Schizoaffective DisorderPhase 2NCT00018629
Cognitive - Behavioral Therapy
A Phase 2 study of Schizoaffective Disorder and Schizophrenia, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to determine if Cognitive - Behavioral Social Skills Training (CBSST) improves functioning in older patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Schizoaffective Disorder, Schizophrenia
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- May 2000to Apr 2005
- Phase
- Phase 2
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be 45 years of age or older with a diagnosis of schizophrenia or schizoaffective disorder.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego
San Diego, California, 92161
About this study
Official title: Rehabilitation of Older Patients With Schizophrenia
The purpose of this study is to determine if Cognitive - Behavioral Social Skills Training (CBSST) improves functioning in older patients with schizophrenia.
Read the detailed description
This is a randomized-control clinical trial. After completion the baseline assessment, subjects will be randomly assigned to either standard pharmacotherapy or SP+CBSST and will be followed for 18 months. The subjects will be 180 outpatients over the age of 45 with a diagnosis of schizophrenia or schizoaffective disorder.
- Conditions
- Schizoaffective Disorder, Schizophrenia
- Keywords
- Aging, Neuropsychology, Psychotherapy, Rehabilitation, Schizophrenia
- Medical subject headings
- Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2001 (estimated)
- Study startMay 2000
- Primary completionApr 2005
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizoaffective DisorderStudies 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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Eric L. Granholm, PhD, Principal investigator, VA San Diego Healthcare System, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00018629
- Sponsor's protocol ID
- MHBS-043-99S
- Status last verified
- Sep 2008
- First submitted
- 3 Jul 2001
- Last updated
- 7 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Older Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00018629
- Acronym / sponsor ID
- MHBS-043-99S
- Conditions
- Schizoaffective Disorder, Schizophrenia
- Keywords
- Aging, Neuropsychology, Psychotherapy, Rehabilitation, Schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- May 2000
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 5 Jul 2001 (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 if Cognitive - Behavioral Social Skills Training (CBSST) improves functioning in older patients with schizophrenia.
Detailed description
This is a randomized-control clinical trial. After completion the baseline assessment, subjects will be randomly assigned to either standard pharmacotherapy or SP+CBSST and will be followed for 18 months. The subjects will be 180 outpatients over the age of 45 with a diagnosis of schizophrenia or schizoaffective disorder.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients must be 45 years of age or older with a diagnosis of schizophrenia or schizoaffective disorder.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Other | – |
Primary outcome
Not reported in the source record.
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 7 Jan 2009.
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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.
Eric L. Granholm, PhD principal investigator
VA San Diego Healthcare System, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Schizoaffective Disorder and Schizophrenia, run by US Department of Veterans Affairs 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 1 inclusion and 0 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 7 Jan 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
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 7 Jan 2009.