Trial Outcomes & Findings for Ziprasidone for the Treatment of Generalized Anxiety in Patients With Bipolar Disorder (NCT NCT00374543)

NCT ID: NCT00374543

Last Updated: 2014-04-16

Results Overview

The 14-item Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1959) was developed to assess anxiety in a clinical population. It is considered a measure of general anxiety across anxiety disorders, in addition to being a gold standard measure for GAD. Due to study termination, there are not results for primary and secondary outcome measures.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 3 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2014-04-16

Participant Flow

Numerous attempts were made to increase enrollment since study inception. Researchers made use of Radio, Internet and print ads, as well as weekly Internet postings. Researchers also circulated an IRB-approved GAD checklist in a Bipolar Clinic waiting area in order to increase enrollment and recruit a clinically relevant sample.

A total of thirteen individuals signed consent, but only three were randomized to the study arms. The other ten participants were excluded from the study for meeting various exclusion criteria.

Participant milestones

Measure	Ziprasidone, 40 to 160 mg/Day Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Ziprasidone will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.	Placebo Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Identical placebo capsules will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
Overall Study STARTED	2	1
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ziprasidone for the Treatment of Generalized Anxiety in Patients With Bipolar Disorder

Baseline characteristics by cohort

Measure	Ziprasidone, 40 to 160 mg/Day n=2 Participants Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Ziprasidone will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.	Placebo n=1 Participants Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Identical placebo capsules will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.	Total n=3 Participants Total of all reporting groups
Age, Customized <18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized >= 18 to 75 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Customized >75 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Zero participants were analyzed because recruitment was very low. Due to this, we felt any analysis done would not be usable for accurate analyses.

The 14-item Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1959) was developed to assess anxiety in a clinical population. It is considered a measure of general anxiety across anxiety disorders, in addition to being a gold standard measure for GAD.

Due to study termination, there are not results for primary and secondary outcome measures.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

A secondary categorical outcome of response will be defined as a Clinical Global Impression Improvement Score (CGI-I) of 1 or 2. The CGI-I is a 7 point clinician-rated scale that assesses symptom improvement or worsening relative to a previous assessment. Lower ratings reflect greater improvement.

Due to study termination, there are not results for primary and secondary outcome measures.

Outcome measures

Outcome data not reported

Adverse Events

Ziprasidone, 40 to 160 mg/Day

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ziprasidone, 40 to 160 mg/Day n=2 participants at risk Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Ziprasidone will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.	Placebo n=1 participants at risk Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Identical placebo capsules will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
General disorders Tremulousness	50.0% 1/2 • Number of events 1	0.00% 0/1
General disorders Chills	50.0% 1/2 • Number of events 1	0.00% 0/1
General disorders Urinary Hesitancy	50.0% 1/2 • Number of events 1	0.00% 0/1
General disorders Dry Mouth	50.0% 1/2 • Number of events 3	0.00% 0/1
General disorders Akathisia	50.0% 1/2 • Number of events 2	0.00% 0/1
General disorders Jitteriness	50.0% 1/2 • Number of events 1	0.00% 0/1

Additional Information

Naomi M. Simon, M.D., M.Sc.

Massachusetts General Hospital

Phone: (617) 726-7913

Email: nsimon@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place