Reversal of Antipsychotic-Induced Hyperprolactinemia, Weight Gain, Hyperglycemia and Dyslipidemia

NCT00541554 | Unknown Phase 4

• 1 other identifier: 31-06-P05
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, open-label study to evaluate the efficacy and safety in reducing antipsychotic-induced hyperprolactinemia, weight gain, and dyslipidemia by aripiprazole. Approximate 60 patients will be recruited to achieve at least 40 evaluable patients.

Conditions

Hyperprolactinemia; Weight Gain; Dyslipidemia

Interventions

Abilify (aripiprazole) DRUG

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female in age between 12 and 65 years old.
• Clinical diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder with DSM-IV criteria.
• Keep stable dosage of the same antipsychotic other than aripiprazole during last one month.
• Who are currently taking antipsychotic drugs and for whom an alteration in medication is clinically reasonable. This includes patients who are stable or who have symptoms that are not optimally controlled or patients experiencing tolerability problems.
• Having antipsychotic-induced symptomatic hyperprolactinemia, weight gain, increased plasma glucose or dyslipidemia judged by the investigator.
• Informed Consent was obtained from the subject and legal guardian (if necessary).

You may not qualify if:

• Pregnant or breast feeding women or planning a pregnancy.
• Patient has a history of hypersensitivity or allergy to investigated drug.
• Acute psychosis, acute suicidal ideation, or any acute psychiatric condition that might require emergent intervention.
• Any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the study treatment.
• Having participated other investigational drug study and taken the investigation drug within one month prior to study entry.

Sponsors & Collaborators

• Genovate Biotechnology Co., Ltd.,: lead

Related Publications (1)

• Chen CK, Huang YS, Ree SC, Hsiao CC. Differential add-on effects of aripiprazole in resolving hyperprolactinemia induced by risperidone in comparison to benzamide antipsychotics. Prog Neuropsychopharmacol Biol Psychiatry. 2010 Dec 1;34(8):1495-9. doi: 10.1016/j.pnpbp.2010.08.012. Epub 2010 Aug 20.

  PMID: 20732372 DERIVED

MeSH Terms

Conditions

Hyperprolactinemia; Weight Gain; Dyslipidemias

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Chen Chih-Ken, PhD

  Chang Gung Memorial Hospital, Keelung, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen Chih-Ken, PhD

CONTACT

+886-2-24313131; kenchen@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 8, 2007
• First Posted: October 10, 2007
• Study Start: October 1, 2007
• Study Completion: February 1, 2009
• Last Updated: October 10, 2007

Record last verified: 2007-10