Trial | NCT01496690  Report issue

Title

Pregablin for Anxiety-comorbidity in Patients With Schizophrenia
Pregablin for Anxiety-comorbidity in Patients With Schizophrenia - a Double-blinded Randomized Placebo Controlled Study

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    pregabalin ...

  • Study Participants

    54
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 Started
Jan 31
2012
Primary Completion
Dec 31
2016
Study Completion
Dec 31
2016
Last Update
Jan 09
2017
Estimate

Drug Pregabalin

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.

  • Other names: Brand name: Lyrica(R)

Drug Pregabalin Placebo Capsules

Parallel to Active Comparator

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.

Pregabalin Placebo Capsules Placebo Comparator

Criteria 

Inclusion Criteria:

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
Fertile women: Contraception during the trial
S-creatinin within normal reference range
Signed informed consent and power of attorney

Exclusion Criteria:

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
No Results Posted