Trial · NCT00633399

Ziprasidone Augmentation of SSRIs for Patients With Major Depressive Disorder (MDD) That do Not Sufficiently Respond to Treatment With SSRIs

NCT00633399, 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. Ziprasidone Augmentation of SSRIs for Patients With Major Depressive Disorder (MDD) That do Not Sufficiently Respond to Treatment With SSRIs. Trials, record NCT00633399. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00633399

On this page

Trial

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

Title: Ziprasidone Augmentation of SSRIs for Patients With Major Depressive Disorder (MDD) That do Not Sufficiently Respond to Treatment With SSRIs
NCT number: NCT00633399
Status: Completed
Phases: Phase 2
Enrollment: 458 participants, actual
Lead sponsor: Massachusetts General Hospital
Conditions: Major Depressive Disorder
Interventions: Ziprasidone, Placebo
First posted: 2008-03-12
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	The Primary Outcome Measure Will be Response Rates (50% Decrease in HAM-D-17 Scores) During Phase 2	8 Weeks	The primary outcome measure will be response rates (50% decrease in HAM-D-17 scores) during phase 2. A responder will be a patient who experiences a 50% or greater decrease in symptoms according to the HAM-D-17 during phase 2.
Secondary	Remission Rates (HAM-D 17 Scores of Less Than 8) After Treatment Phase 2.	8 weeks	A secondary outcome measure will be remission rates (HAM-D 17 scores of less than 8) after treatment phase 2.. A remitted will be a patient with a final score of 7 or less on the HAMD-17 during phase 2.
Secondary	Comparing Scores on HAM-D 17 Baseline Visit to Phase 2 Final Visit at Week 8	8 weeks	This will involve looking at the change in HAM-D 17 scores during phase 2. For HAMD-17 the minimum is 0, the maximum is 52, and greater scores represent more symptoms.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	The Primary Outcome Measure Will be Response Rates (50% Decrease in HAM-D-17 Scores) During Phase 2	8 Weeks	Percentage of patients	NUMBER
SECONDARY	Remission Rates (HAM-D 17 Scores of Less Than 8) After Treatment Phase 2.	8 weeks	Percentage of patients	NUMBER
SECONDARY	Comparing Scores on HAM-D 17 Baseline Visit to Phase 2 Final Visit at Week 8	8 weeks	units on a 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
The Primary Outcome Measure Will be Response Rates (50% Decrease in HAM-D-17 Scores) During Phase 2	Ziprasidone + Escitalopram	35.2		Percentage of patients
The Primary Outcome Measure Will be Response Rates (50% Decrease in HAM-D-17 Scores) During Phase 2	Placebo + Escitalopram	20.5		Percentage of patients
Remission Rates (HAM-D 17 Scores of Less Than 8) After Treatment Phase 2.	Ziprasidone + Escitalopram	38		Percentage of patients
Remission Rates (HAM-D 17 Scores of Less Than 8) After Treatment Phase 2.	Placebo + Escitalopram	30		Percentage of patients
Comparing Scores on HAM-D 17 Baseline Visit to Phase 2 Final Visit at Week 8	Ziprasidone + Escitalopram	-6.4	Standard Deviation 6.4	units on a scale
Comparing Scores on HAM-D 17 Baseline Visit to Phase 2 Final Visit at Week 8	Placebo + Escitalopram	-3.3	Standard Deviation 6.2	units on a 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 + Escitalopram	71
Overall Study	STARTED	Placebo + Escitalopram	68
Overall Study	COMPLETED	Ziprasidone + Escitalopram	49
Overall Study	COMPLETED	Placebo + Escitalopram	53
Overall Study	NOT COMPLETED	Ziprasidone + Escitalopram	22
Overall Study	NOT COMPLETED	Placebo + Escitalopram	15

Source ClinicalTrials.gov

Adverse events28

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	Events
other	Somnolence and/or Fatigue	Nervous system disorders	Ziprasidone + Escitalpram	24	71	24
other	Somnolence and/or Fatigue	Nervous system disorders	Ziprasidone + Placebo	8	68	8
other	Akathisia	Nervous system disorders	Ziprasidone + Escitalpram	11	71	11
other	Akathisia	Nervous system disorders	Ziprasidone + Placebo	5	68	5
other	Headaches	Nervous system disorders	Ziprasidone + Escitalpram	5	71	5
other	Headaches	Nervous system disorders	Ziprasidone + Placebo	9	68	9
other	Irritability	Nervous system disorders	Ziprasidone + Escitalpram	7	71	7
other	Irritability	Nervous system disorders	Ziprasidone + Placebo	1	68	1
other	Poor concentration and/or memory	Nervous system disorders	Ziprasidone + Escitalpram	6	71	6
other	Poor concentration and/or memory	Nervous system disorders	Ziprasidone + Placebo	1	68	1

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ziprasidone + Escitalpram
Total, all-cause mortality	Ziprasidone + Placebo
Total, other adverse events	Ziprasidone + Escitalpram	51	71
Total, other adverse events	Ziprasidone + Placebo	42	68
Total, serious adverse events	Ziprasidone + Escitalpram	0	71
Total, serious adverse events	Ziprasidone + Placebo	0	68

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
26085041	DERIVED	PubMed
27306192	DERIVED	PubMed
27835715	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 + Escitalpram vs Ziprasidone + 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/NCT00633399

GET https://conductscience.org/api/trials/v1/NCT00633399/events?page=2

API reference For AI assistants