Skip to main content
Clinical Trials/IRCT2017013032236N3
IRCT2017013032236N3CompletedPhase 4

Study of the efficacy and safety of aripiprazole as an adjuvant to antipsychotics in patients with residual schizophrenia: A 12-week, randomized, double-blind, placebo-controlled clinical trial

Vice chancellor for research, Mazandaran University of Medical Sciences0 sites50 target enrollmentStarted: TBDLast updated:

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
50

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 years to 65 years (—)
Sex
All

Inclusion Criteria

  • 1- Male or female inpatients in two long-stay Psychiatric Care and Rehabilitation Centers which are Supervised by Iranian Rehabilitation Institute located in Sari in the north of Iran
  • 2-18–65 years at the time of screening
  • 3-With a diagnosis of schizophrenia(paranoid, disorganized, catatonic, or undifferentiated type)or schizoaffective disorder, based on the Structured Clinical Interview for DSM-V and they are suffering from the disease for more than 2 years with residual symptomatology despite antipsychotic treatment
  • 4- All patients are on antipsychotics for at least 1 year and a stable dose for at least 2 month are included in the trial and the antipsychotics dose remain unchanged during the trial.
  • 5-Mood stabilizers (lithium and divalproex) and antidepressants (only the selective serotonine reuptake inhibitors (SSRIs) venlafaxine, and mirtazapine) were permitted as part of antipsychotic pharmacotherapy. Dose of these drugs must be stable for at least 2 month remain unchanged during the trial.
  • Exclusions criteria:
  • 1-Acute relapse (As acute relapse was defined an impending decompensation based on a PANSS score of =4 (moderately) on the subscore items of hostility and uncooperativeness and/or a =20% increase in the PANSS total score.
  • 2-Psychiatric comorbidity(primary or secondary diagnosis of bipolar I disorder, either manic or mixed episode, as defined by DSM-V)
  • 3-History of substance dependence (including alcohol, but excluding nicotine) as defined by DSM-V and relapse within the past 6 months, or substance abuse within the 3 months preceding the trial or positive urine test for illicit drugs
  • 4-Electroconvulsive therapy during the 6 past months
  • 5-Suicidality(active suicide or homicide intent, or a suicide or homicide attempt in the preceding 6 months)
  • 6-Mental retardation
  • 7-Pregnant or at risk of pregnancy
  • 8-Cognitive disorders such as dementia, delirium, or amnesia, traumatic brain injury
  • 9-Current significant unstable medical illness (such as unstable cardiac disease, hepatic or renal impairment, evidence or history of malignancy or any significant hematological, endocrine)/ HIV infection / abnormalities on physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory values
  • 10-Hypersensitivity to aripiprazole
  • 11-Previous treatment with aripiprazole in the past year
  • 12-History of neuroleptic malignant syndrome
  • 13-Unwilling or unable, in the opinion of the Investigator, to comply with study instructions

Exclusion Criteria

  • Not provided

Investigators

Sponsor
Vice chancellor for research, Mazandaran University of Medical Sciences

Similar Trials