---
title: Neurobiological and Neurocognitive Disturbances in First-episode Schizophrenia
nct_id: NCT00207064
overall_status: COMPLETED
phase: NA
sponsor: Birte Glenthoj
study_type: INTERVENTIONAL
primary_condition: Schizophrenia
countries: Denmark
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00207064.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00207064"
ct_last_update_post_date: 2011-09-19
last_seen_at: "2026-05-12T06:35:51.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Neurobiological and Neurocognitive Disturbances in First-episode Schizophrenia

**Official Title:** 5-HT2A-receptor Binding: Implications for the Pathophysiology of Schizophrenia and Effects of Treatment With Antipsychotic Drugs

**NCT ID:** [NCT00207064](https://clinicaltrials.gov/study/NCT00207064)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 46
- **Lead Sponsor:** Birte Glenthoj
- **Collaborators:** Rigshospitalet, Denmark, Copenhagen University Hospital, Hvidovre, Glostrup University Hospital, Copenhagen, The Danish Medical Research Council, Copenhagen Hospital Corporation, University of Copenhagen, AstraZeneca
- **Conditions:** Schizophrenia
- **Start Date:** 2004-04
- **Completion Date:** 2008-09
- **CT.gov Last Update:** 2011-09-19

## Brief Summary

We want to relate disturbances in first-episode schizophrenic patients in serotonin 5-HT2A receptors, brain structure, brain function, and information processing to each other and to psychopathology. Additionally, we want to examine the influence of 5-HT2A receptor blockade on these disturbances. We expect disturbances in the serotonergic system at baseline to correlate with specific structural and functional changes and with disruption in information processing as measured with psychophysiological and neurocognitive methods - and we expect 5-HT2A receptor blockade to reverse some of the functional and cognitive impairments. We do not expect any effect of treatment on brain structure

## Detailed Description

Patients and matched healthy controls are examined at baseline and again after the patients have been treated for 6 months with a combined 5-HT2A- and dopamine D2- receptor blocker. We have chosen the atypical antipsychotic compound, quetiapine, for the present study since this drug is characterized by a fast koff/low affinity for the dopamine D2 receptors. The purpose of the study is to examine pathophysiological and neuropsychological mechanisms - not treatment effects. We want to characterize neurobiological and functional endophenotypes or vulnerability indicators and to study their stability over time and their relation to treatment and contemporary psychopathology. To the extent that candidate endophenotypes can be characterized as stable and independent of treatment and contemporary psychopathology they will be analysed together with similar findings from previous (identical)cohorts of schizophrenic patients. Specific disturbances will also be related to candidate genes for schizophrenia.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 45 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* First-episode schizophrenia. The controls are matched for age, gender and parental socioeconomic status

Exclusion Criteria:

* Previous antipsychotic treatment, mental retardation, organic brain damage, and for the controls a psychiatric diagnosis or first-degree relatives with a psychiatric diagnosis
```

## Arms

- **1** (EXPERIMENTAL)

## Interventions

- **quetiapine** (DRUG) — flexible doses according to the clinical condition

## Primary Outcomes

- **5-HT2A receptor binding and occupancy (PET)** _(time frame: Baseline and after 6 months)_
- **Structural MRI** _(time frame: Baseline and after 6 months)_
- **Functional MRI** _(time frame: Baseline and after 6 months)_
- **Information procession as measured with psychophysiological methods (P300, PPI, P50 gating ect.)** _(time frame: Baseline and after 6 months)_
- **An extensive battery of neurocognitive measures** _(time frame: Baseline and after 6 months)_

## Secondary Outcomes

- **PANSS** _(time frame: Baseline and after 6 months)_

## Locations (3)

- Neurobiology Research Unit, Rigshospitalet, Copenhagen, Denmark
- Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup, Glostrup Municipality, Denmark
- Danish Research Center for Magnetic Resonance Imaging, Hvidovre Hospital, Hvidovre, Denmark

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.neurobiology research unit, rigshospitalet|copenhagen||denmark` — added _(2026-05-12)_
- `locations.center for neuropsychiatric schizophrenia research, university of copenhagen, psychiatric center glostrup|glostrup municipality||denmark` — added _(2026-05-12)_
- `locations.danish research center for magnetic resonance imaging, hvidovre hospital|hvidovre||denmark` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT00207064*  
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