Trial Outcomes & Findings for Predictors of Response to Augmentation With Ziprasidone (Geodon®) in Major Depressive Disorder (NCT NCT01168674)

NCT ID: NCT01168674

Last Updated: 2017-02-24

Results Overview

Montgomery Asberg Depression scale improvement was assessed in two 6 week crossover periods. Minimum score on MADRS is 0, the maximum is 60. Higher scores represent a worse outcome, i.e., greater severity of depressive symptoms. Scores of about 20 and above are generally seen as consistent with being in a full major depressive episode. No subscales were used or combined.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 49 participants
• Primary outcome timeframe: 13 weeks (Two 6 week periods plus a one week washout)
• Results posted on: 2017-02-24

Participant Flow

Participant milestones

Measure	Placebo-washout-ziprasidone Placebo : The once-daily total daily dose will be 80-160 mg/d of the sugar pill. Dosing will begin at 20 mg BID with an escalation strategy based on target symptoms and tolerability, with a target dose range of 80-160 mg/d. Dose escalations will occur by increments of 20-40 mg weekly. This will be 6 weeks and then followed by a one week washout and then cross over to the other arm, Ziprazidone, for another 6 weeks, using same dosing techniques.	Ziprasidone-washout-placebo ziprasidone : Ziprasidone will be administered as a pill. The once-daily total daily dose will be 80-160 mg/d of ziprasidone. Dosing will begin at 20 mg BID with an escalation strategy based on target symptoms and tolerability, with a target dose range of 80-160 mg/d. Dose escalations will occur by increments of 20-40 mg weekly. This will be 6 weeks and then followed by a one week washout and then cross over to the other arm, Placebo, for another 6 weeks, using same dosing techniques.
Overall Study STARTED	25	24
Overall Study COMPLETED	25	24
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Predictors of Response to Augmentation With Ziprasidone (Geodon®) in Major Depressive Disorder

Baseline characteristics by cohort

Measure	All Study Participants n=49 Participants All participants were randomized to either placebo followed by ziprasidone crossover, or ziprsidone followed by placebo crossover.
Age, Continuous	42.6 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: 13 weeks (Two 6 week periods plus a one week washout)

Montgomery Asberg Depression scale improvement was assessed in two 6 week crossover periods.

Minimum score on MADRS is 0, the maximum is 60. Higher scores represent a worse outcome, i.e., greater severity of depressive symptoms.

Scores of about 20 and above are generally seen as consistent with being in a full major depressive episode.

No subscales were used or combined.

Outcome measures

Measure	Placebo n=49 Participants Subjects randomized to placebo in either the initial or crossover phase	Ziprasidone n=49 Participants Subjects randomized to ziprasidone in either the initial or crossover phase.
MADRS Improvement Over 6 Weeks	10.0 units on a scale Standard Deviation 10.3	6.7 units on a scale Standard Deviation 8.2

SECONDARY outcome

Timeframe: 13 weeks

Population: The most common predictor was antidepressant tolerance, as reported below in 37 subjects.

The specific bipolarity predictors in patients with MDD were assessed.

Outcome measures

Measure	Placebo n=49 Participants Subjects randomized to placebo in either the initial or crossover phase	Ziprasidone Subjects randomized to ziprasidone in either the initial or crossover phase.
Predictors of Bipolarity to Define the Study Population Antidepressant tolerance	75.0 percentage of subjects	—
Predictors of Bipolarity to Define the Study Population Antidepressant nonresponse	73.5 percentage of subjects	—
Predictors of Bipolarity to Define the Study Population Highly recurrent depressive episodes	72.3 percentage of subjects	—
Predictors of Bipolarity to Define the Study Population Atypical depression	52.9 percentage of subjects	—
Predictors of Bipolarity to Define the Study Population Family history of bipolar disorder	46.0 percentage of subjects	—
Predictors of Bipolarity to Define the Study Population Early age of onset	47.6 percentage of subjects	—
Predictors of Bipolarity to Define the Study Population Antidepressant-induced mania	8.8 percentage of subjects	—

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ziprasidone

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=49 participants at risk Placebo administered double-blind.	Ziprasidone n=49 participants at risk Active ziprasidone administered double-blind.
Nervous system disorders seizure	0.00% 0/49 • 13 weeks Adverse events are reported as ziprasidone arm events over placebo given the crossover nature of the study.	2.0% 1/49 • Number of events 1 • 13 weeks Adverse events are reported as ziprasidone arm events over placebo given the crossover nature of the study.

Other adverse events

Measure	Placebo n=49 participants at risk Placebo administered double-blind.	Ziprasidone n=49 participants at risk Active ziprasidone administered double-blind.
Nervous system disorders sedation	0.00% 0/49 • 13 weeks Adverse events are reported as ziprasidone arm events over placebo given the crossover nature of the study.	16.3% 8/49 • Number of events 8 • 13 weeks Adverse events are reported as ziprasidone arm events over placebo given the crossover nature of the study.
Gastrointestinal disorders nausea	0.00% 0/49 • 13 weeks Adverse events are reported as ziprasidone arm events over placebo given the crossover nature of the study.	8.2% 4/49 • Number of events 4 • 13 weeks Adverse events are reported as ziprasidone arm events over placebo given the crossover nature of the study.
Nervous system disorders dry mouth	0.00% 0/49 • 13 weeks Adverse events are reported as ziprasidone arm events over placebo given the crossover nature of the study.	8.2% 4/49 • Number of events 4 • 13 weeks Adverse events are reported as ziprasidone arm events over placebo given the crossover nature of the study.
Gastrointestinal disorders constipation	0.00% 0/49 • 13 weeks Adverse events are reported as ziprasidone arm events over placebo given the crossover nature of the study.	10.2% 5/49 • Number of events 5 • 13 weeks Adverse events are reported as ziprasidone arm events over placebo given the crossover nature of the study.

Additional Information

Dr. Nassir Ghaemi

Tufts Medical Center

Phone: 6176365735

Email: nghaemi@tuftsmedicalcenter.org

Results disclosure agreements

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