Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia

NCT02013232 | Unknown DMC

• 1 other identifier: ARI201206
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Hyperprolactinemia is a frequent consequence of treatment with typical antipsychotic agents and atypical antipsychotics such as risperidone. Recent studies have suggested that aripiprazole, a partial dopamine agonist, reduces the prolactin response to antipsychotics. Thus, we conducted this study to evaluate the dose effects of adjunctive treatment with aripiprazole on hyperprolactinemia in stable schizophrenic patients maintained with risperidone.

Conditions

Schizophrenia

Keywords

Risperidone;; Aripiprazole;; Hyperprolactinemia;; dose effects

Outcome Measures

Primary Outcomes (1)

• Prolactin level

  Change from baseline in the levels of prolactin

  baseline, 2 weeks, 4 weeks, 8 weeks

Secondary Outcomes (1)

• PANSS (positive and negative syndrome scale) score

  Baseline, 8 weeks

Other Outcomes (1)

• extrapyramidal symptoms

  baseline, 4 weeks, 8 weeks

Study Arms (4)

placebo

PLACEBO COMPARATOR

risperidone plus placebo

aripiprazole 5mg

EXPERIMENTAL

risperidone treatment plus aripiprazole 5mg/day

Drug: Aripiprazole

aripiprazole 10mg

EXPERIMENTAL

risperidone plus aripiprazole 10mg/day

Drug: Aripiprazole

aripiprazole 20mg

EXPERIMENTAL

risperidone plus aripiprazole 20mg/day

Drug: Aripiprazole

Interventions

Aripiprazole DRUG

aripiprazole 10mg; aripiprazole 20mg; aripiprazole 5mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• aged 18-45 years of and fulfilled Diagnostic and Statistical Manual of Mental Disorders(DSM-IV )criteria (American Psychiatric Association, 1994) for schizophrenia;
• having a stable psychiatric condition, defined as taking the same dosage of risperidone for at least 6 weeks;
• being treated with risperidone monotherapy; and presence of hyperprolactinemia associated with risperidone.

You may not qualify if:

• any other major psychiatric disorder;
• significant concurrent medical illnesses, organic brain disorder, history of substance and alcohol abuse, and mental retardation

Sponsors & Collaborators

• Beijing HuiLongGuan Hospital: lead

Study Sites (1)

Beijing HuiLongGuan Hospital

Beijing, Beijing Municipality, 102208, China

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Hyperprolactinemia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Jingxu Chen, master

CONTACT

86-13681394260; chenjx1110@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 17, 2013
• Study Start: February 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2014
• Last Updated: December 17, 2013

Record last verified: 2013-12

Locations

CN (1)