Trial Outcomes & Findings for Ziprasidone vs. Sertraline/Haloperidol in Psychotic Depression (NCT NCT00340379)

Last Updated: 2014-08-19

Results Overview

The scale rates 21 symptoms related to major depression. A total score of 0-7 is considered to be normal, scores of 20 or higher indicate moderately severe depression. Total scores range from a minimum of 0(not ill) to a maximum of 64 (severely ill).

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

72 participants

Primary outcome timeframe

12 week

Results posted on

2014-08-19

Participant Flow

Participant milestones

Participant milestones
Measure	Ziprasidone Target dosage of 120-160mg/day based on tolerance.	Sertraline/Haloperidol Target dosage of 150-200mg/day for sertraline and 6-8mg/day for haloperidol.
Overall Study STARTED	35	37
Overall Study COMPLETED	27	28
Overall Study NOT COMPLETED	8	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ziprasidone vs. Sertraline/Haloperidol in Psychotic Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ziprasidone n=35 Participants	Sertraline/Haloperidol n=37 Participants	Total n=72 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants	37 Participants n=7 Participants	72 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	36.4 years STANDARD_DEVIATION 8.7 • n=5 Participants	35.9 years STANDARD_DEVIATION 12.0 • n=7 Participants	36.1 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	17 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment Egypt	14 participants n=5 Participants	15 participants n=7 Participants	29 participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	5 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment India	18 participants n=5 Participants	17 participants n=7 Participants	35 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 week

Population: Number of participants was ITT and imputed by LOCF

Outcome measures

Outcome measures
Measure	Ziprasidone n=35 Participants	Sertraline/Haloperidol n=37 Participants
21 Item Hamilton Depression Rating Scale	13.6 Units on Hamilton Depression Scale Standard Deviation 8.3	11.0 Units on Hamilton Depression Scale Standard Deviation 7.7

PRIMARY outcome

Timeframe: 12 weeks

A 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. Overall the scale goes from a minimum of 1(very much improved) to a maximum of 7(very much worse).

Outcome measures

Outcome measures
Measure	Ziprasidone n=35 Participants	Sertraline/Haloperidol n=37 Participants
Clinical Global Impression Improvement Scale	3.1 units on a Clinical Impressions Scale Standard Deviation 2.0	2.5 units on a Clinical Impressions Scale Standard Deviation 1.6

PRIMARY outcome

Timeframe: 12 weeks

A rating scale used to measure psychiatric symptoms such as depression, anxiety, hallucinations and unusual behaviour. Each symptom is rated 1-7 and in this version a total of 24 symptoms are scored. Thus the total range of scores is from a minimum of 24 to a maximum of 168. Lower scores are considered better, so the minimum total score of 24 indicates someone with no psychiatric symptoms, while any score over 40 is considered at least moderately severe, with only the most severely ill patients scoring over 60.

Outcome measures

Outcome measures
Measure	Ziprasidone n=35 Participants	Sertraline/Haloperidol n=37 Participants
Brief Psychiatric Rating Scale at 12 Weeks	28.7 units on a Psychiatric Rating scale Standard Deviation 10.1	25.8 units on a Psychiatric Rating scale Standard Deviation 6.5

Adverse Events

Ziprasidone

Serious events: 1 serious events

Other events: 28 other events

Deaths: 0 deaths

Sertraline/Haloperidol

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ziprasidone n=35 participants at risk	Sertraline/Haloperidol n=37 participants at risk
General disorders Death	2.9% 1/35 • Number of events 1	0.00% 0/37

Other adverse events

Other adverse events
Measure	Ziprasidone n=35 participants at risk	Sertraline/Haloperidol n=37 participants at risk
Nervous system disorders Extrapyramidal symptoms	28.6% 10/35	40.5% 15/37
Nervous system disorders Akathisia	37.1% 13/35	21.6% 8/37
Nervous system disorders Tremors	11.4% 4/35	24.3% 9/37
Gastrointestinal disorders Gastritis	22.9% 8/35	5.4% 2/37
Nervous system disorders Rigidity	11.4% 4/35	8.1% 3/37

Additional Information

Frederick Cassidy

Duke University

Phone: 919-575-7801

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place