PsychosisEarly Phase 1KLIPSNCT01411566
Clinical Intervention Psychosis and Addiction
A Early Phase 1 study testing Skills trainig for patients with dual diagnosis and regular treatment in people with Psychosis and Substance Abuse, run by University of Cologne at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate an integrative therapeutic concept for schizophrenic patients with comorbid substance use disorder. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Psychosis, Substance Abuse
- What is being tested?
- Skills trainig for patients with dual diagnosis and regular treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Dec 2011
- Phase
- Early Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Schizophrenia
- Addiction
- Written statement of agreement
- Majority
Who cannot join
- Acute psychosis
- Further neuropsychiatric disorder
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
LVR Clinic Cologne - Academic Clinic of the University of Cologne
Cologne, 51109
Joerg Daumann, PhD, +49 221 478 ext. 87113, joerg.daumann@uk-koeln.de
Susanne Koenig, Diploma
About this study
Official title: Evaluation of an Integrative Therapeutic Concept for Schizophrenic Patients With Comorbid Substance Use Disorder
The purpose of this study is to evaluate an integrative therapeutic concept for schizophrenic patients with comorbid substance use disorder.
- Conditions
- Psychosis, Substance Abuse
- Being tested
- Skills trainig for patients with dual diagnosis, regular treatment
- Keywords
- KLIPS
- Medical subject headings
- Psychotic Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skills trainig for patients with dual diagnosisBehavioural
Skills trainig for patients with dual diagnosis
regular treatmentBehavioural
regular treatment
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Behavioral: Skills trainig for patients with dual diagnosis |
| Control | Active comparator | Not described Receives: Behavioral: regular treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance use
Measured: one year
Substance use
Measured: 3 months
Substance use
Measured: 6 months
Change in drug use motivation
Measured: 3 months
Change in drug use motivation
Measured: 6 months
Change in drug use motivation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study startJan 2011
- Primary completionNov 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Investigators
- Joerg Daumann, PhD, Study chair, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411566
- Sponsor's protocol ID
- Koeln-Fortune 104/2010
- Acronym
- KLIPS
- Status last verified
- Feb 2011
- First submitted
- 2 Mar 2011
- Last updated
- 8 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Integrative Therapeutic Concept for Schizophrenic Patients With Comorbid Substance Use Disorder
- ClinicalTrials.gov ID
- NCT01411566
- Acronym / sponsor ID
- KLIPS / Koeln-Fortune 104/2010
- Conditions
- Psychosis, Substance Abuse
- Keywords
- KLIPS
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 8 Aug 2011 (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 evaluate an integrative therapeutic concept for schizophrenic patients with comorbid substance use disorder.
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 |
|---|---|---|
| Treatment | Experimental | Behavioral: Skills trainig for patients with dual diagnosis |
| Control | Active comparator | Behavioral: regular treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Schizophrenia
- Addiction
- Written statement of agreement
- Majority
Key exclusion criteria (2 listed)
- Acute psychosis
- Further neuropsychiatric disorder
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 |
|---|---|---|
| Skills trainig for patients with dual diagnosisSkills trainig for patients with dual diagnosis | Behavioural | Treatment |
| regular treatmentregular treatment | Behavioural | Control |
Primary outcome
Substance use
Time frame: one year
Substance use
Time frame: 3 months
Substance use
Time frame: 6 months
Change in drug use motivation
Time frame: 3 months
Change in drug use motivation
Time frame: 6 months
Change in drug use motivation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2011.
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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.
LVR Clinic Cologne - Academic Clinic of the University of Cologne
Cologne, Germany
Joerg Daumann, PhD study chair
University of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Skills trainig for patients with dual diagnosis and regular treatment in people with Psychosis and Substance Abuse, run by University of Cologne at 1 site in Germany.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Aug 2011. 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 Germany. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Substance use (time frame: one year). 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 8 Aug 2011.