Attention Deficit Hyperactivity DisorderNCT00356070
Treatment of Prisoners With Attention Deficit Hyperactive Disorder in Trondheim Prison
A study testing Strattera in people with Attention Deficit Hyperactivity Disorder, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The treatment of ADHD in jail will help the prisoners in their rehabilitation process Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Strattera
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2006to Dec 2006
- Phase
- Interventional
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All prisoners that fullfill the diagnostic criterias for ADHD -
Who cannot join
- All other prisoners -
Trial locations and contacts
1 site in 1 country.
Norway1 site
St. Olavs Hospital. Departement for forensic psyciatry, Brøset.
Trondheim, 7040
About this study
The treatment of ADHD in jail will help the prisoners in their rehabilitation process
Read the detailed description
Prisoners with ADHD will be offered treatment with Stratera, and we wanted to study their use of the prisons rehabilitation offers as school, programs and work training before and after treatment with Stratera.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Strattera
- Keywords
- Attention Deficit Hyperactivity Disorder, treatment,, Strattera,, rehabilitation
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StratteraDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The symptoms of Attention Deficit Hyperactive Disorders and the prisoners use of the prisons rehabilitation services before and after treatment will be measured
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2006 (estimated)
- Study startJan 2006
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roger Almvik, md phd, Principal investigator, St. Olavs Hospital, Departement of forensic psychiatry, Brøset
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00356070
- Sponsor's protocol ID
- AH 4.2005.147
- Status last verified
- Apr 2017
- First submitted
- 24 Jul 2006
- Last updated
- 28 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Prisoners With Attention Deficit Hyperactive Disorder in Trondheim Prison
- ClinicalTrials.gov ID
- NCT00356070
- Acronym / sponsor ID
- AH 4.2005.147
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder, treatment,, Strattera,, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Jan 2006 (actual)
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 25 Jul 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.
The treatment of ADHD in jail will help the prisoners in their rehabilitation process
Detailed description
Prisoners with ADHD will be offered treatment with Stratera, and we wanted to study their use of the prisons rehabilitation offers as school, programs and work training before and after treatment with Stratera.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All prisoners that fullfill the diagnostic criterias for ADHD -
Key exclusion criteria (1 listed)
- All other prisoners -
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 |
|---|---|---|
| Strattera | Drug | – |
Primary outcome
The symptoms of Attention Deficit Hyperactive Disorders and the prisoners use of the prisons rehabilitation services before and after treatment will be measured
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 28 Apr 2017.
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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.
Roger Almvik, md phd principal investigator
St. Olavs Hospital, Departement of forensic psychiatry, Brøset
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strattera in people with Attention Deficit Hyperactivity Disorder, run by Norwegian University of Science and Technology at 1 site in Norway.
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 1 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 28 Apr 2017. 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 Norway. 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.
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?
The symptoms of Attention Deficit Hyperactive Disorders and the prisoners use of the prisons rehabilitation services before and after treatment will be measured. 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 28 Apr 2017.