scores are 30 and 210 units on a scale, respectively.
9 secondary outcomes
Change in Cognitive Status as Measured by the Mini-mental State Examination (MMSE)
Time frame: Baseline to 12 weeks
Change in Overall Functioning as Measured by the Global Assessment Scale (GAS)
Time frame: Baseline to 12 weeks
Change in Depression Symptoms as Measured by the Geriatric Depression Scale (GDS)
Time frame: Baseline to 12 weeks
Change in Overall Mental Health Status as Measure by the Mental Composite Score (MCS) Subscale of the Short Form 36 Health Survey (SF-36)
Time frame: Baseline to 12 weeks
Change in Physical Health Status as Measure by the Physical Composite Score (PCS) Subscale of the Short Form 36 Health Survey (SF-36)
Time frame: Baseline to 12 weeks
Change in Extrapyramidal Symptoms as Assessed by the Abnormal Involuntary Movement Scale (AIMS)
Time frame: Baseline to 12 weeks
Change in Extrapyramidal Symptoms as Assessed by the Simpson Angus Neurological Rating Scale (SAS)
Time frame: Baseline to 12 weeks
Tolerability as Assessed by Weight Change
Time frame: Baseline to 12 weeks
Tolerability as Measured by Mean Serum Level at Study Endpoint
Time frame: Baseline to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17582828Sajatovic M, Coconcea N, Ignacio RV, Blow FC, Hays RW, Cassidy KA, Meyer WJ. Adjunct extended-release valproate semisodium in late life schizophrenia. Int J Geriatr Psychiatry. 2008 Feb;23(2):142-7. doi: 10.1002/gps.1854.
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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.
Martha Sajatovic, MD principal investigator
Case Western Reserve University School of Medicine
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 Valproate in people with Schizophrenia, run by University Hospitals Cleveland 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 5 inclusion and 3 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 6 Jan 2015. 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. 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?
Yes. Results are posted in the registry (first posted 1 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Schizophrenia Psychopathology as Assessed by the Positive and Negative Symptom Scale (PANSS) (time frame: Baseline to 12 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 NCT00194025, 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 6 Jan 2015.