Trial · NCT00340379

Ziprasidone vs. Sertraline/Haloperidol in Psychotic Depression

NCT00340379, Phase 2, Phase 3, Completed, Duke University; results first posted 2013-06-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Ziprasidone vs. Sertraline/Haloperidol in Psychotic Depression. Trials, record NCT00340379. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00340379

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Ziprasidone vs. Sertraline/Haloperidol in Psychotic Depression
NCT number: NCT00340379
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 72 participants, actual
Lead sponsor: Duke University
Conditions: Affective Disorders
Interventions: Ziprasidone, Sertraline, Haloperidol
First posted: 2006-06-21
Last updated: 2014-08-19
Results first posted: 2013-06-04

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	21 Item Hamilton Depression Rating Scale	12 week	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).
Primary	Clinical Global Impression Improvement Scale	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).
Primary	Brief Psychiatric Rating Scale at 12 Weeks	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.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	21 Item Hamilton Depression Rating Scale	12 week	Number of participants was ITT and imputed by LOCF	Units on Hamilton Depression Scale	MEAN
PRIMARY	Clinical Global Impression Improvement Scale	12 weeks		units on a Clinical Impressions Scale	MEAN
PRIMARY	Brief Psychiatric Rating Scale at 12 Weeks	12 weeks		units on a Psychiatric Rating scale	MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
21 Item Hamilton Depression Rating Scale	Ziprasidone	13.6	Standard Deviation 8.3	Units on Hamilton Depression Scale
21 Item Hamilton Depression Rating Scale	Sertraline/Haloperidol	11.0	Standard Deviation 7.7	Units on Hamilton Depression Scale
Clinical Global Impression Improvement Scale	Ziprasidone	3.1	Standard Deviation 2.0	units on a Clinical Impressions Scale
Clinical Global Impression Improvement Scale	Sertraline/Haloperidol	2.5	Standard Deviation 1.6	units on a Clinical Impressions Scale
Brief Psychiatric Rating Scale at 12 Weeks	Ziprasidone	28.7	Standard Deviation 10.1	units on a Psychiatric Rating scale
Brief Psychiatric Rating Scale at 12 Weeks	Sertraline/Haloperidol	25.8	Standard Deviation 6.5	units on a Psychiatric Rating scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Ziprasidone	35
Overall Study	STARTED	Sertraline/Haloperidol	37
Overall Study	COMPLETED	Ziprasidone	27
Overall Study	COMPLETED	Sertraline/Haloperidol	28
Overall Study	NOT COMPLETED	Ziprasidone	8
Overall Study	NOT COMPLETED	Sertraline/Haloperidol	9

Source ClinicalTrials.gov

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Extrapyramidal symptoms	Nervous system disorders	Ziprasidone	10	35
other	Extrapyramidal symptoms	Nervous system disorders	Sertraline/Haloperidol	15	37
other	Akathisia	Nervous system disorders	Ziprasidone	13	35
other	Akathisia	Nervous system disorders	Sertraline/Haloperidol	8	37
other	Tremors	Nervous system disorders	Ziprasidone	4	35
other	Tremors	Nervous system disorders	Sertraline/Haloperidol	9	37
other	Gastritis	Gastrointestinal disorders	Ziprasidone	8	35
other	Gastritis	Gastrointestinal disorders	Sertraline/Haloperidol	2	37
other	Rigidity	Nervous system disorders	Ziprasidone	4	35
other	Rigidity	Nervous system disorders	Sertraline/Haloperidol	3	37

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ziprasidone
Total, all-cause mortality	Sertraline/Haloperidol
Total, other adverse events	Ziprasidone	28	35
Total, other adverse events	Sertraline/Haloperidol	33	37
Total, serious adverse events	Ziprasidone	1	35
Total, serious adverse events	Sertraline/Haloperidol	0	37

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Ziprasidone vs Sertraline/Haloperidol: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00340379

GET https://conductscience.org/api/trials/v1/NCT00340379/registered

API reference For AI assistants