Palmitoylethanolamide as adjuvant therapy in the treatment of negative symptoms in patients with chronic schizophrenia: A randomized double blind and placebo controlled clinical trial
The effect of Palmitoylethanolamide on the treatment of negative symptoms in patients with chronic schizophrenia
Design
Randomized double blind and placebo-controlled clinical trial
Settings and conduct
The study will be performed on patients with chronic schizophrenia attending Roozbeh Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18 to 60 years old; take Risperidone for at least 4 weeks at the dose of 4-6 mg/day before entering the study; the positive and acute symptoms of patients should be stable. Exclusion criteria: head trauma; history of shock therapy during past three months prior to the trial; undergoing neurosurgery; presence of acute or chronic systemic diseases; history of allergy to Cilostazol.
Intervention groups
Patients with chronic schizophrenia (based on DSM-5 diagnostic criteria) are included in the study and divided into two control groups (25 participants) and intervention (25 participants). Patients in the intervention group receive Palmitoylethanolamide capsules for eight weeks, and patients in the control group receive placebo for eight weeks. Using Positive and Negative Symptoms Scale (PANSS), patients' negative symptoms are evaluated at weeks 0, 4 and 8.
Main outcome variables
Severity of schizophrenia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090117001556N127
Registration date:2020-05-18, 1399/02/29
Registration timing:prospective
Last update:2020-05-18, 1399/02/29
Update count:0
Registration date
2020-05-18, 1399/02/29
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Palmitoylethanolamide as adjuvant therapy in the treatment of negative symptoms in patients with chronic schizophrenia: A randomized double blind and placebo controlled clinical trial
Public title
The effect of Palmitoylethanolamide on the treatment of negative symptoms in patients with chronic schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 60 years
Take Risperidone for at least 4 weeks at the dose of 4-6 mg/day before entering the study
The positive and acute symptoms of patients should be stable
Exclusion criteria:
Head trauma
History of shock therapy during past three months prior to the trial
Undergoing neurosurgery
Presence of acute or chronic systemic diseases
History of allergy to Cilostazol
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization: using A and B blocks with n=4; AABB, ABAB, ABBA, BABA, BAAB, BBAA. We randomly use the blocks to achieve total sample size. ("A" and "B" are the study groups)
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, care providers and outcome assessors will be blind regarding grouping. All the participants believe that they are taking the main medication (the participants who are taking placebo are not aware of it). Care providers and outcome assessors do not know which participants have received the main medication and which participants have received placebo. Thus, there is no orientation in their work process.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Qhods St., Keshavarz Blvd.