Trial Outcomes & Findings for Effects of Antidepressant Therapy on Brain Dopamine Transporter Activity in People With Major Depression (NCT NCT00655057)
NCT ID: NCT00655057
Last Updated: 2020-04-16
Results Overview
COMPLETED
PHASE2/PHASE3
66 participants
Measured at Weeks 0 and 12
2020-04-16
Participant Flow
The investigator has succumb to serious health issues which prevents him from physically inputting data in the system. The study team is no longer at the university and despite all efforts to contact them in order to enter data on the investigator's behalf, data are not available.
Participant milestones
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Healthy Participants
Healthy participants will undergo TRODAT-1 SPECT imaging.
TRODAT-1 single photon emission computed tomographic (SPECT) imaging: Participants' striatal dopamine transporter (DAT) levels will be measured using \[99mTc\]TRODAT-1 SPECT with magnetic resonance imaging (MRI) co-localization on two separate occasions. Participants with depression will undergo TRODAT-1 SPECT imaging immediately before and after 12 weeks of their assigned treatment. Healthy participants will undergo TRODAT-1 SPECT imaging at baseline and 12 weeks later.
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Patients With Depression Without CBT
Participants with depression will undergo TRODAT-1 SPECT imaging and treatment with s-citalopram.
S-citalopram: Participants will take 10 to 30 mg of s-citalopram daily for 12 weeks.
TRODAT-1 single photon emission computed tomographic (SPECT) imaging: Participants' striatal dopamine transporter (DAT) levels will be measured using \[99mTc\]TRODAT-1 SPECT with magnetic resonance imaging (MRI) co-localization on two separate occasions. Participants with depression will undergo TRODAT-1 SPECT imaging immediately before and after 12 weeks of their assigned treatment. Healthy participants will undergo TRODAT-1 SPECT imaging at baseline and 12 weeks later.
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Patients With Depression: CBT and SPECT
Participants with depression will undergo TRODAT-1 SPECT imaging and treatment with cognitive behavioral therapy.
Cognitive behavioral therapy (CBT): Participants will attend twice weekly CBT sessions for 2 weeks and then once weekly sessions for 10 weeks. Sessions will focus on modifying thoughts and behaviors that may contribute to depression.
TRODAT-1 single photon emission computed tomographic (SPECT) imaging: Participants' striatal dopamine transporter (DAT) levels will be measured using \[99mTc\]TRODAT-1 SPECT with magnetic resonance imaging (MRI) co-localization on two separate occasions. Participants with depression will undergo TRODAT-1 SPECT imaging immediately before and after 12 weeks of their assigned treatment. Healthy participants will undergo TRODAT-1 SPECT imaging at baseline and 12 weeks later.
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Overall Study
STARTED
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Overall Study
COMPLETED
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Overall Study
NOT COMPLETED
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Antidepressant Therapy on Brain Dopamine Transporter Activity in People With Major Depression
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Measured at Weeks 0 and 12Population: The investigator has succumb to serious health issues which prevents him from physically inputting data in the system. The study team is no longer at the university and despite all efforts to contact them in order to enter data on the investigator's behalf, data are not available.
Outcome measures
Outcome data not reported
Adverse Events
Healthy Participants
Patients With Depression Without CBT
Patients With Depression: CBT and SPECT
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place