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The effect of pregabalin in the treatment of schizophrenia

The effect of adding pregabalin to antipsychotics on positive and negative symptoms in patients with schizophrenia: A randomized placebo-controlled double blind trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015092711885N7
Enrollment
48
Registered
2017-01-03
Start date
2017-12-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia. schizophrenia

Interventions

Intervention 1: twenty-four patients receive pregabalin capsule75 mg/ daily up to 3weeks , then twice a day for 3 weeks next. Intervention 2: 24 patients receive Placebo capsule daily up to 3weeks
Treatment - Drugs
twenty-four patients receive pregabalin capsule75 mg/ daily up to 3weeks , then twice a day for 3 weeks next
24 patients receive Placebo capsule daily up to 3weeks then twice a day for next 3weeks

Sponsors

Vice chancellor for research, Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Diagnosis of schizophrenia according to DSM-V criteria by psychiatrist 2. Age 18 to 65 years 3. Informed consent / guardian for inclusion 4. Treatment with antipsychotics 5. Refractory schizophrenia Exclusion criteria: 1. Other psychiatric disorders axis I or II exist 2. Serious or chronic diseases like renal and liver dysfunction, severe diarrhea, cardiovascular disease, urinary tract infection, head injury 3. Pregnancy 4. Breastfeeding 5. Lack of appropriate contraception in women of reproductive age 6. Substance abuse over the past month 7. Intolerable side effects 8. History of allergy to Pregabalin 9. Change the doses of antipsychotic agents during last two weeks 10. Patient/ guardian’s apply to withdraw from the study

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Positive and negative symptom of schizophrenia. Timepoint: Before intervention, three weeks after beginning intervention, the end of intervention. Method of measurement: Positive_and_Negative_Syndrome_Scale.

Secondary

MeasureTime frame
Extra pyramidal syndrome. Timepoint: Before intervention, three weeks after beginning intervention, the end of intervention. Method of measurement: Abnormal-Involuntary-Movement-Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactElham mahtiyan

Medical science of mazandaran university

E_mahtiyan@yahoo.com+98 11 3328 3886

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026