Trial · NCT00555997

A 12-Week, Placebo Controlled Trial of Ziprasidone as Monotherapy for Major Depressive Disorder

NCT00555997, Phase 2, Completed, Massachusetts General Hospital; results first posted 2014-07-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A 12-Week, Placebo Controlled Trial of Ziprasidone as Monotherapy for Major Depressive Disorder. Trials, record NCT00555997. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00555997

On this page

Trial

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

Title: A 12-Week, Placebo Controlled Trial of Ziprasidone as Monotherapy for Major Depressive Disorder
NCT number: NCT00555997
Status: Completed
Phases: Phase 2
Enrollment: 120 participants, actual
Lead sponsor: Massachusetts General Hospital
Conditions: Major Depressive Disorder
Interventions: Ziprasidone, Ziprasidone, Placebo
First posted: 2007-11-09
Last updated: 2014-07-03
Results first posted: 2014-07-03

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Hamilton Depression Rating Scale (HAM-D-17) Scores	6 weeks	Higher numbers represent more symptoms of a major depressive episode. Minimum is 0. Maximum is 52.
Secondary	Responder/Non-responder	6 weeks	A responder during phase 1 or phase 2 is someone who demonstrated a 50% or greater decrease in HAMD-17 scores during phase 1 or phase 2 (corresponding).
Secondary	Change in 6-VAS-D Scores During Each Phase.	6 weeks

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	Hamilton Depression Rating Scale (HAM-D-17) Scores	6 weeks		points	MEAN
SECONDARY	Responder/Non-responder	6 weeks		percentage of patients	NUMBER
SECONDARY	Change in 6-VAS-D Scores During Each Phase.	6 weeks	Forms not analyzable due to insufficient standardization across sites.

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Category	Value	Spread	Units
Hamilton Depression Rating Scale (HAM-D-17) Scores	Ziprasidone Phase I	Mean phase baseline score	20.1	Standard Deviation 5.5	points
Hamilton Depression Rating Scale (HAM-D-17) Scores	Placebo Phase I	Mean phase baseline score	19.9	Standard Deviation 4.8	points
Hamilton Depression Rating Scale (HAM-D-17) Scores	Ziprasidone Phase II	Mean phase baseline score	14.7	Standard Deviation 3.9	points
Hamilton Depression Rating Scale (HAM-D-17) Scores	Placebo Phase II	Mean phase baseline score	15.6	Standard Deviation 5.9	points
Hamilton Depression Rating Scale (HAM-D-17) Scores	Ziprasidone Phase I	Mean phase score reduction	-8.8	Standard Deviation 7.3	points
Hamilton Depression Rating Scale (HAM-D-17) Scores	Placebo Phase I	Mean phase score reduction	-7.1	Standard Deviation 7.0	points
Hamilton Depression Rating Scale (HAM-D-17) Scores	Ziprasidone Phase II	Mean phase score reduction	-2.1	Standard Deviation 5.2	points
Hamilton Depression Rating Scale (HAM-D-17) Scores	Placebo Phase II	Mean phase score reduction	-4.3	Standard Deviation 6.0	points
Responder/Non-responder	Ziprasidone Phase I		44.8		percentage of patients
Responder/Non-responder	Placebo Phase I		31.8		percentage of patients

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow24

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

Period	Milestone	Group	Participants
Phase 1 SPCD	STARTED	Phase 1 Ziprasidone	29
Phase 1 SPCD	STARTED	Phase 1 Placebo	91
Phase 1 SPCD	STARTED	Phase 2 Ziprasidone	0
Phase 1 SPCD	STARTED	Phase 2 Placebo	0
Phase 1 SPCD	COMPLETED	Phase 1 Ziprasidone	17
Phase 1 SPCD	COMPLETED	Phase 1 Placebo	76
Phase 1 SPCD	COMPLETED	Phase 2 Ziprasidone	0
Phase 1 SPCD	COMPLETED	Phase 2 Placebo	0
Phase 1 SPCD	NOT COMPLETED	Phase 1 Ziprasidone	12
Phase 1 SPCD	NOT COMPLETED	Phase 1 Placebo	15

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events26

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	Sedation/Fatigue	Psychiatric disorders	Ziprasidone	13	125
other	Sedation/Fatigue	Psychiatric disorders	Placebo	3	80
other	Headache	Nervous system disorders	Ziprasidone	3	125
other	Headache	Nervous system disorders	Placebo	2	80
other	Insomnia	Psychiatric disorders	Ziprasidone	2	125
other	Insomnia	Psychiatric disorders	Placebo	3	80
other	Dizziness	Nervous system disorders	Ziprasidone	2	125
other	Dizziness	Nervous system disorders	Placebo	2	80
other	Blurry/Double Vision	Nervous system disorders	Ziprasidone	2	125
other	Blurry/Double Vision	Nervous system disorders	Placebo	2	80

1 to 10 of 26Source ClinicalTrials.gov

See all 26 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	Placebo
Total, other adverse events	Ziprasidone	31	125
Total, other adverse events	Placebo	22	80
Total, serious adverse events	Ziprasidone	0	80
Total, serious adverse events	Placebo	1	125

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23290327	RESULT	PubMed
25659187	DERIVED	PubMed

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 Placebo: 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/NCT00555997

GET https://conductscience.org/api/trials/v1/NCT00555997/flow?page=2

API reference For AI assistants