SchizophreniaPhase 4PACSNCT01496690
Pregablin for Anxiety-comorbidity in Patients With Schizophrenia
A Phase 4 study testing Pregabalin in people with Schizophrenia and Anxiety-comorbidity to Schizophrenia, run by University of Aarhus at 1 site in Denmark.
Trial summary
The PACS study aims to investigate the efficacy and tolerability of pregabalin for schizophrenic patients that suffer from comorbid anxiety. The study design is an 8 week flexible dosage, randomized placebo controlled. The study population is patients diagnosed with ICD-10 schizophrenia and age 18-65. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Anxiety-comorbidity to Schizophrenia
- What is being tested?
- Pregabalin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2012to Dec 2016
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-65 years
- An ICD-10 schizophrenia diagnosis F20.0-20.3 or F20.9
- Stable dosage of psychotropic 4 weeks before inclusion
- Hamilton Anxiety Scale total score > 15
- Positive and Negative Syndrome Scale for Schizophrenia total score < 70
- The Calgary Depression Scale for Schizophrenia total score < 10
Show all 9Show fewer
- Fertile women: Contraception during the trial
- S-creatinin within normal reference range
- Signed informed consent and power of attorney
Who cannot join
- Significant substance abuse
- QTc > 480 milliseconds
- Severe dysregulated diabetes
- For women: Pregnancy or breast-feeding
- Confinement in accordance with the Danish Law of Psychiatry
- Concrete suicidally
- Known hypersensitivity or allergic reaction to the active ingredient of the drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pregablin for Anxiety-comorbidity in Patients With Schizophrenia - a Double-blinded Randomized Placebo Controlled Study
The PACS study aims to investigate the efficacy and tolerability of pregabalin for schizophrenic patients that suffer from comorbid anxiety.
The study design is an 8 week flexible dosage, randomized placebo controlled.
The study population is patients diagnosed with ICD-10 schizophrenia and age 18-65. Patients are recruited from outpatient clinics from entire Denmark.
- Being tested
- Pregabalin, Pregabalin Placebo Capsules
- Keywords
- Anxiety-comorbidity to schizophrenia, Double-blinded randomized placebo controlled trial, Pregabalin
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Brand name: Lyrica(R)
Subjects are randomized 1:1 to either pregabalin treatment or placebo. The intervention period is 8 weeks. The daily pregabalin dose is 75 mg. during the first week followed by 7 weeks of flexible daily dosing (150, 300, 450 or 600 mg.) depending on tolerability and response. Doses above 150 mg. should be divided in two daily dosages.
Pregabalin Placebo CapsulesDrug
Parallel to Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| pregabalin | Active comparator | The pregabalin dose is 75 mg daily the first week followed by 7 weeks of flexible daily dosing (150, 300, 450 or 600 mg.) depending on tolerability and response. Receives: Drug: Pregabalin |
| Pregabalin Placebo Capsules | Placebo comparator | Not described Receives: Drug: Pregabalin Placebo Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Anxiety Scale
Measured: Baseline - 4 weeks treatment - 8 weeks treatment
Secondary outcomes (1)
UKU-Overall adverse effect scale
Measured: Baseline - 4 weeks treatment - 8 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Albert Einstein College of Medicine, GCP-unit at Aarhus University Hospital, Aarhus, Denmark, The Hospital Pharmcacy North Denmark Region, Denmark, Pfizer
- Responsible party
- Sponsor
- Investigators
- Ole Schjerning, M.D., Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496690
- Sponsor's protocol ID
- Eudra CT nr 2010-024488-42
- Other IDs
- N-20100097
- Acronym
- PACS
- Status last verified
- Jan 2017
- First submitted
- 19 Dec 2011
- Last updated
- 9 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregablin for Anxiety-comorbidity in Patients With Schizophrenia - a Double-blinded Randomized Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT01496690
- Acronym / sponsor ID
- PACS / Eudra CT nr 2010-024488-42
- Keywords
- Anxiety-comorbidity to schizophrenia, Double-blinded randomized placebo controlled trial, Pregabalin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Albert Einstein College of Medicine, GCP-unit at Aarhus University Hospital, Aarhus, Denmark, The Hospital Pharmcacy North Denmark Region, Denmark, Pfizer
- Study start
- Jan 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Dec 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 PACS study aims to investigate the efficacy and tolerability of pregabalin for schizophrenic patients that suffer from comorbid anxiety.
The study design is an 8 week flexible dosage, randomized placebo controlled.
The study population is patients diagnosed with ICD-10 schizophrenia and age 18-65. Patients are recruited from outpatient clinics from entire Denmark.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregabalin | Active comparator | Drug: PregabalinThe pregabalin dose is 75 mg daily the first week followed by 7 weeks of flexible daily dosing (150, 300, 450 or 600 mg.) depending on tolerability and response. |
| Pregabalin Placebo Capsules | Placebo comparator | Drug: Pregabalin Placebo Capsules |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ages 18-65 years
- An ICD-10 schizophrenia diagnosis F20.0-20.3 or F20.9
- Stable dosage of psychotropic 4 weeks before inclusion
- Hamilton Anxiety Scale total score > 15
- Positive and Negative Syndrome Scale for Schizophrenia total score < 70
Key exclusion criteria (7 listed)
- Significant substance abuse
- QTc > 480 milliseconds
- Severe dysregulated diabetes
- For women: Pregnancy or breast-feeding
- Confinement in accordance with the Danish Law of Psychiatry
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 |
|---|---|---|
| PregabalinAlso: Brand name: Lyrica(R)Subjects are randomized 1:1 to either pregabalin treatment or placebo. The intervention period is 8 weeks. The daily pregabalin dose is 75 mg. during the first week followed by 7 weeks of flexible daily dosing (150, 300, 450 or 600 mg.) depending on tolerability and response. Doses above 150 mg. should be divided in two daily dosages. | Drug | pregabalin |
| Pregabalin Placebo CapsulesParallel to Active Comparator | Drug | Pregabalin Placebo Capsules |
Primary outcome
Hamilton Anxiety Scale
Time frame: Baseline - 4 weeks treatment - 8 weeks treatment
1 secondary outcome
UKU-Overall adverse effect scale
Time frame: Baseline - 4 weeks treatment - 8 weeks treatment
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 9 Jan 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.
Ole Schjerning, M.D. principal investigator
Aalborg University Hospital
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 Pregabalin in people with Schizophrenia and Anxiety-comorbidity to Schizophrenia, run by University of Aarhus at 1 site in Denmark.
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 9 inclusion and 7 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 9 Jan 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 Denmark. 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 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?
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?
Hamilton Anxiety Scale (time frame: Baseline - 4 weeks treatment - 8 weeks treatment). 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 9 Jan 2017; AzTrials last refreshed its copy on 7 Nov 2026.