A phase I, multi-centre, double-blind,... — Clinical Trial Details

This multi-centre study randomised patients with DSM-IV major depressive disorder to receive a single IV infusion of ketamine (Part 1) or AZD6765 (Part 2) versus placebo to assess pharmacoMRI effects on BOLD signal in BA25 and other regions.

Secondary assessments included effects on emotional processing in amygdala and other areas, safety and pharmacodynamic/pharmacokinetic measures; follow-up visit occurred approximately 8–11 days after infusion for unresolved adverse events.

1. Female or male subjects aged 18-45 years, inclusive at enrolment.
2. Women of child bearing potential must have a negative serum pregnancy test and confirmed (by the Investigator) use of a highly effective form of birth control.
3. Documented clinical diagnosis meeting criteria from the DSM-IV by structured clinical interview (SCID) for 296.2x Major Depressive Disorder, Single Episode, or 296.3x Major Depressive Disorder, Recurrent.
4. Outpatient status at screening and randomisation.

1. Subjects with a DSM IV Axis II disorder which has a major impact on the subjects current psychiatric status.
2. Subjects with lifetime history of schizophrenia, bipolar, psychosis and psychotic depression.
3. Subjects’ use of mood stabilizers, antidepressants or other antipsychotic or psychoactive drugs within 14 days of Visit 2.
4. Subjects with a positive urine toxicology at screening (UTS) or at Visit 2 for cocaine and/or metabolites, amphetamines, opiates, phencyclidine (PCP), and barbiturates will be excluded except for subjects testing positive for prescribed medications; subjects can be re-tested but excluded if still positive.
5. OTC medicine within 48 hours prior to Visit 2 unless investigator judges it will not interfere with study procedures or safety.
6. Use of any medications that could confound MRI signal per judgement of Investigator.
7. Pregnancy or lactation.

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A phase I, multi-centre, double-blind, placebo-controlled parallel group study to assess the pharmacoMRI effects of AZD6765 in male and female patients fulfilling the criteria for Major Depressive Disorder

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Study Arms & Interventions

AZD6765

Interventions

Ketamine (Ketalar)

Interventions

Placebo

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details