Trial Outcomes & Findings for Ziprasidone in Bipolar Disorder With Comorbid Lifetime Panic or Generalized Anxiety Disorder(GAD) (NCT NCT01172652)

NCT ID: NCT01172652

Last Updated: 2025-04-08

Results Overview

CGI-21 Anxiety Scale ranges from -10 (Very Bad. Could not be worse) to +10 (Major Improvement. Back to normal self).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 49 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2025-04-08

Participant Flow

Participant milestones

Measure	Ziprasidone Ziprasidone in the form of 40 and/or 80 mg capsules. Dose range: 40 to 160 mg/day.	Placebo Administered in capsules identical to the ziprasidone capsules.
Overall Study STARTED	25	24
Overall Study COMPLETED	6	17
Overall Study NOT COMPLETED	19	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ziprasidone in Bipolar Disorder With Comorbid Lifetime Panic or Generalized Anxiety Disorder(GAD)

Baseline characteristics by cohort

Measure	Ziprasidone n=25 Participants Ziprasidone in the form of 40 and/or 80 mg capsules. Dose range: 40 to 160 mg/day.	Placebo n=24 Participants Administered in capsules identical to the ziprasidone capsules.	Total n=49 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=93 Participants	24 Participants n=4 Participants	49 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	37.7 years STANDARD_DEVIATION 17.7 • n=93 Participants	34.6 years STANDARD_DEVIATION 12.2 • n=4 Participants	36.1 years STANDARD_DEVIATION 15.2 • n=27 Participants
Sex: Female, Male Female	19 Participants n=93 Participants	17 Participants n=4 Participants	36 Participants n=27 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	7 Participants n=4 Participants	13 Participants n=27 Participants
Region of Enrollment United States	25 participants n=93 Participants	24 participants n=4 Participants	49 participants n=27 Participants

PRIMARY outcome

Timeframe: 8 weeks

CGI-21 Anxiety Scale ranges from -10 (Very Bad. Could not be worse) to +10 (Major Improvement. Back to normal self).

Outcome measures

Measure	Ziprasidone n=25 Participants Ziprasidone in the form of 40 and/or 80 mg capsules. Dose range: 40 to 160 mg/day. Ziprasidone: The minimum dose during study participation will be 40 mg/day, and the maximum dose allowed will be 160 mg/day.	Placebo n=24 Participants Administered in capsules identical to the ziprasidone capsules. Placebo: Inactive control
Clinician Global Improvement Scale (CGI-21)	7.8 units on a scale Standard Deviation 1.7	3.4 units on a scale Standard Deviation 4.5

SECONDARY outcome

Timeframe: 8 weeks

Scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

Outcome measures

Measure	Ziprasidone n=25 Participants Ziprasidone in the form of 40 and/or 80 mg capsules. Dose range: 40 to 160 mg/day. Ziprasidone: The minimum dose during study participation will be 40 mg/day, and the maximum dose allowed will be 160 mg/day.	Placebo n=24 Participants Administered in capsules identical to the ziprasidone capsules. Placebo: Inactive control
Hamilton Anxiety Rating Scale (HAM-A)	10.2 units on a scale Standard Deviation 6.6	13.1 units on a scale Standard Deviation 10.4

SECONDARY outcome

Timeframe: 8 weeks

Four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. There are well described anchor points for each grade of severity. The authors encourage the use of whole or half point ratings once experience with the scale is acquired. Typical YMRS baseline scores can vary a lot. The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania).

Outcome measures

Measure	Ziprasidone n=25 Participants Ziprasidone in the form of 40 and/or 80 mg capsules. Dose range: 40 to 160 mg/day. Ziprasidone: The minimum dose during study participation will be 40 mg/day, and the maximum dose allowed will be 160 mg/day.	Placebo n=24 Participants Administered in capsules identical to the ziprasidone capsules. Placebo: Inactive control
Young Mania Rating Scale	4.2 units on a scale Standard Deviation 5.1	4.4 units on a scale Standard Deviation 4.8

SECONDARY outcome

Timeframe: 8 weeks

Ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts. Usual cutoff points are: 0 to 6 - normal /symptom absent; 7 to 19 - mild depression; 20 to 34 moderate depression; >34 - severe depression.

Outcome measures

Measure	Ziprasidone n=25 Participants Ziprasidone in the form of 40 and/or 80 mg capsules. Dose range: 40 to 160 mg/day. Ziprasidone: The minimum dose during study participation will be 40 mg/day, and the maximum dose allowed will be 160 mg/day.	Placebo n=24 Participants Administered in capsules identical to the ziprasidone capsules. Placebo: Inactive control
Montgomery-Asberg Depression Rating Scale (MADRS)	17.3 units on a scale Standard Deviation 11.5	19.1 units on a scale Standard Deviation 10.1

SECONDARY outcome

Timeframe: 8 weeks

A guide for rating severity of manic and depressive episodes and the degree of change from the immediately preceding phase and from the worst phase of illness. Provides a set of instructions to facilitate the reliability of these ratings of mania, depression, and overall bipolar illness during treatment of an acute episode or in longer-term illness prophylaxis. Comprises two companion one-item measures evaluating the following:(a) severity of psychopathology from 1 to 7 and (b) change from the initiation of treatment on a similar seven-point scale. The minimum value in each category is a score of 1 (indicating 'normal' or 'not ill') and the maximum value is a score of 7 (indicating 'very severely ill'). Higher scores indicate a worse outcome due to greater severity of bipolar symptoms. 1 = Very much improved 5 = Minimally worse 2 = Much improved 6 = Much worse 3 = Minimally improved 7 = Very much worse 4 = No change 3. Efficacy Index Rate this item on the basis of drug effect only.

