Aripiprazole Treatment of Bipolar Depression

Bipolar Depression Clinical Trial

Official title:

Open Label Pilot Study of Aripiprazole Treatment of Difficult to Treat Bipolar Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00198198
• Other study ID #: 69883
• Secondary ID: 0402-46
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2005
• Last updated: April 3, 2007
• Start date: August 2005
• Est. completion date: November 2006

Study information

• Verified date: April 2007
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a study of addition of aripirazole to the treatment of bipolar depressed patients who are not better on the medications that they are currently receiving.

Description:

Hypothesis/Objectives:

Aim 1: To investigate whether aripiprazole is effective in the treatment of bipolar depression.

Hypothesis 1: Aripiprazole will lead to a significant decrease in scores on the Hamilton Depression Rating Scale (HAM-D) during an 8-week treatment course.

a. Study Population:

A total number of 10 evaluable patients will be enrolled in the study.

c. Study Design and Method

This proposal will use an open label design. Aripiprazole will be added to the treatment of patients with DSM-IV (American Psychiatric Association, 1994) BDD. Patients will be allowed to continue their psychotropic medication, at a stable dose, as long as they meet inclusion criteria as described below. Aripiprazole will be started at a dose of 10 mg for two weeks, 15 mg for an additional two weeks, and 20 mg for the last four weeks. The length of time a patient stays on the maximum dose (20 mg) depends upon the patient's tolerance and treatment response. Treatment will continue for 8 weeks with weekly visits and ratings on the 17-item Hamilton Depression Rating Scale (HAM-D 17) and other ratings scales.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 1) Male or female between 18 - 65 years of age, inclusive 2) Satisfy DSM-IV criteria for bipolar disorder depressed phase i.e.,duration of depression > 2 weeks) 3) No change in psychotropic medication or their doses within 2 weeks of inclusion in The study. 4) Inadequately responsive to or intolerant of prior pharmacotherapy as determined by the investigator 5) 17-item Hamilton Depression Rating Scale Score > 15 6) Young Mania Rating Scale (Young, et. al., 1978) (YMRS) < 10.

Exclusion Criteria:

Exclusion Criteria: 1) History of or currently suffering from serious medical illness, or be on medication that may interact with aripiprazole 2) On any other neuroleptic e.g., olanzapine, risperidone, ziprasidone, haloperidol.

3) History of substance abuse within 3 months or substance dependence within 6 months of the study. 4) Pregnant or planning to be pregnant or not using adequate contraception. 5) Received electroconvulsive therapy (ECT) treatment in the past 1 year. 6) Significant suicide or homicide risk at the time of the study; 7) Not on any herbal or any other alternative pharmacological treatment. 8) Renal or hepatic dysfunction 9) History of decreased sweating or heat stroke.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

Drug:
• Aripiprazole

Locations

Country	Name	City	State
United States	UH 3124 University Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Scale