Outcome measures

Measure	Ziprasidone n=25 Participants Ziprasidone in the form of 40 and/or 80 mg capsules. Dose range: 40 to 160 mg/day. Ziprasidone: The minimum dose during study participation will be 40 mg/day, and the maximum dose allowed will be 160 mg/day.	Placebo n=24 Participants Administered in capsules identical to the ziprasidone capsules. Placebo: Inactive control
CGI-BP	3.0 units on a scale Standard Deviation 1.5	3.0 units on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: 8 weeks

A composite of three self-rated items designed to measure the extent to which three major sectors in the patient's life are impaired by panic, anxiety, phobic, or depressive symptoms. Patient rates the extent to which his or her 1) work, 2) social life or leisure activities, and 3) home life or family responsibilities are impaired by his or her symptoms on a 10-point visual analog scale. In each sector of the overall scale, the minimum score is a 1 (indicating that symptoms have been 'not at all' disruptive to functioning) and the maximum score is a 10 (indicating that symptoms have been 'extremely' disruptive to functioning). Each area of functioning is rated on a scale of 0 to either 3 or 5 (maximum score = 29-extreme vegetative state, minimum score = 0-person without disability) with the highest scores representing the higher level of disability. Higher scores indicate a worse outcome stemming from greater disability/impairment.

Outcome measures

Measure	Ziprasidone n=25 Participants Ziprasidone in the form of 40 and/or 80 mg capsules. Dose range: 40 to 160 mg/day. Ziprasidone: The minimum dose during study participation will be 40 mg/day, and the maximum dose allowed will be 160 mg/day.	Placebo n=24 Participants Administered in capsules identical to the ziprasidone capsules. Placebo: Inactive control
Sheehan Disability Scale (SDS)	5 units on a scale Standard Deviation 4	9.9 units on a scale Standard Deviation 10.0

SECONDARY outcome

Timeframe: 8 Weeks

Population: Outpatients with lifetime bipolar I disorder, bipolar II disorder, or bipolar disorder NOS by DSM-IV-TR criteria (26), who have co-morbid lifetime panic or generalized anxiety disorder, whose bipolar symptoms are no worse than moderately severe, and whose anxiety symptoms are currently at least moderately severe.

SIS consists of seven items that assess symptoms of irritability, frustration, edginess/impatience, moodiness, anger with self, anger with others and temper during the previous week. Each item is assessed on an 11-point numeric rating scale ranging from 0 (not at all) to 10 (extremely). The SIS total score is calculated by summing of the scores for each of the seven individual items and ranges from 0 to 70. A higher score indicates a higher rate of irritability symptoms and therefore, a worse outcome.

Outcome measures

Measure	Ziprasidone n=25 Participants Ziprasidone in the form of 40 and/or 80 mg capsules. Dose range: 40 to 160 mg/day. Ziprasidone: The minimum dose during study participation will be 40 mg/day, and the maximum dose allowed will be 160 mg/day.	Placebo n=24 Participants Administered in capsules identical to the ziprasidone capsules. Placebo: Inactive control
Sheehan Irritability Scale (SIS)	25 Participants	24 Participants

Adverse Events

Ziprasidone

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ziprasidone n=25 participants at risk Ziprasidone in the form of 40 and/or 80 mg capsules. Dose range: 40 to 160 mg/day.	Placebo n=24 participants at risk Administered in capsules identical to the ziprasidone capsules.
Social circumstances Hospitilazation	0.00% 0/25 • Adverse events were collected throughout the whole duration of the study which was 4/10 until 6/16. Each participant's adverse events were collected during the period of their participation up to	4.2% 1/24 • Number of events 1 • Adverse events were collected throughout the whole duration of the study which was 4/10 until 6/16. Each participant's adverse events were collected during the period of their participation up to
Psychiatric disorders Increase mood symptoms	4.0% 1/25 • Number of events 1 • Adverse events were collected throughout the whole duration of the study which was 4/10 until 6/16. Each participant's adverse events were collected during the period of their participation up to	0.00% 0/24 • Adverse events were collected throughout the whole duration of the study which was 4/10 until 6/16. Each participant's adverse events were collected during the period of their participation up to

Other adverse events

Adverse event data not reported

Additional Information

Dr. Trisha Suppes, MD PhD

VA Palo Alto Health Care System

Phone: (650) 493-5000

Email: tsuppes@va.gov

Results disclosure agreements

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